KU Leuven invites applications for a full-time tenured academic position in Pharmacometrics at the Department of Pharmaceutical and Pharmacological Sciences. We are looking for a dynamic and motivated individual (m/f) with an excellent research record and extensive experience in this field. The Department of Pharmaceutical and Pharmacological Sciences includes all medicines related disciplines from validation of a target to the safe use of a drug by the patient. While modelling and simulation are currently applied within several research units of the department, there is a clear need for the implementation of expertise and vision in the field of model-based drug development.
External website https://lnkd.in/daEUXJw
Contact email address: broseberry@cartermackay.com - 17th Jan 202 [2979]
Senior Director CLinical Pharmacology (2 roles, one in the bay area and one in MA) inquiries and interest to: broseberry@cartermackay.com
The Senior Director of Clinical Pharmacology is expected to lead a team of clinical pharmacologists and provide technical and strategic leadership on issues related to clinical pharmacology and pharmacokinetics and pharmacodynamics (PK/PD) from the discovery stage up to the post marketing support (PMS) stage. The overall responsibilities include providing Clinical and non-Clinical Pharmacology functional line leadership and oversight in designing and executing, within the regulatory framework, non-clinical DMPK and toxicokinetic (TK) studies during the discovery phase, and FIH, POC, Phase 1 to 4 studies during the clinical development phase for R&D projects. The responsibilities also include managing company’s technical and strategic needs for conducting in-licensing activities. The incumbent is responsible for ensuring Clinical Pharmacology support and is expected to actively participate in the key decisions at the R&D governance milestones. The incumbent is expected to have hands-on knowledge and ability to strategically guide and contribute to model and simulation based quantitative assessments. At the non-clinical stage the incumbent is responsible for providing leadership on key milestones up to IND filing by collaborating with toxicology and biomarker functions to enable selection of dose/regimen for FIH studies for all research programs. At the clinical stage the incumbent is responsible for authoring and strategizing clinical pharmacology development plans, identifying Phase 2/3 dose regimens by collaborating with Pharmacometrics and other disciplines, providing strategic ownership and direction to the authoring and review of protocols, reports and integrated summaries submitted to the regulatory authorities and interacting with the regulatory authorities. The responsibilities also include managing the department resources and budgets at a therapeutic area level. At the enterprise level, the expectation is to provide leadership in functional compliance and cross-functional collaboration on companywide initiatives related to productivity, innovation or efficiency.
Principal Responsibilities
- Provide clinical pharmacology leadership on project team(s) and collaborate across all areas of early development and clinical development functions. Responsible for the preparation of the clinical pharmacology development plan and provide input into the integrated clinical development plan (ICDP)
- Responsible for the preparation of the clinical pharmacology (including bioanalytical) sections of early and late-stage clinical protocols and PK/PD modeling & simulation data-analysis plans
- Contribute to the design of early phase clinical trials (FIH to POC) and ensure that project goals are met
- Accountable for recommending the starting dose in FIH trials based on allometric scaling or physiologically based PK-PD modeling using nonclinical PK/PD data
- Lead assessments of relevant exposure vs. response data for supporting dose selection during and post POC
- Contribute to the design of late-stage clinical trials to ensure that project goals are met
- Lead the recommendation and presentation at the governance meetings for the starting dose in Phase II and III clinical trials based on PK/PD, efficacy and safety data analysis from previous studies.
- Accountable for the pharmacokinetic and PK/PD data analyses using WinNonlin, NONMEM and/or other software for such analyses
- Responsible for the preparation of clinical PK/PD reports and/or clinical PK/PD sections of the CSRs
- Contribute to the preparation of the clinical pharmacology sections of pre-IND, IND, IB, IMPD and other regulatory documents
- Represent the Clinical Pharmacology function at meetings with regulatory agencies
- Conduct clinical pharmacology-based assessment of in-licensing opportunities
- PhD in field related to Pharmacokinetics and 15+ years of industry experience in Drug Development.
- Advanced knowledge of and hands-on experience in the area of PK/PD/Immunogenicity, modeling and simulation and drug development in multiple therapeutic areas.
- Experience across the development phases is a must.
- Extensive experience in developing the strategy & designing, directing & implementing clinical pharmacology plans for compounds, both biologics and small molecules.
- Knowledge of the current practices and issues in the bioanalytical, biopharmaceutics, nonclinical metabolism and pharmacokinetics, safety pharmacology and toxicology areas
- Technical and practical knowledge of global regulations, regulatory guidances, ethical issues associated with clinical studies and drug development SOPs
- Proven track record of successfully delivering regulatory documents (reports, INDs, briefing documents, CTD/MMAs etc.) and representing company at the regulatory agencies, e.g. pre-IND, EOP2, pre-NDA, labeling and advisory committee and/or oral hearing meetings.
- Established track record of leading team(s) of scientists and mentoring direct reports in the area of Clinical Pharmacology.
- Proven record of simultaneously managing and completing multiple complex projects independently and through direct reports.
- Established track record of scoping and executing due diligence activities at all stages of development. Experience in executing strategy and operational aspects of mergers and acquisitions.
- Strong communication, leadership and people interaction skills, while working in a highly matrixed environment. Knowledge of managing departmental budgets and company level multi-year business
Contact email address: telder@stem-sourcing.com - 7th Jan 202 [2978]
Associate/Director, Clinical Pharmacology/Pharmacometrician
The Director, Clinical Pharmacology/Pharmacometrics will join a dedicated team of clinical development professionals and be responsible for all aspects of clinical pharmacology with focus on PKPD, population PKPD and regulatory interactions. They will be instrumental in dose selection and dose optimization efforts through analyses of PKPD data. They will be interfacing with various groups internally and externally with CROs and alliance partners to ensure proper support for programs and studies. The individual in this role will work with minimal supervision and participate in KOL and regulatory meetings. They will provide strategic and scientific direction and be diligent in delivery of key CP project goals. Responsibilities: Lead pharmacometric aspects of clinical development plans across multiple projects. Hands on pharmacometric modeling, including exposure-response, disease modeling, and population modeling. Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of pharmacokinetic and pharmacodynamic results from clinical studies. Contribute to clinical study designs including first-in-human, human mass balance, bioavailability and/or bioequivalence and drug-drug interaction studies. Develop submission ready summaries of modeling results and interpretations for regulatory documents (IND, NDA, IB, etc). Familiarity of FDA and EMA, and ICH guidance documents including GXp regulations on current practices in the areas of POPPK, PKPD, ADME and clinical pharmacology. Responsible for contributing pharmacometric and clinical pharmacology components of regulatory submissions and responses to questions from regulatory agencies. Oversight of M&S CROs and consultant relationships to ensure capacity to respond to program needs at all stages of development Candidate is expected to work independently with minimal supervision. Mentor colleagues in the department. Strong communication, organizational and interpersonal skills, and ability to manage projects and team members in a matrix environment. Basic Qualifications: PhD. in pharmacokinetics or related discipline with 5 to 8 years of relevant industrial experience Experience (1-2 years) demonstrating regulatory submission with NDA and INDs and responses to regulatory clinical pharmacology/pharmacometric questions. Preferred Qualifications: Strong scientific background in pharmacokinetics, pharmacodynamics and drug disposition sciences Experience in population PK, PKPD, M&S utilizing software such as NONMEM, Monolix, R, Gastroplus/Simcyp/PKSim is desirable. Experience working with external vendors and CROs. Problem solving and organizational skills with attention to detail. Strong team player and strong motivational skills.External website https://www.stem-sourcing.com
Contact email address: yingfeili803@msn.com - 12th Dec 201 [2977]
Novartis Analytics Internships 2020
Location: East Hanover, NJ; Cambridge, MA Number of Positions: Multiple Type of Student: Graduate, PhD Deadline for Applying: January 31, 2020
At Novartis, we are reimagining medicine to improve and extend people’s lives. We have one of the most diverse product pipelines in the pharmaceutical industry and performance-driven professionals are bringing innovative medicines to life.
The department of biostatistics and pharmacometrics at Novartis will have multiple internship positions available for approximately 12 weeks in 2020 (May to August; dates flexible).
Job Description:
Interns will work on statistics, pharmacometrics or data science projects to design and analyze clinical trials and/or perform relevant quantitative research under the guidance of experienced quantitative scientists. Various real-world problems will give interns hands-on exposure to the early and late phases of drug development across different therapeutic areas, including oncology, cardiology, immunology, neurology, ophthalmology, and respiratory care. Potential topics include machine learning (e.g. deep learning), survival analyses, causal inference, Bayesian statistics, disease progression modeling, and/or PK/PD modeling. Interns will also attend seminars and other activities to enhance their understanding of the drug development process. There will be opportunities for interns to present their project results to quantitative scientists and other key stakeholders.
Requirement:
Candidates must be enrolled in a graduate – level program working toward a PhD in biostatistics, statistics, pharmacometrics, engineering, mathematics, or a related quantitative discipline and have completed at least 1.5 years of course work. In addition, candidates must be authorized to work in the United States.
Competitive candidates must have the following skills:
- Strong knowledge of R, working knowledge of Rmarkdown, Rshiny and SAS
- Strong background in NONMEM, MONOLIX, Python and/or other software/language
- Strong problem-solving skills
- Excellent oral and written communication skills
10th Dec 201 [2976]
Dear Colleagues,
The Modelling and simulation group at Ablynx, a Sanofi Company, is looking for an experienced pharmacometrician to join our team. The position is based in Ghent, Belgium.
Preferred Background: PhD in PK-PD or Pharmacometrics with Drug Development Experience.
Interested colleagues can apply via the link below https://sanofi.wd3.myworkdayjobs.com/SanofiCareers/job/Gent/ASSOCIATE-PRINCIPAL-SCIENTIST-M-F_R2525439-2
Ablynx, a Sanofi company, is engaged in the development of Nanobodies, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology. www.ablynx.com This position requires substantial experience and expertise, as it will also entail mentoring and guidance of more junior PK/PD modelers and members of collaborating departments. At the project level, the individual will be a member of the translational medicine subteam and in specific cases may lead this subteam and participate on the project core team. The position is located in Belgium.
Responsibilities Main duties
- Participate in designing the early development plan and overall translational medicine and clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the Company.
- Serves as expert in PK/PD matters and modeling concepts and their application to dose selection, study design, risk/benefit, and informing drug development decisions in close collaboration with partners on projects.
- Integrates PK/PD results into regulatory filings and product labels.
- Interacts effectively with managers from various disciplines.
- Influences external environment through publications and presentations. Interactions
- Internal: Discovery, Safety & Toxicology Scientists, clinicians, project leaders, clinical trial managers, bioanalysis scientists, data managers, biostatisticians, representatives from Regulatory Affairs; internal governance bodies.
- External: PK/PD and pharmacometrics KOLs, academic research organizations, external technical and regulatory consultants, health authorities.
- Provides Modeling and Simulation support for the PK/PD characterization of the nanobody platform, to identify ADME factors to consider for optimal nanobody engineering.
Broad expertise is needed to cover project needs from the Discovery phase up to the final marketing application. - Has considerable organizational awareness (inter-relationship of departments, business priorities, etc.).
- Ensures cross-functional cooperation. Excellent communication skills and capacity to adjust the communication style to the audience.
- Ensures high quality documents, requiring strong writing and communication skills.
- Manages aggressive timelines effectively through cross-functional planning. Decision Making Authority
- Sees opportunities for supporting a streamlined and efficient drug development.
- Makes proposals and seeks endorsement for pharmacometrics strategies, is responsible for their execution, and communication to regulatory authorities.
- Advanced degree: M.Sc. or M.Sc./Ph.D with at least 5 years of research experience in industry and/or academia, with focus on clinical and/or translational research.
- Broad knowledge and understanding of pharmacological processes.
- Knowledge of clinical trials from early development to final submission phase.
- Knowledge and mindset in translational research and bridging strategies.
- Strong hands-on modeling and simulation skills (NonMem, R, PKSIM and/or other modelling and simulation softwares).
- Advanced mechanistic PK/PD modeling experience. Preferred Qualifications
- Postgraduate pharmacometrics and/or statistical training.
Contact email address: karley.yeoman@astrazeneca.com - 25th Nov 201 [2974]
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible into reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can change the course of medicine and bring new ideas to life.
As a Clinical/Senior Clinical Pharmacometrician, you will be responsible for population PK, PKPD, exposure-response, disease modelling, and simulations in all clinical development phases in oncology, with special emphasis on biologics . You will have the opportunity to contribute to state-of-the-art modelling and simulation (M&S) approaches. The desired candidate will have strong quantitative skills to influence designs and conduct decision-making at the project level.
Main duties and responsibilities:
- Accountable for expert data integration, analysis, interpretation, and reporting of M&S results within the project level
- Accountable for executing state-of-the-art M&S techniques with value for the project
- Use of M&S to influence study designs and decisions
- Scientific and strategic input into clinical, and post-approval development plans
- Support Biologic License Application in clinical pharmacology dossiers
- Development of mechanistic or empirical PKPD/tumor growth inhibition/time-to-event models to support projects for late-stage oncology assets
- Presentation of M&S results in internal and external forum
- Contribution to internal initiatives to develop the pharmacometric discipline
- Participation in and accountability for peer review of ongoing activities, reports and presentations
- Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidances
- Good knowledge of clinical pharmacology pathways involved in oncology, including the potential role of pharmacodynamic biomarkers to inform M&S approaches
- PhD degree preferred or equivalent (M.Sc./Pharm.D.)
- 3 years of drug development experience, with emphasis on pharmacometrics
- Expert knowledge of pharmacokinetics and Model-Based Drug Development
- Excellent skillset in written and verbal communication
- Demonstrated ability to identify, develop and execute M&S activities
- Knowledge of regulatory, compliance, processes, standards and issues in pharmacometrics
- Oncology disease domain knowledge
- Familiar with PK and statistical softwares such as NONMEM, R, Matlab, Winbugs, SAS, Monolix
- International reputation gained from publishing in pharmacometrics
External website https://astrazeneca.wd3.myworkdayjobs.com/en-US/Careers/job/UK---Cambridge/Clinical-Senior-Clinical--Pharmacometrician_R-065009-1
Contact email address: catia.marzolini@usb.ch - 22nd Nov 201 [2973]
PhD thesis in physiologically based pharmacokinetic modeling of long-acting injectable antiretroviral drugs: Basel, Switzerland
A fully funded PhD position (100%) is available in the Division of Infectious Diseases & Hospital Epidemiology at the University Hospital of Basel. The project aims to develop physiologically based pharmacokinetic (PBPK) models to simulate dosing requirements of long-acting intramuscular antiretroviral drugs in special populations and to manage drug-drug interactions with concurrent medications. The PBPK approach uses in vitro drug data (i.e. physicochemical characteristics, intrinsic clearance, and intestinal permeability) and a mathematical description of drug absorption, distribution, metabolism and elimination (ADME) to predict the pharmacokinetics in a virtual population. This research project is of particular clinical importance, as it will provide guidance on dosing requirements in special populations, which were not evaluated comprehensively during drug development but which may also benefit from this novel treatment paradigm aiming to improve the chances of life-long maintenance of HIV suppression. In addition, this project will provide a comprehensive knowledge of factors influencing intramuscular drug disposition and improve the knowledge on drug-drug interactions with this route of administration.
You are a highly motivated young scientist with an above-average degree (MSc or equivalent) in pharmacy, natural science or mathematics. In addition, you have knowledge about relevant pharmacological concept. Experience in modelling will be an advantage
This position is also open to candidates from the European Union and North America. The working language is English. German skills, although helpful, are not essential. Basel is a highly attractive city with a multinational population.
Application/contact Please send one PDF file including CV with academic transcripts, publications/ presentations at conferences, three academic references as well as a letter of motivation to: Prof. C. Marzolini: catia.marzolini@usb.ch and F. Stader: felix.stader@unibas.ch Applications will be considered until December 31, 2019. The position is available from April 2020.
Please note that there will be no follow-up correspondence for applications that do not fulfill the position requirements.
Contact email address: mehvar@chapman.edu - 19th Nov 201 [2972]
Postdoctoral Research Fellow in Pharmacokinetics/Pharmacodynamics/Drug Metabolism
A Post-doctoral position is available in the Department of Biomedical & Pharmaceutical Sciences at Chapman University School of Pharmacy in Irvine, California. The specific research includes the use of animal models to study the effects of liver diseases on the transporter- and/or cytochrome P450-mediated hepatobiliary and brain disposition of drugs. Candidates with a Ph.D. degree in Pharmaceutical Sciences with interest in the areas of pharmacology/ pharmacokinetics/drug disposition/drug metabolism will be considered. Additionally, the position requires prior experience with surgical procedures in rodents and analytical methods, such as LC/MS/MS, demonstrated by strong peer-reviewed publications. Excellent oral and written communication skills and the ability to work independently or as part of an interdisciplinary team are essential. The successful candidate will work in a new research facility, which is equipped with state-of-the-art research equipment.
Qualified applicants should submit a curriculum vitae, a summary of research interests, and names/titles and contact information of three references electronically to Dr. Reza Mehvar (mehvar@chapman.edu). Review of applications starts immediately and will continue until the position is filled.
Chapman University is an Equal Opportunity Employer, committed to providing career opportunities to all people, without regard to race, color, religion, sex, age, national origin, sexual orientation, disability, or veteran status.
External website https://www.chapman.edu/our-faculty/reza-mehvar
Contact email address: broseberry@cartermackay.com - 7th Nov 201 [2971]
Sr. Scientist PBPK and clinical pharmacology--NJ please email me with interest and questions at broseberry@cartermackay.com The Senior Scientist will collaborate with team members to identify and define mechanisms of action, biomarkers and new drug targets. They will help design clinical pharmacology trials and selecting pharmacokinetic (PK)/pharmacodynamic (PD) /biomarker assessments throughout development, develop physiologically-based pharmacokinetic (PB-PK) models, evaluate new formulations effect on PK. Will conduct PK/PD analysis and reporting, contribute relevant sections to regulatory filings, work with pharmacometricians to develop PK/PD models and contribute to commercial strategies.
Key responsibilities
- Contribute to the development and execution of Clinical Pharmacology strategy for given programs
- Collaborate with clinical development to design and implement early clinical development strategies (first-in-man through pharmacological/biomarker proof of concept Phase Ib/Phase 2a)
- Identify new drug targets and biomarkers
- Provide input to project teams on biopharmaceutics, pharmacogenomics and biomarkers.
- Work on development of physiologically-based pharmacokinetic models
- responsible for the generation of protocol outlines
- Coordinate with bioanalytical scientists on types methods used to support clinical trials.
- Analyzes PK and PD data using non-compartmental and compartmental methods and prepares PK and PD sections of study reports and regulatory submissions documents.
- Partner with pharmacometricians to develop PK/PD/efficacy models.
- represent the PK function at internal and external meetings
- PhD or PharmD
- Minimum of 2-5 years PK/PD experience required (can include postdoc work)
- Able to work with minimal supervision and think independently
- Has demonstrated success in technical proficiency, scientific creativity and collaboration with others.
- Has worked on problems in which analysis of data requires evaluation of identifiable factors
- Solid understanding of clinical pharmacology with knowledge of PK/drug metabolism and human physiology
- Ability to create written summaries and presentations using MS Office (Word, Excel, PowerPoint, Outlook) and Sigma Plot
- Experience with PK/PD software (e.g., WinNonlin) and plotting software (e.g., R, SigmaPlot,
Contact email address: ester.lori@basilea.com - 4th Nov 201 [2970]
Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company, headquartered in the heart of the life sciences hub of Basel, Switzerland. We are an innovative and multinational team of 225 employees worldwide and committed to discovering, developing and bringing to market medicines that make a clear difference to the lives of patients. Our activities are focused on the therapeutic areas of oncology and anti-infectives, with two commercialized drugs in our portfolio (Cresemba(R) and Zevtera(R)).
For our headquarter in Basel we are currently looking for a Senior Clinical Pharmacologist (M/F) to join our team
Your tasks
- Lead clinical pharmacology program from Pre-IND/Phase 1 to late phase studies, through regulatory submissions, including post marketing for assigned projects
- Act as a core project team member within the development project team and ensure deliverables according to agreed timelines and regulatory requirements
- Responsible for study design and data interpretation of clinical pharmacology studies (including PK, PBPK, first in human, FE, hADME, DDI, special populations); design PK elements of Phase 2/3 clinical studies, and manage the modeling (PK, PK/PD) strategy
- Responsible for co-authoring and preparing clinical documentation
- Represent clinical pharmacology in regulatory interactions with Health Authorities
- Work closely on a day-to-day basis with key stakeholders in development, research and toxicology to strategize and execute clinical pharmacology studies efficiently and with high quality
- Select and work closely with external vendors and consultants supporting non-clinical (DMPK), clinical studies, and modeling activities
- Actively preparing, reviewing and publishing scientific papers and abstracts
- PhD or equivalent experience in clinical pharmacology, pharmacokinetics, and/or pharmacometrics
- >8-10 years industrial experiences in clinical pharmacology, preferably in oncology
- Experience in conducting and interpreting clinical pharmacology studies and translation from preclinical to clinical studies
- Experience leading clinical pharmacology development programs from Phase 1 through to Phase 3 studies
- Experience with translational PK, PBPK, and PK/PD
- Highly motivated team player, proactive with ability to oversee multiple tasks and attention to detail
- Excellent communication skills at different levels, internally, externally, cross-functionally and in highly collaborative matrix environment
- Fluent in English, German would be beneficial
If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application via our careers portal.
External website https://jobs.basilea.com/Senior-Clinical-Pharmacologist-MF-eng-j440.html
Contact email address: daniel.scotcher@manchester.ac.uk - 16th Oct 201 [2968]
PhD Studentship at University of Manchester (MRC DTP): Model-driven optimization of drug therapy and individualisation of healthcare in chronic kidney disease
Funding: MRC DTP studentship funding for tuition fees and stipend for 3.5 years
Supervisors: Dr Aleksandra Galetin (PI), Dr Daniel Scotcher
Background: Chronic kidney disease (CKD) is associated with increasing age, as approximately 50% of individuals over 75 years are affected by some degree of kidney disease. The ageing population is also more likely to have common comorbidities (cardiovascular diseases, diabetes) and be prescribed multiple medications, and hence the risk of potential drug-drug interactions (DDI) in patients with renal impairment is high. However, high percentage of drug product labels lack any evidence-based recommendations for dosage adjustment in patients with advanced renal impairment. Therefore, CKD patients are susceptible to adverse side effects of drugs (e.g., drug induced kidney injury) and increased risk of inappropriate dosing. Model-based precision dosing is an approach for determining suitable dose adjustments using in silico tools (e.g., physiologically-based pharmacokinetic (PBPK) models) to improve drug efficacy and safety in specific populations such as CKD.
Project Aims: This project aims to develop quantitative translational tools to facilitate individualized healthcare in CKD and provide guidance to clinicians for rational dose adjustment when direct evidence in this patient population is lacking. CKD patients exhibit impaired active tubular secretion and therefore reduced renal excretion mediated via renal transporters. PBPK modelling in this project will implement different disease-related perturbations of active secretion and focus on selected renal transporter probes with reported nephrotoxicity/clinical data in patients with advanced CKD. The modelling and simulation will be supported by in vitro studies where activity of selected renal transporters (e.g., OAT1) will be investigated under different experimental conditions mimicking CKD. Uptake of selected drugs (same as used for modelling purposes) in proximal tubule cells will be investigated with cells exposed to plasma from healthy and subjects with severe CKD (to be obtained from collaborator Prof. Philip Kalra, Salford Royal Hospital, Manchester). Functional transporter studies will be supported by LC-MS proteomic measurements of the transporter expression in different experimental conditions and related to protein expression in vivo.
Training The successful applicant will receive state-of-the-art training to build a broad and transferable skillset including in vitro cellular assays, proteomics analysis and PBPK modelling. Active participation in the Centre for Applied Pharmacokinetic Research (CAPKR), University of Manchester will provide opportunity to interact with a multi-disciplinary research team. Student will be encouraged to attend international conferences to promote work and build network as an independent researcher, as well as publish in highly-cited peer reviewed journals. The proposed inter-disciplinary and model-driven approach has strong foundations and builds upon previous and ongoing research in CAPKR.
Eligibility: UK/EU nationals only
Applications: Enquiries about the project should be sent to Dr Aleksandra Galetin: aleksandra.galetin@manchester.ac.uk
Applications should be made via the University of Manchester website: https://www.bmh.manchester.ac.uk/study/research/mrc-dtp/apply/
External website https://www.bmh.manchester.ac.uk/study/research/mrc-dtp/apply/
13th Sep 201 [2967]
Scientific Director Discovery NCE DMPK (all genders)
Your role:
We are seeking an experienced Scientific Director to join our Discovery DMPK team Darmstadt Germany.
As Scientific Director you will champion and develop new scientific ideas and concepts specifically focused on DMPK-related activities. This will include scientific excellence and validation of in vitro, in vivo and in silico DMPK assays. You will provide support for external opportunity evaluations. The role coaches peers and contribute to maintaining a strategic network within and outside. You will provide scientific input to DMPK strategic goals and contribute to the overall goal of Discovery DMPK of selecting high quality molecules to advance in our pipeline. The Scientific Director will collaborate with the Development DMPK teams to ensure that the right development studies are conducted to manage risk and de-risk identified liabilities. The role will have good understanding of PK/PD models preferentially with hands-on experience in using them to support discovery projects.
You will be DMPK representative in project teams and support projects from concept generation up to selection of development candidates (and beyond when needed). As project representative, you will identify DMPK related key issues in Discovery projects and provide inputs to the design of new molecules to address these issues. The Scientific director will compile DMPK data to predict human PK, and in collaboration with other relevant disciplines (Clinical Pharmacology, Discovery Pharmacology, Safety, Formulation, etc) predict human efficacious dose.
Who you are:
- PhD in Drug Metabolism, Pharmacokinetics, Chemistry or related fields with >10 years of experience in DMPK, Clinical Pharmacology or related fields
- Have a proven record of in-depth knowledge of DMPK science and its application in drug discovery
- Good scientific visibility through a substantial track record of relevant publications
- Team player with strong communication skills in a multicultural environment
- Strong negotiation skills with an ability to influence in complex situations
- Highly flexible and creative with a strong sense of responsibility Excellent knowledge of spoken and written English.
External website https://www.merckgroup.com/en/careers/jobs/193786.html
26th Aug 201 [2963]
Summary The Director of the Preclinical Pharmacokinetics and Pharmacodynamics group will be responsible for leading a group of scientists responsible for the design, pharmacokinetic analysis, and reporting of non-clinical animal pharmacokinetic, toxicokinetic, and ADME studies. The Director will be responsible for the oversight of external pharmacokinetic studies, establish deliverables, maintain timelines, and foster open communication with and between the Project Teams, Preclinical Operations, members of the Preclinical PK/PD group, Pharmacometrics, Toxicology and Functional Heads. Responsibilities will also include reviewing and providing content and subject matter expertise relating to preclinical pharmacokinetics, toxicokinetics and ADME sections of regulatory documents to include: INDs, BLAs and other regulatory submissions and responses, as needed.
Responsibilities
- In concert with the Senior Director of Preclinical PK/PD, manage a team of PK scientists tasked with multiple programs with competing and aggressive time lines, prioritizing activities, and working independently
- Effectively manage the preclinical PK team tasked with study design, protocol development and study execution of GLP and non-GLP pharmacokinetic, toxicokinetic, and ADME (as needed) studies
- Provide input to the toxicokinetic design in animal toxicology studies
- Supervise, assist, and mentor contributing scientists on pharmacokinetic analysis, data interpretation, and report writing.
- Empower subordinates and provide for the professional development of their staff
- Functions as study director or principal investigator responsible for externally conducted PK, TK and ADME (as needed) studies as appropriate
- Interact with the Scientific Writing Team in the creation of preclinical PK/TK written and tabulated summaries for IND and BLA applications, as well as IBs, annual updates and other regulatory activities
- Interact closely with other managers and contributing scientists tasked with bioanalytical assay development, and/or sample analysis to ensure seamless and timely transfer of bioanalytical and ADA data to the Preclinical PK/PD team
- Education: PhD, in pharmacokinetics or a biological or related discipline (e.g. pharmacology, toxicology, biology. biochemistry, pharmaceutical science).
- 12+ Years of experience
- Good understanding of both theoretical pharmacokinetics theory and practical application of those principles
- Experience in contributing to pharmacokinetic summaries for regulatory documents successfully submitted to regulatory agencies.
- Advanced scientific writing skills
- Experience in animal PK/TK studies, including protocol design & study conduct
- Experience with PK software and have an understanding of non-compartment & multi-compartment modeling
- Maintains a compliant work environment by staying current with SOPs and being up-to-date with existing GLP guidelines
External website https://careers.regeneron.com/job/REGEA0026306922/Director-Preclinical-Pharmacokinetics-and-Pharmaco
Contact email address: christopher.kohl@idorsia.com - 22nd Aug 201 [2961]
About Idorsia Pharmaceuticals Ltd
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets. ob Responsibilities
Providing quantitative pharmacokinetic and pharmacodynamic modeling and simulation expertise to pre-clinical project and Life cycle teams Applying quantitative PK/PD modeling and simulation to inform pre-clinical candidate selection Being a champion and advocate for pharmacometrics within the company Analyzing, interpreting and reporting pharmacokinetic and pharmacodynamic data from pre-clinical studies Performing PK/PD simulations and predicting pre-clinical and clinical PK from nonclinical data as appropriate Collaborating, mentoring and guiding other DMPK team members with pharmacometric support on their projects Interacting cross-functionally with other departments including Medical Organization, Toxicology, Formulation and Discovery Preparing and/or reviewing PK, PK/PD components of internal documents, briefing books and regulatory submission documents (e.g. IND, NDA, IB) Actively preparing, reviewing and publishing scientific papers and abstracts Representing the DMPK line on project teams spanning Discovery to NDA
Candidate’s Requirements
- PhD in a relevant discipline (e.g. Quantitative Pharmacology, Pharmaceutical Sciences, Chemical Engineering)
- 2 to 3 years experience in Modelling and Simulation in the Pharmaceutical Industry or Contract Research Organisations as a minimum
- Proficient in spoken and written English
- Strong understanding of pharmacokinetic and pharmacodynamic principles including PBPK
- Good general knowledge about DMPK principles, DMPK in vitro assays, DMPK in vivo models
- Hands-on experience with modeling and simulation software packages (WinNonlin Phoenix, Monolix, R)
- Experience with Gastroplus, SimCYP would be advantageous
- Must be a team player and great communicator
- Self-driven and enthusiastic scientist
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution-oriented environment where you can make a difference
- An innovative and open culture in a truly multicultural environment
- A competitive salary and generous social benefits
Country: Switzerland
Business Area: Drug Discovery - Pharmacology DMPK
Schedule: Fulltime
Job Type: Permanent
Job ID: 1256 Please apply exclusively via the career portal on our home page.
External website https://careers.idorsia.com
Contact email address: telder@stem-sourcing.com - 2nd Aug 201 [2960]
URGENT CLIN PHARM M/S QSP NEED: Director level roles. Individual contributor or roles that require the management, training and mentoring of junior scientists. Progress your career in a growing environment that is on the cutting edge. Openings in small molecule, gene therapy and antibodies
Director, Clinical Pharmacology
Job Description
Company is looking for a Clinical Pharmacology leader to join the team in Boston, MA. The Clinical Pharmacology leader is a highly scientific role, supporting multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. He/She will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed. The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, and DDI, as well as a good understanding of related disciplines such as pharmaceutical development, regulatory, and overall drug development.
Key Responsibilities:
- Performs analysis of clinical pharmacology data (PK/PD) from phase 1-4 clinical studies with minimal supervision.
- Develops clinical pharmacology data analysis plans with minimal supervision.
- Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions.
- Provides complex clinical pharmacology input to clinical development plans, Investigator’s Brochure and Clinical Pharmacology section of INDs, CTAs and/or NDAs with supervision.
- Leads study conceptualization, protocol development, and study start-up activities, including site initiation and investigator meetings.
- Prepares responses to inquiries from regulatory agencies with minimal supervision
- Provides scientific and technical input about clinical pharmacology-related issues within project teams, as assigned.
- Provides program development support with a higher level of oversight.
- Collaborates with colleagues in bioanalytics, biometrics, clinical development, drug metabolism and pharmacokinetics, toxicology, and regulatory affairs for clinical studies.
- Demonstrates a good understanding of the requirements of the study design, conduct, analysis and report writing for regulatory submissions.
- May have direct reports
- Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or other life sciences with 8+ year’s experience in the Biotechnology/ Pharmaceutical Industry or post-doctoral training.
External website https://www.stem-sourcing.com
2nd Aug 201 [2959]
Pharmacometrician - Brisbane, Australia
The Position
Model Answers R&D Pty Ltd is seeking applications for a pharmacometrician to join their team in Brisbane, Australia. The successful applicant will work in an inspiring group that provides a range of quantitative solutions to a global client network. The position would suite a highly motivated individual with a desire to continuously learn, and looking for a challenging opportunity to facilitate successful drug development. Applicants should have excellent time management and communication skills with a background in pharmacokinetic / pharmacodynamic data analysis. Applicants should also have programming experience in SAS, R or SPlus, and demonstrated modelling experience using NONMEM or equivalent software.
Essential Skills:
- Qualification in Pharmacokinetics or Pharmaceutical Sciences
- Experience using statistical modelling approaches to analyze PK/PD, PK, and population PK data
- Use of modelling and reporting software such as NONMEM, MATLAB, SAS, R, among others
- Technically orientated and very computer literate
- Excellent attention and accuracy with details
- Working closely with the team to ensure a seamless operation across all aspects of the business
- Ensuring Model Answers processes are followed and developed, including, but not limited to, any matters relating to QA, QC, HR, Science, Audit
- Project tracking and task management, working with the Model Answers Team
- Ongoing learning and development
- Contributing toward the cultural goals of Model Answers and sharing with team members
All positions are located in the central business district of Brisbane. Model Answers R and D Pty Ltd is a growing consultancy business dedicated to helping pharmaceutical and biotech companies make successful drug development decisions. Employees, shareholders and equity stake holders are expected to be upstanding members of the community, who have an inbuilt desire to develop, create, and innovate. Opinions and ideas are welcomed, resulting in a dynamic business, led by those who work in the business.
Interested applicants should apply via recruitment@model-a.com.au or refer to our website (www.model-a.com.au) for further information. Applications close 26 August 2019.
External website https://www.model-a.com.au