ADME Scientific Lead – Switzerland
A fantastic opportunity has become available at a leading Pharmaceutical company renowned for its diverse and innovative work culture. The company requires a senior PhD scientist to work within the Drug Metabolism and Pharmacokinetics department (DMPK) providing scientific excellence in in vivo ADME/PK studies.
In this role you will:
- Manage an in vivo ADME/PK lab and supervise direct reports
- Provide excellent and well documented results on internal and/or outsourced in vivo studies/publications
- Represent the DMPK line function in project and sub teams
- Present findings at cross-functional and departmental meetings
- Be responsible for the assessment and training of staff members
- Contribute to projects from discovery right through to the market
- A Ph.D. in a relevant Life Science subject
- Strong working knowledge of DMPK, in vivo ADME and / or PK/PD studies
- At least 5 years experience in drug development
- Familiarity with in vivo formulation and in silico tools
- Hands on experience in Pharmacokinetics
- Internationally competitive salary
- Career progression
- Supported personal development
Contact Francesca at +44 1273 727 930 or fran@stelfoxuk.com
Francesca is a Search expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia.
Contact email address: fran@stelfoxuk.com - 14th Jun 2013 [2399]
Laboratory Manager in vivo ADME/PK – Switzerland
A fantastic opportunity has become available at a leading Pharmaceutical company renowned for its diverse and innovative work culture. The company requires a senior PhD scientist to work within the Drug Metabolism and Pharmacokinetics department (DMPK) providing scientific excellence in in vivo ADME/PK studies.
In this role you will:
- Manage an in vivo ADME/PK lab and supervise direct reports
- Provide excellent and well documented results on internal and/or outsourced in vivo studies/publications
- Represent the DMPK line function in project and sub teams
- Present findings at cross-functional and departmental meetings
- Be responsible for the assessment and training of staff members
- Contribute to projects from discovery right through to the market
You will bring to the role:
- A Ph.D. in a relevant Life Science subject
- Strong working knowledge of DMPK, in vivo ADME and / or PK/PD studies
- At least 5 years experience in drug development
- Familiarity with in vivo formulation and in silico tools
- Hands on experience in Pharmacokinetics
If you are a successful candidate, you will benefit from:
- Internationally competitive salary
- Career progression
- Supported personal development
If you have the skills and experience for this opportunity and the ambition to take on this position, please call Francesca for further details or email your CV today.
Contact Francesca at +44 1273 727 930 or fran@stelfoxuk.com
Francesca is a Search expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia.
Contact email address: susan.m.dipaglia@pfizer.com - 11th Jun 2013 [2397]
Pfizer – Clinical Pharmacology Lead - Job ID 982501, location La Jolla, CA
The Clinical Pharmacology Leads (CPLs) are responsible for providing the clinical pharmacology components of clinical plans and provide clinical pharmacology expertise to the project team.
CPLs utilize innovative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and diseases for rational development strategies and decisions, as well as optimal study designs and dosage regimen selections.
Technical responsibilities
- Accountable and responsible for the clinical pharmacology deliverables for the assigned projects within sphere of influence
- Responsible for appropriate clinical pharmacology input on project teams and contribution of clinical pharmacology expertise and leadership to a project
- Responsible for ensuring planning and direction of clinical pharmacology components on the clinical project level (including clinical development plan) and studies (including synopsis preparation, clinical phase oversight, reporting)
- Responsible for implementing clinical pharmacology best practices on project team
- Responsible for ensuring clinical pharmacology leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensuring overall scientific accountability for the designated studies.
- Responsible (with clinicians and statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients
- Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan that conforms with best practices
- Responsible for ensuring use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs
- Responsible for ensuring appropriate summary and interpreting results of pharmacokinetic/pharmacodynamic analyses with respect to their impact on development and clinical use of drugs.
- During the pre-clinical stages of drug development, works closely with colleagues in other disciplines to ensure that sufficient preclinical PK-PD knowledge exists to underwrite safe human administration and to establish the structure of a predictive model
- Accountable for ensuring that there are valid methods for measuring drug concentration (and any biochemical biomarkers) for human studies
A PhD or MD/PhD in Pharmacology or related scientific field in combination with relevant experience (Level of appointment is determined on experience level).
Preferred Educational Qualifications: A PhD in Pharmacology/Pharmacy/Biological Sciences with hands on quantitative skills and 3-10 years of relevant industry experience.
External website http://www.pfizercareers.com
Contact email address: broseberry@cartermackay.com - 5th Jun 2013 [2396]
Senior Director, PK and ADME
My client is seeking an experienced PhD to lead the development of nonclinical drug metabolism and PK/PD. This position will manage direct reports and work in cross disciplinary project teams. Will be responsible for directing metabolism, PK, TK, and DDI for both large and small molecule compounds. Will cover discovery through POC and into translational. Will also be responsible for dose selection for preclinical studies as well as FIH. Additionally, will oversee preclinical PK/PD data analysis. Will contribute to the preparation of relevant sections of regulatory documents such as IND, IB, NDA, and BLA's. Must have alteast 12 years experience for the Sr Director role and an established track record in PK/PD and related areas as well as success in moving compounds through the nonclinical/preclinical process in preparation for the clinic. Please send questions and resumes to broseberry@cartermackay.com
Contact email address: broseberry@cartermackay.com - 3rd Jun 2013 [2394]
Project Manager, pharmacology and pharmacokinetics (united states)
Seeking a PhD with 5+ years of experience in pharmacokinetics/pharmacology. Must be familiar with working in project teams and in a cross scientific environment. In this role, you have the opportunity to manage projects from discovery through clinical, including late phase clinical. Among the responsibilities in this role, you will manage IND enabling studies, review clinical pahrmacology study protocols, provide clinical trial support, conduct PK modeling and noncompartmental analysis with WinNonLin and NONMEM, and will also write study reports and relevant sections of regulatory documents such as IND and NDA's. The candidate should have extensive knowledge in PK and how compounds are moved through the development process, as well as understanding of areas such as ADME and bioanalysis. A PhD and a minimum of 5 years experience is required. Must also have solid communication skills. Please send CV's or questions to broseberry@cartermackay.com
Contact email address: fatemeh@uri.edu - 2nd Jun 2013 [2393]
Postdoctoral Research Associate, Pharmacokinetics or Drug Metabolism Pharmacokinetics Research Laboratory College of Pharmacy, University of Rhode Island
Pharmacokinetics Research Laboratory within the Department of Biomedical and Pharmaceutical Sciences, University of Rhode Island invites applications for 2-3 postdoctoral research associates. The laboratory is supported by various grants from the National Institutes of Health is located in a brand-new, state-of-the-art research facility.
Major emphasis of the laboratory includes understanding the effect of diabetes or alcohol abuse on drug metabolism and effect. The research will involve characterization of expression and regulation of drug metabolizing enzymes and clinical studies in the area of pharmacokinetics (PK) and pharmacodynamics (PD). Training in PKPD modeling will be provided to suitable candidates. Successful applicant will conduct basic and translational research, attend seminars, teach students, review and write research proposals and compose manuscripts for publication.
Highly motivated individuals with exceptional record of academic achievement and a PhD in pharmacology, drug metabolism, mass spectrometry, pharmaceutical sciences and toxicology, are encouraged to apply. Experience with drug metabolism, drug transport, PKPD modeling, LC-MS/MS, cell culture, genotyping and handling laboratory animals are desirable.
Competitive candidates are expected to have excellent oral and written communication skills, and a strong record of peer reviewed publications. The position is available immediately until a suitable candidate is found. The University of Rhode Island is an AA/EEOD employer and values diversity.
For further information, please contact:
Fatemeh Akhlaghi, PharmD, PhD Professor Biomedical and Pharmaceutical Sciences University of Rhode Island 495A College of pharmacy 7 Greenhouse Road Kingston, RI 02881 USA Phone: (401) 874 9205 Fax: (401) 874 5787 Email: uripkpostdoc@gmail.com
External website http://www.uri.edu/pharmacy/faculty/aps/akhlaghi/
Contact email address: fran@stelfoxuk.com - 1st May 2013 [2392]
Manager Pharmacokinetic Analysis and Reporting, Switzerland
An international pharmaceutical company is looking for an experienced PK scientist to join them in this newly created role.
In this role you will:
- Manage an experienced team of scientists with responsibility for performance, retention, work prioritization and allocation of resources
- Manage externally conducted PK and TK studies whilst also taking responsibility for the evaluation and reporting of studies carried out internally within Research and Development
- Devise and conduct PK in vivo studies
- Carry out meta analysis and data plots and contribute to the design of database and document repositories for PK and TK data
- Maintain extensive and productive collaborations with key personnel within Nonclinical Safety
- A PhD
- A minimum of 3 years experience gained within the pharmaceutical/biotechnology sector
- Proven hands on experience in pharmacokinetics and a good knowledge of software (e.g. WinNonlin)
- Ability to manage CROs and foster productive working relationships
- An interest in data analysis/mining
- Experience mentoring/managing other scientists
- Fluency in English
- Competitive salary and fantastic career growth prospects
- International and dynamic working environment
- The opportunity to positively work towards bettering human health
- Relocation support
Contact Francesca at +44 1273 727 930 or fran@stelfoxuk.com
Francesca is a Research & Development Search expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia.
Keywords: PK, TK, Pharmacokinetic, Toxicokinetic, outsource, external, vivo, study, CRO, PhD, preclinical, rodent, species, data analysis, Europe, Switzerland, Germany, France, UK, Spain, Netherlands, Sweden, scientist, manager, laboratory, Senior, Principal
Contact email address: smcdonal@usa.ibm.com - 25th Apr 2013 [2391]
Staff Scientist/ Sr. Staff Scientist - PK Modeling
Tarrytown, NY
# 717BR
www.regeneron.com
If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.
The Preclinical Pharmacokinetics Group is looking for a Staff Scientist, reporting to a Director, Preclinical Pharmacokinetics. This individual will serve as a key contributor in the Preclinical Pharmacokinetics group. Responsibilities include, but are not limited to:
- Protocol design-input for PK & TK studies, generating & evaluating data, and authoring company reports
- Modeling PK data using PK modeling software for non-compartmental and multi-compartment analyses
- Serve on project teams, representing preclinical PK and provide PK expertise
- Work closely with preclinical Bioanalytical group to ensure transparency of data transfer-sharing, and, with Toxicology, Clinical and Regulatory, as required, to provide PK perspective on assigned projects.
- Experience in designing animal pharmacokinetic and toxicokinetic studies
- An understanding of drug development & the role of pharmacokinetics
- Good understanding of both theoretical pharmacokinetic theory of macromolecules and practical application of these principles
- Experience with PK software and conducting non-compartment & multi-compartment modeling
- Experience in working in a GLP environment and following SOPs
- Excellent scientific writing skills
We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
External website http://www.regeneron.com
Contact email address: peter.gennemark@astrazeneca.com - 24th Apr 2013 [2390]
Two PhD/early stage research studentship available in a Marie Curie EU-funded joint project by University of Warwick, AstraZeneca, Fraunhofer-Chalmers Research Centre for Industrial Mathematics, and Swedish University of Agricultural Sciences.
Application deadline: 17th May 2013
Start date: 1st June 2013
Duration: Three years
PROJECT MJC-01: Modelling Dose Response Time Outcome Relationships
The project addresses the development and improvement of methodologies for analyzing dose-response-time data when systemic (plasma) exposure is sparse or lacking. Extending and applying tools and techniques from systems and control theory and in particular nonlinear estimation such as Kalman filtering will be central to developing methodology for this situation. Dose-response-time data analysis (DRT) enables us to more efficiently (quantitatively) analyze and draw conclusions about the underlying rate processes where traditional single-point assessment or area under the response-time curve approach generally fail. Hopefully, this also allows a more robust design tool for future pharmacodynamic experiments in both animals and man. The candidate student should have a strong background (MSc or equivalent) in biological engineering/numerical techniques/computing science/chemical engineering, and life science courses. A track record in pharmacokinetics/dynamics would also be beneficial.
PROJECT MJC-05: Deconvolution in non-linear ordinary differential equations for Quantitive and Systems Pharmacology
The project addresses the development and improvement of methodologies for identifying unknown mathematical relationships in a (nonlinear) pharmacological system where only certain state variables are observed and where data are sparse and noisy. This will lead to an improved understanding of system properties, thus increasing confidence in the selection between prospective compounds and providing more robust design tools for drug discovery. The candidate student should have a strong background in mathematics/computing science, and ideally, have taken life science courses or even pharmacokinetics/dynamics courses.
The successful applicants will receive a stipend of £46,000 per annum over three years.
For online application:
MJC-01 -
http://ec.europa.eu/euraxess/index.cfm/jobs/jobDetails/33847443
MJC-05:
http://ec.europa.eu/euraxess/index.cfm/jobs/jobDetails/33847444
External website http://ec.europa.eu/euraxess/index.cfm/jobs/jobDetails/33847443
Contact email address: broseberry@cartermackay.com - 10th Apr 2013 [2388]
Pharmacokineticist opening!! (United States) My client is a stable, global pharmaceutical company with an excellent group of PK scientists to work with. We are seeking a PhD with experience in clinical PK/PD. Above and beyond the understanding of study design and data analysis, we are seeking someone that is interested in project management and identifying and developing new PK/PD models and working with other groups across multiple disciplines to further the development of PK/PD strategies. Will be the key contributor to PK/PD reports, regulatory filings, and protocols. Will also author in peer reviewed journals. Must have excellent communication skills and the ability to multitask with impeccable work ethic. Required: PhD in pharmacokinetics or related discipline and 0-6 years of experience. Salary and title will be commensurate. Send resumes or questions to broseberry@cartermackay.com (720-328-9526)
Contact email address: jballesteros@viviabiotech.com - 31st Mar 2013 [2382]
Job title: Specialist in Pharmacometry for Personalized Medicine.
Job description: Vivia is pioneering personalizing treatments in blood cancers by evaluating directly in patient samples the pharmacological effect of real-life treatments in eliminating individual patient tumor cells. We have collected a wealth of data on ~40 individual drugs and ~100 drug combination treatments in terms of dose responses in more than 400 patient samples for 4 indications. Candidate will lead the internal effort to analyze this pioneering wealth of data with NOMEN and population models. This analysis is achieving 90% prediction rates enabling launching sales in Q3 2013. This is a key position within the company and we are flexible on the position and salary based on candidates profiles.
Job requirements: PhD in pharmacokinetics, pharmacometrics, or related scientific field Pharmacokinetics and Phamacodynamics. Candidate must have 5-10 years hands-on experience and knowledge of analysis and modeling software (i.e. NONMEM, Phoenix NLME and CTS, Berkeley Madonna) and statistical software (R, S+, etc.). We will use NOMMEN 7.2 and population modeling approaches.
Work Environment: This position is based in Madrid, Spain. It requires significant interactions with internal colleagues from other departments and with external colleagues and consultants. Vivia provides a highly motivational environment where all scientists understand that our personalized medicine test implies that the result of their work every day can mean life or death for an individual cancer patient, a rare employment opportunity that needs to be taken into account very seriously.
Vivia Biotech: Launched in September 2007, Vivia Biotech raised €4 M in seed capital with VC Funds, a record in Span, and has recently raised a new round of €7 M to launch sales of its PM test. Vivia Biotech is a worldwide pioneer in the "screening" and profiling of thousands of drugs on a patient blood samples, thanks to the ExviTech technological platform. This platform, ExviTech, developed originally at USA by an American team moved to Spain to start up Vivia, a pioneer company with international recognition that has been able to take scientific advantage at Spain’s world leadership in terms of altruistic donation of organs and samples for research. Vivia´s team is formed by 28 highly qualified professionals, dedicated to improving the life expectancy and quality of patients with blood cancers.
External website http://www.viviabiotech.com
22nd Mar 2013 [2380]
Scientist, ADME Non-clinical PK/PD
Novartis Institutes for BioMedical Research – Basel, Switzerland
Description:
The Drug Metabolism and Pharmacokinetics (DMPK) Department at the Novartis Institutes for BioMedical Research (NIBR) is looking for an independent degree-qualified scientist with a strong background in ADME/Pharmacokinetics to join their multidisciplinary non-clinical PK/PD group to perform state-of-the-art in-vitro and in-vivo ADME studies. Work location will be Basel, Switzerland.
Developing within the role, you will have the opportunity to take over responsibility for directing in-vitro studies independently. The group’s pool setup allows associates to constantly broaden their portfolio of scientific techniques by contributing to multiple projects across lab boundaries.
Main accountabilities include:
- Plan, conduct, analyze and document in-vitro plasma protein binding, blood distribution, skin permeation studies. Work independently, prepare protocols, evaluate and interpret results, draws relevant conclusions, write reports, and effectively communicates results (70%)
- Conduct in-vivo ADME and pharmacokinetics studies (30%)
- Recognize and solve complex problems (e.g. optimizes instrument parameters, proposes different procedure / assay, adaptation of study protocol).
- Apply a broad range of separation/detection techniques (such as ultrafiltration, equilibrium dialysis, gel filtration, LC, liquid scintillator counting).
- Optimize existing in-vitro plasma protein binding methods/approaches and implements new methods/approaches.
Skills and experience required:
- Master’s or Bachelor degree (no PhD) in biological related sciences with some years of lab experience, preferably in the pharmaceutical or biotechnology industry
- Understanding and knowledge of techniques, instrumentation, and underlying principles within ADME/PK field
- Experience in independently running experiments, be able to perform data analysis and interpretation, write protocols and reports
- Working experience in the animal experimentation area (animal handling, drug application, blood/tissue sampling) advantageous
- Hands-on working experience with radioactivity (3H/14C) and liquid scintillator counting preferable
- Familiarity with laboratory quality guidelines (GLP) advantageous
- Advanced computer literacy (Microsoft Office); experience using Phoenix Winnonlin
- Team player with excellent communication skills
- Ability to work effectively within a highly matrixed team environment
- Fluent in English (spoken and written); German and/or French would be an asset
Please apply online at www.novartis.com/careers using Job ID 115022BR.
External website http://www.novartis.com/careers/job-search/index.shtml
22nd Mar 2013 [2378]
Lab Head/Study Director, ADME in non-clinical PK/PD
Novartis Institutes for BioMedical Research – Basel, Switzerland
Description:
The Drug Metabolism and Pharmacokinetics (DMPK) Department within the Novartis Institutes for BioMedical Research (NIBR) in Basel, Switzerland, is recruiting for a PhD-level scientist with experience in in-vivo ADME/PK studies to join their multidisciplinary non-clinical PK/PD team to strengthen the department’s in-vivo capabilities.
As a Study Director, you will deliver quality and timely results on internal and/or outsourced studies and represent those at cross-functional teams and department meetings. As a laboratory head, you will ensure adequate training and supervision of technical staff as well as assessment of their performance (1-2 technicians). The laboratory will focus on ADME/PK, formulation, and/or PK/PD studies in preclinical animal models.
Furthermore, you will represent the DMPK line function in DMPK sub teams and project teams, present findings in teams, document results in internal and external reports/publications and contribute to registration documents.
Skills and experience required:
- PhD in a relevant life science discipline
- Strong expertise in DMPK, ADME, and/or PK/PD
- Proven ability to design, supervise and interpret various types of in vivo ADME/PK studies
- Proficiency in the development/optimization of new/existing in vivo and/or in situ experimental methods for elucidation of pharmacokinetic questions like absorption, distribution, elimination etc.
- Strong understanding and hands-on experience in pharmacokinetics
- Beneficially, familiar with imaging techniques and/or in vivo formulation development and/or in silico tools, e.g. PK scaling methods for AHD, PK/PD
- Strong analytical thinking, excellent communication skills and the proven ability to work independently as well as effectively within a team environment
- Good understanding of the drug development process
- Proven ability to manage, motivate, and direct technical staff
- Excellent oral and written communication skills in English; some knowledge of German or French considered beneficial
Please apply online at www.novartis.com/careers using Job ID 114635BR .
External website http://www.novartis.com/careers/job-search/index.shtml
20th Mar 2013 [2376]
Senior Investigator, Clinical PK/PD
Novartis Institutes for BioMedical Research – Basel, Switzerland
Description:
The Drug Metabolism and Pharmacokinetics (DMPK) Department within the Novartis Institutes for BioMedical Research (NIBR) in Basel, Switzerland, is recruiting for a degree-qualified scientist to join their clinical Pharmacokinetics/Pharmacodynamics (PK/PD) team.
In this position you will manage projects (with focus on specific therapeutic areas) and negotiate an optimal PK/PD strategy for early and full development in liaison with appropriate line functions and with Management input as appropriate.
Furthermore, you will be responsible for the PK, PK/PD and M&S component of study protocols, reports, project summaries and development plans within agreed timeframes and which meet regulatory requirements.
Main accountabilities include:
- Define PK, PK/PD biopharmaceutical and M&S requirements in project development plans and appropriate strategies for global registration
- Analyze, interpret and represent PK, PK/PD and M&S data generated during development and provide guidance through recommendations
- Coordinate with appropriate sub-team members and other LF experts for the preparation of, and/ or prepare (when needed) summary documentations on drug metabolism and pharmacokinetics as required by ethics committees and HAs (IB, BB, CTA/IND), responses to HAs)
- Proactively manage links with other functions to ensure that pre-clinical and clinical PK/PD information are used optimally for added value and integrated into early and late phase development plans
- Directly or indirectly take the lead on appropriate pharmacokinetic/biopharmaceutical studies
Skills and experience required:
- PhD or PharmD with biological background or Master’s degree in Biology, Pharmaceutical Sciences or a similar relevant discipline
- Significant work experience in drug development or another relevant environment such as Clinical Pharmacology or Drug Metabolism and Pharmacokinetics
- Proven knowledge of PK and PK/PD evaluation techniques
- Experience of working in project teams (preferably global) and sound awareness of recent developments in drug development sciences essential
- Knowledge of regulatory requirements and experience in dealing with regulatory authorities
- Strong analytical thinking, excellent communication skills and the proven ability to work independently as well as effectively within a matrix environment
- Fluent English (oral and written)
Please apply online at www.novartis.com/careers using Job ID 107244BR
External website http://www.novartis.com/careers
Contact email address: broseberry@cartermackay.com - 19th Mar 2013 [2375]
Director, Clinical Pharmacokinetics (United States)
Seeking a PhD with 8-15 years experience that is looking for a role that will manage across scientific disciplines and have high impact and visibility. Will have hands on scientific involvement and play an active role in the design and analysis of clinical PK studies and data. Will also oversee outsourced studies to CRO partners. Must understand PK modeling data from WinNonLin, NONMEM, etc. Will be expected to contribute to regulatory filings such as IND's and NDA's as well as integrate preclinical and clinical data. This individual will be a scientific leader within the company and play an integral role in the development of drug candidate compounds. For more information or to apply, please send resumes or questions to broseberry@cartermackay.com
15th Mar 2013 [2374]
Principal Scientist, Pharmacometrics
The individual will provide expertise in the area of pharmacometrics (PM) and pharmacokinetic-pharmacodynamics to the project teams and will be responsible for the conduct, summary, and interpretation of pharmacokinetic-pharmacodynamic results and impact on the program. This person will utilize innovative methods to integrate knowledge of PM, pharmacokinetics (PK), pharmacodynamics (PD), patient characteristics and disease for clinical development strategy, clinical trial design, and dosage regimen selection. The ideal candidate in this role will be expected to initiate and support the establishment and integration of modeling and trial simulation, in order to enhance the transition of compounds from preclinical, into man, through Phase III development and regulatory submission.
Major Responsibilities:
- Accountable and responsible for non-compartmental and model-dependent analysis of PK data and conduct of appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, and meta analysis,
- Conduct PM and PK-PD analysis and provide expertise to the development and clinical teams
- Responsible for conduct, summary and interpretation of PK-PD results and impact on the program
- Accountable for appropriate design and implementation of a clinical modeling and simulation plan that conforms to regulatory guidelines
- Responsible for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients
- Responsible for use of innovative methods to integrate the knowledge of PK-PD, patient characteristics, and disease states to optimize dose selection and study design
- During pre-clinical stages of drug development work with non-clinical development to ensure that appropriate pre-clinical PK/PD knowledge exists for safe human dosing and to establish the structure of a predictive model
- PhD in pharmacokinetics, pharmacometrics, or related scientific field with minimum of 8 years of relevant industry experience in multiple therapeutic areas including infectious diseases
- Candidate must have hands-on experience and knowledge of analysis and modeling software (i.e. NONMEM, Phoenix NLME and CTS, Berkeley Madonna) and statistical software (R, S+, etc.)
- Candidate must have hands on quantitative skills and demonstrate a thorough understanding of the following: 1) principals of PK-PD, and 2) quantitative model based drug development and application of these approaches to drug development.
- Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process FDA and ICH guidelines in the design of clinical development and trials.
- Strong communication skills; verbal, written and presentation. Medical scientific writing skills must be strong.
External website http://www.cubist.com/careers/
14th Mar 2013 [2372]
Unilever R&D Vlaardingen is looking for a R&D Manager - Research Scientist PK & ADME
Key responsibilities The primary role of is to serve as representative in multi-disciplinary R&D teams, providing expertise and guidance on all aspects of PK/ADME studies. You will have line management responsibilities.
Main accountabilities You will be responsible for the delivery of assigned projects on time & in full. More specifically, you will:
- Line-manage a technical staff group. You will do this through coaching and training, career planning that will allow and encourage people to reach their full potential
- increase our capability in PK/ADME and design and execute human studies,primarily for the Foods program
- strengthen our formulation capability to provide solutions for actives
- translate project objectives and scientific insights into research proposals in the area of bioavailability & ADME spanning from in-vitro to in-vivo work
- establish collaborations with external partners and strengthen contacts with academic partners in the field
- assess internal and external scientific developments and evaluate their relevance for Unilever
Key skills You are ideally educated with a PhD, preferably with post-doctoral experience, in nutritional physiology, pharmacology or bio-pharmaceutics. You have a scientific background in pharmacokinetics and bioavailability. Knowledge on formulation aspects of solid and liquid dosage forms as well as human PK dose-projections are required. Excellent communication and leadership skills as well as effective interpersonal skills and the ability and experience to work in teams across disciplines and line manage a team of lab technicians is considered as very important.
To apply, you must do so online. For full description see: https://unilever.taleo.net/careersection/external/jobdetail.ftl?job=37041&lang=en&sns_id=linkedin
External website http://https://unilever.taleo.net/careersection/external/jobdetail.ftl?job=37041&lang=en&sns_id=link
10th Mar 2013 [2370]
Expert for Statistical Methods in the Life Sciences (m/f)
Bayer Technology Services GmbH, Leverkusen
Job description
You will be responsible for the development and application of statistical methods on pharmaceutical and biological problems in such areas as pharmacokinetics, bridging and stratification. Your tasks could also include the application of statistical approaches to production and quality issues and the scientific refinement of the respective statistical methods. You will perform scientific analyses of the results and communicate these to the customer. You will also be responsible for supervising students and PhD candidates.
Your qualifications
You are educated to an university degree in the natural sciences with an emphasis on statistics, and preferably have a PhD in this field. Ideally, you will already have experience with the development and application of statistical methods on biological problems. You should also be familiar with optimization issues. You have a sound knowledge of R or Matlab software. Knowledge of Markov chain Monte Carlo methods and SAS would also be advantageous. You enjoy working in a team and have good communication skills. You are proficient in English.
Your application
We offer a performance-based income and very good opportunities for professional and personal development. If you welcome the personal challenge posed by the multiple aspects and responsibility of these tasks, please apply online with your application documents (cover letter, resume, references).
www.myBayerjob.de
Phone +49 214 30 99779
Reference Code: 0000052696
Bayer welcomes applications from all individuals, regardless of racial or ethnic origin, skin color, nationality, religion, philosophy, gender, age, disability, appearance or sexual identity. We are committed to treating all applicants fairly and avoiding discrimination.
External website http://www.systems-biology.com/jobs.html
10th Mar 2013 [2369]
Mechanistic Modelling and Simulation Expert (m/f)
Bayer Technology Services GmbH, Leverkusen
Leveraging Bayer's unique position in Life Sciences: Research at the interface of human, animal and plant health.
Job description
Your tasks at Bayer Technology Services GmbH will lie in the design and creation of mechanistic models in the areas of pharmacokinetics and pharmacodynamics. You will also provide consulting to customers from pharmaceutical research and development on computational life sciences. You will also be responsible for the scientific analysis of the results and their communication to the customer.
Your qualifications
You have a PhD in the natural sciences (pharmacy, biology, chemistry, physics or mathematics) and the relevant knowledge in the fields of pharmacokinetics and pharmacodynamics. You also understand the fundamentals of mechanistic modeling methods. You ideally have several years of experience in the area of disease modeling. You are willing to work in an interdisciplinary team and are fluent in both spoken and written English.
Your application
We offer a performance-based income and very good opportunities for professional and personal development. If you welcome the personal challenge posed by the multiple aspects and responsibility of these tasks, please apply online with your application documents (cover letter, resume, references).
www.myBayerjob.de
Phone +49 214 30 99779
Reference Code: 0000052679
Bayer welcomes applications from all individuals, regardless of racial or ethnic origin, skin color, nationality, religion, philosophy, gender, age, disability, appearance or sexual identity. We are committed to treating all applicants fairly and avoiding discrimination.
External website http://www.systems-biology.com/jobs.html
5th Mar 2013 [2366]
Sr. Scientist/Principal Scientist - PK/PD Modeling & Simulation (Infection) - AstraZeneca (Waltham, MA)
Major responsibilities:
- Deliver the preclinical and translational PKPD modeling on diverse targets/indications to project teams, from Target Validation to Early Development stage.
- Deliver M&S activities to projects such as PKPD modeling; modeling of disease progression and biomarker response; prediction of human PK and simulations of clinical efficacious doses; drug-drug interaction predictions and risk assessments; modeling of TK/TD data to support projects on understanding safety liability and identifying optimal dose regimen to prevent toxicity.
- Drive the quantitative pharmacology strategy into projects, use and refine best practice to ensure a Modeling & Simulation continuum from pre-clinical to clinical.
- Effectively collaborate with Bioscience, Safety, Clinical Pharmacology and Pharmacometrician on the design of pre-clinical forward and backward translational PKPD and TKPD studies and contribute to reporting results to project teams.
- Contribute to the PKPD part of internal reports and regulatory documents (e.g. IND, IMPD, IB, NDA).
- Contributes to the development and implementation of external collaborations in the M&S field that respond to the emerging science and meet the short and long term needs of the drug discovery and development portfolio.
- Is an effective mentor for more junior M&S, PK and TK scientists and helps them solve their issues through development of their technical/scientific skills and through the appropriate leadership capabilities.
- Plays an active part in external influencing strategy for Modeling & Simulation discipline through publication of manuscripts and external presentations.
- Create a vibrant and innovative working environment where improvements and new ideas are adopted and freely shared among the teams.
Other Responsibilities
- Ensure compliance with corporate code of conduct guidance and ensuring adherence to best SHE practice.
- Deliver PKPD and TKPD modeling and strategy to project teams within the agreed timelines and to a high quality.
- PhD in Pharmaceutical Science, applied mathematics, pharmacokinetics, pharmacodynamics or other relevant discipline in Modeling & Simulation, plus 2+ years of experience in Pharmaceutical R&D.
- Comprehensive understanding of DMPK and pharmacology/safety aspects of drug discovery and development.
- Track record of PK, PKPD and TKPD in projects, with a delivery focus and ability to meet timelines to pre-specified quality and cost.
- Specialist in tools such as WinNonLin/Phoenix, NonMem, Berkeley Madonna, R, and SIMCYP.
- Experience in operating cross-functionally.
External website http://www.candidatecare.com/srccsh/RTI.home?r=2000019708810&d=astrazeneca.candidatecare.com
5th Mar 2013 [2364]
DMPK-NBE Project Representative (m/f)
DMPK Project Representative (m/f) is a strategic and scientific position within DMPK, responsible for the overall nonclinical DMPK contribution to NBE projects from hit optimization up to LCM to fulfill the internal and regulatory requirements.
Your key tasks and responsibilities are:
Provide the scientific leadership in DMPK to drive projects through the different discovery and development stages Represent the DMPK function in the NCD team and the project teams and act as interface between the NCS leader and the DMPK function May assume the role of NCS-Leader, representing the NCD function as core team member in development projects Ensure that the DMPK studies within the given project are conducted according to the agreed timelines and the required quality depending on the stage of the projects Ensure that the DMPK plans/issues are discussed, also dependent on the stage of the molecule, appropriately within the function and that an agreed position is reached before giving feedback outside the function Prepare the DMPK project development plan, in collaboration with all the group experts within the DMPK functions (Exploratory & Development DMPK and Bioanalytics) Provide the DMPK section of regulatory documents and documents used for internal decision making (e.g. DP0 Report, Investigator Brochure, IMPD, IND) Provide adequate support to the NCS-L for DMPK topics in internal and external meetings, Health Authority consultations etc. Provide an integrative PK and immunogenicity assessment to put PK studies into the context of the projects Responsible for the nonclinical and clinical PK and immunogenicity testing strategy May provide TK assessments for exploratory and regulatory safety studies May act as monitor for the outsourced studies within the given project and the given area of expertise Ensure the quality of the outsourced studies and that the generated data/reports meet the applicable international regulatory requirements May provide support for the external opportunity evaluations Manage study timelines and objectives of outsourced studies Oversee the budget for outsourced/internal studies Ensure that the appropriate budget and resources are allocated in PIMS for the development projects
University degree in a pharmacokinetic/chemical-biological field or equivalent training including Ph.D. At least 5 years of professional experience Excellent knowledge of drug development and discovery processes Excellent knowledge of DMPK, related to scientific matters Excellent knowledge of NBE work packages (nonclinical and clinical) General knowledge of the disease area and more in-depth understanding of biology/pharmacology Excellent knowledge of the regulatory requirements Good knowledge of immunogenicity Good understanding of translational sciences (Modeling & Simulation)
External website http://www.merck.de/de/karriere/globale_stellensuche/globale_stellensuche/jobsearch/job-1300150/DMPK
5th Mar 2013 [2363]
DMPK Modeling & Simulation Expert (m/f)
As DMPK Modeling and Simulation Expert (m/f) your key tasks and responsibilities comprise the following:
Contributing to the non-clinical M&S section of regulatory documents and documents used for internal decision making (e.g. DPO Report, Investigator Brochure, IMPD, IND) Integrating knowledge about PK and PD properties of new molecules to support the selection of new compounds Performing more complex human PK predictions and integrating pharmacological data to predict the efficacious human dose and dose scheduling Performing quantitative DDI prediction by applying appropriate models considering the stage of the molecules Ensuring that adequate support for M&S topics in internal and external meetings, HA consultations etc. will be provided to the NCS-L and to the project representatives Ensuring that M&S issues will be discussed appropriately within the function and an agreed position is reached before giving feedback outside the function May acting as an ad hoc member to DPTs, NCS-teams and GPTs Evaluating and implementing new approaches and techniques for M&S May providing TK assessments for exploratory and regulatory safety studies May acting as monitor for studies outsourced within the given project and the given area of expertise Ensuring the quality of outsourced studies and that generated data/reports meet applicable international regulatory requirements May providing support for external opportunity evaluations Managing study timelines and objectives of outsourced studies
University degree in Pharmacokinetic or chemical-biological fields or an equivalent training including Ph.D. Fluent spoken and written English Proficient in communication with impact High managerial skills Good intercultural understanding Strong mature leadership and influencing skills
External website http://www.merckgroup.com/en/careers/global_job_search/global_job_search/jobsearch/job-1204849/DMPK_
Contact email address: jens.quant@boehringer-ingelheim.com - 5th Mar 2013 [2362]
Boehringer Ingelheim RCV Vienna is home to Boehringer Ingelheim’s dedicated drug discovery center for innovative cancer medicines. A team of more than 200 scientists and technicians, with combined expertise in cancer biology and genomics, pharmacology, medicinal chemistry, structural research, high-throughput screening and Discovery ADME, drive our efforts to identify and profile novel oncology drugs. In our Department of Discovery ADME we are looking for a Laboratory Head Pharmacokinetics /Pharmacodynamics.
Your responsibilities:
- Support projects with state-of-the-art PK/PD expertise
- Drive PK/PD approaches in oncology research
- Identify project specific PK and PD parameters to utilize PK/PD modeling optimally
- Interact with all project teams as main PK/PD expert
- Incorporate new methodology as needed to achieve research goals
- Representative of Department in selected project teams to drive and coordinate all ADME/PK related topics (in-vitro, in-vivo, physchem, formulations)
- Interaction with other experts to integrate best project support from all disciplines
- Managing the lab resources in relation to the departmental resources
- Supervision and development of technical staff
Your qualifications:
- PhD in Chemistry, Biology or Pharmaceutics
- Ideally 1-2 years of academic postdoctoral experience in a relevant area
- Solid experience in quantitative PK/PD
- Ability to identify chances offered by new methods and techniques to increase the efficiency and effectiveness of your laboratory
- Interdisciplinary thinking and open communication
- Industrial experience is a plus
External website http://jobs.boehringer-ingelheim.at/boeviejob.php
4th Mar 2013 [2360]
Join AstraZeneca as a Senior Clinical Pharmacometrician, and you’ll use innovative pharmacometric modelling methods to make decisions that are critical to the future of our business. You’ll be responsible for integrating emerging clinical data with our existing preclinical models, and making sure appropriate feedback is provided. The potential scope is huge – and with innovative new technologies emerging constantly, there’s never been a better time to come aboard.
AstraZeneca – Health Connects Us All
As one of the world's leading pharmaceutical companies, our business is focused on providing innovative, effective medicines that make a real difference in important areas of healthcare. At AstraZeneca, innovation is about more than just research. We aim to stimulate continued creativity throughout our organisation by maintaining a culture in which our people feel valued, energised and rewarded for their ideas and contribution to our success - ideas which can make a difference in all aspects of our business. And we support and encourage our people in discovering their own potential, through excellent learning and development opportunities that are available to them throughout their careers.
As a Senior Clinical Pharmacometrician your skills and qualifications will ideally include:
- A degree-level education (or equivalent)
- Demonstrated expertise in pharmacometrics
- Experience of mechanistic modelling, systems pharmacology, quantitative translational scaling, literature meta-analyses and population modelling
- A track record of contributing to the pharmacometric aspects of clinical drug development
- A high level of proficiency with pharmacometric and statistical software tools
- Interpreting data and reporting results
- Creating pre-clinical, clinical, and post-approval development plans
- Using emerging clinical data to establish a model continuum
- Evaluating new data analysis techniques and software, then integrating them into existing working practices
- Presenting results at scientific meetings and in front of regulatory authorities
We’ll need to see extensive experience gained in a variety of disciplines, including pharmacology, pharmaceutical sciences, biostatistics, medicine, mathematics, physiology or engineering.
External website http://gs.globalsuccessor.com/fe/tpl_astrazenecav2.asp?newms=jj&id=59262&----JOB-PREVIEW-MODE----
Contact email address: fran@stelfoxuk.com - 26th Feb 2013 [2358]
Senior Principal Scientist Pharmacokinetics NBE, Germany
This is an exciting opportunity for an experienced Pharmacokineticist to join a market leading and innovative global pharmaceutical company. This position is based in the South of Germany.
In this challenging role will:
- Contribute to the selection and characterisation of new biological entities whilst acting as Nonclinical PK project lead in multifunctional teams
- Use innovation and a broad scientific knowledge to develop project strategy in regard to expected human PK and PD
- Integrate PK and bioanalytical data
- Make significant contributions to local and international research and early development teams
- A PhD degree in a relevant science and significant hands-on experience in pharmacokinetics
- Proven Pharmaceutical industry experience in Pharmacokinetics spanning at least 7 years
- Practical exposure to compartmental and non-compartmental data analysis
- In depth experience in characterising new biological entities
- Practical experience with modelling and simulation tools
- Excellent communication skills in English. German language skills highly beneficial
- A dynamic and innovative working environment at a research-focused pharmaceutical company
- A competitive package including relocation assistance
- Fantastic opportunities for personal development
Contact Francesca at +44 1273 727 930 or fran@stelfoxuk.com
Francesca is a Research & Development Search expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia.
External website http://stelfox.broadbeantech.com/
Contact email address: fran@stelfoxuk.com - 26th Feb 2013 [2357]
Principal Scientist Pharmacokinetics NBE, Germany
This is an exciting opportunity for an experienced Pharmacokineticist to join a market leading and innovative global pharmaceutical company. This position is based in the South of Germany.
In this challenging role will:
- Contribute to the selection and characterisation of new biological entities whilst acting as Nonclinical PK project lead in multifunctional teams
- Use innovation and a broad scientific knowledge to develop project strategy in regard to expected human PK and PD
- Integrate PK and bioanalytical data
- Make significant contributions to local and international research and early development teams
- A PhD degree in a relevant science and significant hands-on experience in pharmacokinetics
- Proven Pharmaceutical industry experience in Pharmacokinetics spanning at least 5 years
- Practical exposure to compartmental and non-compartmental data analysis
- In depth experience in characterising new biological entities
- Practical experience with modelling and simulation tools
- Excellent communication skills in English. German language skills highly beneficial
- A dynamic and innovative working environment at a research-focused pharmaceutical company
- A competitive package including relocation assistance
- Fantastic opportunities for personal development
Contact Francesca at +44 1273 727 930 or fran@stelfoxuk.com
Francesca is a Research & Development Search expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia.
External website http://stelfox.broadbeantech.com/
Contact email address: fran@stelfoxuk.com - 26th Feb 2013 [2356]
Senior Scientist Pharmacokinetics NBE, Germany
This is an exciting opportunity for an experienced Pharmacokineticist to join a market leading and innovative global pharmaceutical company. This position is based in the South of Germany.
In this challenging role will:
- Contribute to the selection and characterisation of new biological entities whilst acting as Nonclinical PK project lead in multifunctional teams
- Use innovation and a broad scientific knowledge to develop project strategy in regard to expected human PK and PD
- Integrate PK and bioanalytical data
- Make significant contributions to local and international research and early development teams
- A PhD degree in a relevant science and significant hands-on experience in pharmacokinetics
- Proven post-doctoral experience in Pharmacokinetics spanning at least 3 years
- Practical exposure to compartmental and non-compartmental data analysis
- In depth experience in characterising new biological entities
- Practical experience with modelling and simulation tools
- Excellent communication skills in English. German language skills highly beneficial
- A dynamic and innovative working environment at a research-focused pharmaceutical company
- A competitive package including relocation assistance
- Fantastic opportunities for personal development
Contact Francesca at +44 1273 727 930 or fran@stelfoxuk.com
Francesca is a Research & Development Search expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia.
External website http://stelfox.broadbeantech.com/
Contact email address: shahr10@gene.com - 25th Feb 2013 [2355]
The Clinical Pharmacology Department at Genentech, Inc. is seeking a Ph.D. level Senior Scientist who is driven to understand the clinical pharmacokinetics and pharmacodynamics of novel drug candidates in the area of Oncology. This individual will be responsible for the clinical PKPD activities of Biologics, Antibody Drug Conjugates and/or Small Molecules in clinical development. This person will have responsibility for the Clinical Pharmacology strategy in order to ensure that appropriate dose/route/schedule decisions are made using the state of the art modeling and simulation strategies that are aligned with project needs. This will be accomplished by working in close partnership with Clinicians, Biostatisticians, Clinicians and project teams. Responsibilities will include planning and reviewing study designs, analysis plans, data analysis, interpretation of PK/PD as well as planning, implementation and organization of regulatory filings (worldwide) and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings (worldwide). Additionally this individual will also be directly involved in leading project sub-teams and representing the function at cross-functional project teams. Relevant experience and demonstrated impact on drug development is expected and experience with Biologics is highly desired. In addition, experience in the preparation of regulatory interactions and good knowledge of GCP and regulatory guidelines is highly desirable. Leadership abilities are a plus.
The candidate must have excellent communication skills, the ability to work independently and the ability to work effectively on interdepartmental project teams. Familiarity with quantitative approaches in drug development, working knowledge of modeling software (NONMEM, ADAPT II and WinNonlin) and the ability to plan, organize, and critically assess and/or perform PK/PD data analyses are essential
A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline with >10 yrs years of industry and/or related post-doctoral Clinical Pharmacology experience are required
External website http://www.gene.com/careers
Contact email address: cwto@novonordisk.com - 23rd Feb 2013 [2354]
Temporary Modelling Scientist Position available at Novo Nordisk A/S
Do you want to conduct PK/PD and exposure-response analyses to support the development of new drugs at Novo Nordisk in a one year temporary position?
About the department: The Quantitative Clinical Pharmacology department supports the entire Novo Nordisk development portfolio with model-based analyses from first in human studies to registration. You will be part of a diverse team of dedicated modelling and clinical pharmacology scientists in our R&D Global Development organisation.
The Job:
As Modelling Scientist you will have an important role in the development of new drugs at Novo Nordisk, taking part in designing, analysing, interpreting, communicating and reporting quantitative clinical pharmacology information (e.g. population PK/PD and exposure-response analyses) at all stages of clinical drug development. You will be part of multidisciplinary project teams where you will be responsible for developing modelling analysis plans for the project and follow them to completion.
Qualifications:
You hold a university degree in a relevant area (Statistics, Engineering, Pharmacy or other), preferably with a supplementary Ph.D. You are fluent in English both orally and written. You have a strong background in pharmacokinetics, statistics and/or quantitative clinical pharmacology analyses and have hands-on experience using S-PLUS/R and/or NONMEM. You are innovative with a high degree of independence, result and quality oriented, and thrive in a continuously changing environment with tight deadlines. You appreciate an informal atmosphere and act as a dedicated team player. As your colleagues will have different academic backgrounds, good presentation, communication and negotiation skills are essential.
At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.
Contact: For further information, please contact Christoffer Wenzel Tornøe at +45 3075 8193.
Deadline: 17 March 2013.
External website http://novonordisk.com/careers/job_section/current_jobs.asp?jobid=12436BR&lCountry=
Contact email address: broseberry@cartermackay.com - 21st Feb 2013 [2353]
Associate Director, Pharmacology (United States)
seeking a PhD with 7+ years experience in developing in vivo and in vitro models for compound screening. Will investigate mechanism of action and support clinical results for efficacy. review study design and evaluate data from in vivo and in vitro nonclinical pharmacology studies. Will also be expected to identify pharmacological effects that may produce AE in clinical trials. Must have experience in nonclinical sections of NDA\\\'s and IND\\\'s. Will extrapolate data from preclinical to human dose projection and review clinical protocols up to phase II, as well as PK, drug interaction, and ADME. Will attend meetings with FDA and present research findings at meetings and conferences. Great opportunity with an established pharma client. please send resumes or questions to broseberry@cartermackay.com
19th Feb 2013 [2352]
Shire is currently seeking a Sr Director of Pharmacokinetics to join our Clinical Pharmacology team in supporting drug development project teams across all therapeutic areas and all stages of Development. You will also provide clinical PK/PD expertise to support the development, registration and commercialization of Shire’s products from before first-in-human studies and throughout the product lifecycle.
You will have an excellent track record in a similar position within either a pharmaceutical company or a CRO.
You will design clinical pharmacology/PK programs to support the development, registration and commercialization of Shire’s products and ensure programs comply with regulatory authority and legal requirements.
You will collaborate internally and externally as necessary to agree programs of work and budgets.
You will use your expertise to select suitable Contract Research Organisations (CROs) and academic centers to carry out programs of work and to establish collaborations with key consultants. You will also be responsible for the ongoing monitoring of those partners.
You will agree on detailed study protocols with contractors and monitor programs of work to ensure compliance with agreed protocols, quality standards and timelines as well as review data in a timely manner and amend protocols as necessary to achieve best outcome.
Together with the study team, you will be responsible for ensuring a high quality report, suitable for regulatory submission, is produced for each study and involve other internal and external specialists as necessary to interpret findings and assess relevance for use in man.
You will provide clinical PK and human drug metabolism expertise to Project Teams and Shire management across projects.
You will provide the clinical pharmacokinetics and pharmacodynamics expertise and support required for preparation of Investigator Brochures, Clinical Trials Applications, Marketing Applications, regulatory meetings, and responses to regulatory questions. You will agree the clinical pharmacology documentation plan for each submission, including timelines and how the work is to be resourced, with the Project Team and VP Clinical Pharmacology
EDUCATION & EXPERIENCE REQUIREMENTS:
- A PharmD or PhD from an accredited college or university in clinical pharmacology, pharmaceutics, clinical pharmacokinetics or biopharmaceutics or closely related field.
- Extensive experience in the Pharmaceutical Industry working in clinical pharmacology, clinical pharmacokinetics or drug metabolism.
If you wish to apply for this position, please send your C.V. to: Peter Murphy, Internal Recruiter, Shire Pharmaceuticals, Chineham, Basingstoke, Hampshire, RG24 8EP. (e-mail: pmurphy-c@shire.com; Tel: +44-(0)1256- 894076; Fax: +44-(0)1256- 894718)
19th Feb 2013 [2351]
The TI Pharma Mechanism-Based PKPD Modeling Platform is a public-private partnership focused on the development of a mechanism-based PKPD and Systems Pharmacology models for rational drug discovery and development. After completion of the successful first phase, the platform is now entering the second phase of 5 years. PKPD platform 2.0 comprises of 7 Academic and Industrial partners and is coordinated by the Leiden Academic Centre for Drug Research (LACDR) at Leiden University (The Netherlands). There are now several positions available for postdoctoral fellows. Key requirements are a strong background in advanced mathematical and statistical modeling and data analysis (ideally with experience of application in biomedical sciences), a track record of scientific innovation and a real desire to be at the forefront of the development of novel concepts in translational PKPD the emerging discipline of Systems Pharmacology. For more information, contact j.p.poels@lacdr.leidenuniv.nl
Contact email address: yjeong@uic.edu - 15th Feb 2013 [2350]
The Department of Pharmacy Practice at the University of Illinois at Chicago is seeking a postdoctoral research associate to work on a preclinical drug development project. A PhD degree in drug metabolism and pharmacokinetics (or related field) and experience in analytical chemistry (HPLC/mass spectrometry) are required. The project involves experiments in the areas of preclinical pharmacokinetics: drug metabolism in microsomes and hepatocytes, metabolite identification, plasma protein binding, CYP induction/inhibition, and in vivo pharmacokinetic studies in mice and rats. The candidate will also have an opportunity to get involved in different projects in Jeong lab (http://openwetware.org/wiki/Jeong_lab). For fullest consideration, applicants should send a CV and a list of three references by March 31, 2013 to: Young Jeong at yjeong@uic.edu.
External website http://openwetware.org/wiki/Jeong_lab
14th Feb 2013 [2349]
The role: Associate Director/Director Clinical Pharmacometrician - AstraZeneca - Wilmington, DE
This is a scientific role within our Clinical Pharmacology & Pharmacometrics group which is involved in candidate drug (CD) selection and in all clinical phases of the product development including registration and commercialization. We are looking for an individual to fill the role of a Director/ Associate Director in the US.
In the implementation of Model Based Drug Development (MBDD), the Director will work closely together with other modeling skills (such as preclinical PKPD scientists, statistical modelers etc ) to develop MBDD plans for disease area related as well as compound related modeling. The Director will develop pharmaco-statistical models including disease models, exposure response models, biomarker - efficacy models etc. The Director will work as a partner in multi-disciplinary development teams by providing MBDD expertise.
The Director will, together with statisticians, have the overall accountability for the MBDD plan. We will also look to this individual to collaborate externally by publishing their work, building relationships with academic institutions and building their expertise by networking with individuals in the pharmacometric field. Individuals in the senior role will also be called upon to coach less senior staff in their modeling work.
Minimum experience
For the Associate Director role, candidates will have a doctorate degree (preferred) but a Master\'s degree and other relevant academic training is acceptable. Candidates should have demonstrated expertise in pharmacometrics (PM) and strong quantitative skills (e.g. experience in mechanistic modeling/systems pharmacology, quantitative translational scaling, literature meta-analyses, population modeling)
For the Director role, a doctorate degree with demonstrated expertise in pharmacometrics and strong quantitative skills (e.g. experience in mechanistic modeling/systems pharmacology, quantitative translational scaling, literature meta-analyses, population modeling) is required. The Director\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\'s experience (>10 years) may have been gained in a variety disciplines including pharmacology, pharmaceutical sciences, biostatistics, medicine, mathematics, physiology, or engineering.. A minimum of 5 years pharmaceutical industry experience, specifically contributing to pharmacometrics aspects of clinical drug development, is essential. As is an in-depth knowledge of advanced PK and PK/PD, a proficiency with pharmacometric/statistical software tools such as NONMEM, R, SAS, S-Plus, Matlab, Berkeley Madonna, a knowledge of FDA/ICH requirements for drug registration, knowledge of Bayesian methods and Monte-Carlo simulation, PK and PD drug interactions, in vivo/in vitro models, biopharmaceutics and the ability to understand, and implement all aspects of pharmacometrics needs across a variety of disease areas.
External website http://jobs.astrazeneca.com/jobs/22159
Contact email address: nolin@pitt.edu - 13th Feb 2013 [2348]
UNIV OF PITTSBURGH SEEKING PHARMACOMETRICS FACULTY MEMBER
The University of Pittsburgh School of Pharmacy (Pittsburgh, PA, USA) is seeking a highly motivated, innovative, and dedicated faculty member with expertise in pharmacometrics, including clinical pharmacokinetic/pharmacodynamic modeling, population pharmacokinetic modeling or modeling and simulation of clinical trials. Individuals focused on the application of quantitative pharmacology or pharmacometric concepts and techniques to therapeutics will have preference. The candidate must be an investigator with demonstrated training, interest and commitment to pharmacometrics research or its application. This non-tenure position is at the Assistant, Associate, or Professor level, commensurate with experience.
Interested individuals should submit inquiries to Tom Nolin at TEL 1-412-624-4683 or Email nolin@pitt.edu
The University of Pittsburgh is an Affirmative Action, Equal Opportunity Employer.
12th Feb 2013 [2347]
Principal Scientist - PK/PD Modeling & Simulation (Oncology)- AstraZeneca - Waltham, MA
At AstraZeneca, our aim is to tackle illness and disease as effectively as possible. Through our R&D pipeline of life-changing medicines, we\\\'re able to offer hope to millions around the world. And innovation is essential to our job. Our strategy includes a substantial application of Predictive Sciences, which help us to deliver drugs that tackle illness and disease even more effectively. The model-based approach is applied to the whole drug development process, and this includes developing a quantitative understanding of the biological hypothesis of drug action on the disease target. An understanding of pre-clinical quantitative pharmacology underpins our human predictions of dose, dose schedule, and therapeutic index and these predictions are critical to drug projects.
The Oncology Innovative Medicines unit (iMED) has an exciting opportunity for an experienced Modeling and Simulation (M&S) scientist to join a vibrant global team. The individual will be embedded into the Oncology research group, working closely with scientists in Biology, Translation, Safety and other modelers. The successful candidate will have excellent problem solving, organizational, and documentation skills, in addition to strong oral and written communication skills. This role requires the ability to thrive in a team-based, multidisciplinary, fast-paced research environment.
Minimum Requirements:
* PhD or equivalent degree in a discipline with a significant component of Modeling & Simulation, such as systems biology, quantitative pharmacology, pharmacometrics, chemical engineering, physics, or applied mathematics, with at least 5 years of relevant industry experience in Modeling & Simulation, ideally in preclinical/translational setting, or an MS degree with at least 10 years of relevant industry experience. * Experience in project-facing role at pharmaceutical R&D. * Comprehensive understanding of DMPK and pharmacology/safety aspects of drug discovery and development. * Track record of supporting PK, PKPD and TKPD aspects of projects, with a delivery focus and ability to meet timelines to pre-specified quality and cost. * Specialist in tools such as WinNonLin/Phoenix NLME, NonMem, Berkeley Madonna, MATLAB, and SimCYP * Experience in project-facing role at pharmaceutical R&D. * Comprehensive understanding of DMPK and pharmacology/safety aspects of drug discovery and development. * Track record of supporting PK, PKPD and TKPD aspects of projects, with a delivery focus and ability to meet timelines to pre-specified quality and cost. * Specialist in tools such as WinNonLin/Phoenix NLME, NonMem, Berkeley Madonna, MATLAB, and SimCYP.
External website http://www.candidatecare.com/srccsh/RTI.home?r=2000019435810&d=astrazeneca.candidatecare.com
Contact email address: broseberry@cartermackay.com - 4th Feb 2013 [2345]
Director, In Vivo Pharmacology--CNS/Pain--northeast US location.
Seeking a PhD with 10+ years experience in in vivo pharmacology, specifcally in the area of discovery through IND. Majority of focus will be on pain models and the evaluation of chemical properties, PK, and ADME information. Will work in multiple cross functional teams and lead a group of pharmacology scientists. Will be expected to support team objectives and bring a full understanding of the scientific basis of pharmacology experiments to project teams. Must have experience in evaluating, establishing, and managing successful drug discovery projects as well as moving compounds into development candidates. If interested, and for more information, send CV/inquiries to broseberry@cartermackay.com
Contact email address: info@greylock-recruiting.com - 4th Feb 2013 [2344]
We are currently seeking a leader to head nonclinical PK/PD for large molecules (and a few small molecules). The incumbent should possess the following:
- at least 10 years of experience in supporting nonclinical PK/PD discovery and toxicology studies
- significant experience with large molecules; experience with small molecules desirable
- experience with managing people
- experience with writing nonclinical sections of IND
- experience in writing nonclinical sections of NDA desirable
- experience in doing PK/PD modeling/assessments desirable
- This is a new position in a growing company that is expanding rapidly.
- A PhD is required for this position.
External website http://www.greylock-recruiting.com
31st Jan 2013 [2341]
COMPANY: Founded in 1974, Apotex Inc. is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 6,800 people in research, development, manufacturing and distribution facilities world-wide.
POSITION: Scientific Leader (Supervisor), Pharmacokinetics
LOCATION: Toronto, ON Canada
JOB SUMMARY: Reporting to and working with the Manager, Pharmacokinetics, the Scientific Leader, Pharmacokinetics is responsible for the management of work and supervising the operation of the Pharmacokinetics department. In this role, the incumbent interacts cross-functionally with other management members within the BioClinical Development Division to ensure that all biostudy projects and related work is properly planned and managed. The incumbent ensures that departmental administration and work is properly assigned and completed, and that all work is conducted in full compliance with established Apotex Inc. Policies, Standard Operating Procedures and relevant Regulatory Guidance(s). In addition, the Scientific Leader, Pharmacokinetics is working together with the Manager, Pharmacokinetics on recruitment, hiring and , coaching of the departmental staff, and is directly responsible for performance management of the relevant employees in the Pharmacokinetics Department.
EDUCATIONAL REQUIREMENTS/EXPERIENCE:
- M.Sc. or Ph.D. in Pharmacokinetics /pharmacology/ Pharmacy / Pharmaceutical Sciences
- 2 years experience in supervising high-level scientific personnel
- At least 3 years of experience in the area of bioequivalence and pharmacokinetics.
- At least 2 years of industry experience in developing protocols and preparing reports for regulatory submissions.
- Previous experience in design of clinical trials and interpretation of the results is an asset.
External website http://https://careersen-apotex.icims.com/jobs/2511/job
29th Jan 2013 [2340]
Put your passion to work at Seattle Genetics
The strength of the Seattle Genetics team resides in our collective commitment to patient care, individual excellence and teamwork.
Pharmacokineticist/Sr. Pharmacokineticist Location: Bothell, Washington Job Code: 1301TH-01
Description Seattle Genetics is seeking a bright and motivated pharmacokineticist to join our Clinical Pharmacology Department
Responsibilities
- Advance the science of novel antibody-based drug candidates through the design, analysis, and interpretation of clinical pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) studies.
- Aid in the development of novel drug candidates by preparing PK, PK/PD, popPK, and/or modeling and simulation components of study protocols, reports, project summaries, development plans, and regulatory submissions.
- Collaborate with drug development teams by serving as a key contact for PK and PK/PD related issues and providing the PK and PK/PD perspective of drug candidates.
Requirements
- Advanced degree (Ph.D., Pharm. D., and/or M.D.) in Biomedical, Biological or Pharmaceutical Science/Engineering with 1 - 4 years of industry experience.
- In depth knowledge of PK and PK/PD concepts with a strong clinical pharmacology background.
- Proficiency in PK and PK/PD analysis using WinNonLin or equivalent software is a pre-requisite.
- Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting.
- Previous experience with monoclonal antibodies.
- Experience with population PK/PD analysis using NONMEM or equivalent software.
- Experience in oncology drug development
- Knowledge of regulatory requirements and experience in communications with regulatory authorities.
Seattle Genetics is an equal opportunity employer.
If you are interested, please apply through the Seattle Genetics website:
http://ch.tbe.taleo.net/CH09/ats/careers/requisition.jsp?org=SEAGEN&cws=1&rid=1148
External website http://ch.tbe.taleo.net/CH09/ats/careers/requisition.jsp?org=SEAGEN&cws=1&rid=1148
Contact email address: broseberry@cartermackay.com - 22nd Jan 2013 [2339]
Pharmacometrician opening--Associate Director level--contact broseberry@cartermackay.com
Summary of Responsibilities
- will collaborate with the PK/PD group in preparation of pharmacometrics sections of clinical protocols and study reports as well as NDA/BLA documents
- Guidance and oversight of outsourced M&S studies
- Will perform population PK/PD modeling and simulations using industry standard tools such as NONMEM.
- Will Work to develop/apply model based drug development strategies to optimize study parameters, dose regimen, etc.
- Participate and advise on project teams on dosing strategy and PK/PD sampling strategy
- collaborate across areas of drug development
- Must have a PhD with 4-10 years experience in related field and strong quantitative skills.
- Must have hands on popPK with NONMEM, as well as the ability to use either SAS or R.
- Experience in working effectively in project teams as well as on relevant sections of regulatory documents.
Contact email address: telder@greylock-recruiting.com - 14th Jan 2013 [2338]
UNITED STATES OPPORTUNITY! We are working on an Associate Director or Director of Pharmacometrics located in the US! If you have experience with NONMEM, population PK, NDA/BLA experience, experience at a CRO is a big plus. Let us know! This exciting opportunity is with a well establshed pharma company that has one of the strongest PK/Clin Pharm teams in the industry. Be a part of it!
External website http://www.greylock-recruiting.com
10th Jan 2013 [2337]
Company: Sanofi, Boston Hub Associate Director, Clinical Pharmacokinetics
The Associate Director, Clinical Pharmacokinetics will provide strong scientific leadership within the Drug Metabolism and Pharmacokinetics (DMPK) function in support of the portfolio of the Sanofi Boston R&D Hub.
In this role the Associate Director will serve as a primary source of scientific support for the design, analysis, reporting, and presentation of pharmacokinetic and pharmacodynamic modeling and simulation initiatives. The individual will be supporting early development by providing pharmacokinetic support and representing the DMPK organization on integrated project teams across preclinical and clinical development through proof of concept. Responsibilities will include prediction of human dose, pharmacokinetics and therapeutic window to support development decision making and first in human clinical trials. The individual will collaborate with the clinical team to design pharmacokinetic components in various clinical study designs including first-in-human and drug-drug interaction studies. In addition, the individual will contribute to pharmacokinetic analysis, interpretation and reporting of pharmacokinetic results from clinical trials, and will support a quantitative model-based drug development approach.
Qualifications Requirements
- A Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related field with a specific focus on pharmacokinetics
- At least 8 years pharmaceutical industry experience in the conduct of clinical pharmacokinetic support
- Proficiency with WinNonLin/Phoenix is required; and hands-on experience with other applicable software applications (e.g., NONMEM, SAS, GastroPlus, Symcyp) strongly desired
- Experience as a team member representing the DMPK function on interdisciplinary project teams
- Strong written, presentation and verbal communication skills are essential
- Experience in preparing reports appropriate for regulatory submission and authoring the relevant components of regulatory documents
External website http://www.genzyme.com/Careers/Job-Search.aspx
Contact email address: jon.gibbs@parexel.com - 7th Jan 2013 [2336]
Company: PAREXEL Job Title: Principal Pharmacokinetic Scientist Department: Scientific Services – Clinical PK/PD and Pharmacometrics Location: UK, Uxbridge Essential Function Primary role of the PK Scientist
- Provision of support to clinical study design and the analysis and interpretation of PK and PD data for Early Phase studies.
- Provide consultative support for PK data interpretation to other SBUs and clients Key Accountabilities:
- To analyze clinical PK/PD data as a member of several multidisciplinary development program teams.
- To work with our clinical team to design PK components in various study designs such as first-in-human, bioequivalence and drug-drug interaction studies. The selected individual will be responsible for authoring or contributing to clinical PK/PD sections of relevant documents.
- Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of sophisticated pharmacokinetic and pharmacodynamic modeling and simulation initiatives, including population pharmacokinetic/pharmacodynamic analyses for both phase I and late phase clinical trials
- To provide training and scientific support and advice to all Early Phase staff
- Review of scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports
- Quality control of pharmacokinetic output from WinNonlin analysis
- Review of derived PK data generated by PK Analyst
- To attend client meetings and represent PK/PD aspects as needed
- Strong Knowledge of drug pharmacokinetics
- Experience in Pharsight Software (WinNonlin/Phoenix)
- Understanding of pharmacokinetic, and PK/PD modeling strategies
- Experience in other software such as NONMEM, S-PLUS (population pharmacokinetics)
- Experience in early clinical drug development of both NCEs and biologicals
- Science degree or preferably higher scientific qualification Language Skills
- Good standard of written and spoken English Desired Work Experience
- 5+ years in Clinical Pharmacology, 5+ years pharmacokinetics experience.
External website http://sh.webhire.com/servlet/av/jd?ai=206&ji=2641743&sn=I
Contact email address: fairmand@medimmune.com - 21st Dec 2012 [2334]
MedImmune is looking to expand its predictive science group and is recruiting a Clinical Pharmacokineticist in its Cambridge UK facility.
Reporting to David Fairman within Balaji Agoram\\\'s Clinical pharmacology and DMPK department the Clinical Pharmacokineticist will be responsible for all aspects of PK/PD-related support for bio therapeutic products.
The Clinical Pharmacokineticist functions as the Global Clinical Pharmacology and DMPK project leader and team representative for biotherapeutic projects at all stages of research and development - from discovery through to BLA.
The scientist will be responsible for all aspects of PK/PD-related support for bio therapeutic products, including design of preclinical and clinical studies, modeling and simulation analysis, trial simulation, and reporting (including GLP data) and communication of data in regulatory documents and meetings.
The successful candidate\\\'s previous experience will include:
Strong PK/PD experience in the execution and application of modeling and simulation is essential. Preferably within an industrial setting but a highly relevant academic lab will be considered. Demonstrate a strong understanding of the drug development process. Evidence of leading study designs in collaboration with clinical or preclinical colleagues would be a significant advantage. Modeling and simulation experience including utilization of packages such as NONMEM, Berkeley Madonna, S-plus and Matlab. Demonstrable team working skills with a track record of delivery and communication of high quality modelling output.
Education: Your experience will be built on a BSc or equivalent as minimum with MSc or PhD in a relevant field preferred
Please see the link for full description and application details.
External website http://www.candidatecare.com/srccsh/RTI.home?r=2000018146110&d=medimmune.candidatecare.com
Contact email address: mohammed.ullah@roche.com - 14th Dec 2012 [2333]
Scientist Drug Transport - Roche
The Position: This challenging position within Early and investigative Drug Dispositions and Safety (EiDDS) includes the following responsibilities:
Provide support to discovery and development projects to elucidate drug transporter processes related to oral absorption, tissue distribution, renal and biliary elimination, as well as the potential for transporter-related drug-drug interactions Responsibility for the design and conduct of tailored in-vitro drug transport studies with technical support of other co-workers within the same group to assess new chemical entities for their potential as substrates or inhibitors of different drug transport proteins Data evaluation, all study-related documentation, communication, and data reporting in regulatory reports or other documents Keeping up to date on the latest developments in the area of drug transport; development of new, innovative in-vitro tools and methods to address questions related to drug safety and relevant for clinical candidate selection; publication of results is highly encouraged Maintain open channels of communication with other disciplines such as screening, enzymology, drug metabolism and bioanalytics. There will also be a need to collaborate with partner groups within NCS, such as discovery and development project leaders, modeling and simulation and clinical pharmacology, supporting/addressing questions with respect to drug transport
Who you are: You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point. Your qualifications will include: PhD or equivalent in pharmacy, biology or a related field with post-doctoral training or previous relevant experience in the pharmaceutical or biotech industry (3-5 years) In-depth knowledge of and practical experience with drug transport proteins in the context of drug research and development; strong background in cell biology and practical experience with cell-based assays Knowledge of pharmacokinetics is an asset High motivation and commitment to work in a team; strive to develop into new areas and expand your existing capabilities; flexible, efficient and used to deliver on tight time lines. Familiarity with standard hard- and software (Windows, Office, and software data evaluation applications), electronic sample management applications, literature searches and kinetic evaluation are expected Excellent command of written and spoken English is required
External website http://careers.roche.com/en/jobs/SWITZERLAND/RESEARCH/2613854356/Scientist-Drug-Transport.html
