PK/PD and Other Jobs

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26th May 2017 [2835]

Genentech is hiring.

The Position:

Associate Scientist/Scientist/Sr Scientist, Preclinical and Translational PKPD (PTPK) (Job ID 3403146330)

The Preclinical and Translational PKPD (PTPK) Department within Development Sciences at Genentech, Inc. is seeking a PhD level scientist who is driven to understand the pharmacokinetics (PK) and pharmacodynamics (PD) of novel drug candidates. The candidate will be responsible for investigating the pharmacokinetics, biodistribution, and PKPD relationships of novel therapeutics in preclinical models to identify lead candidates for further development, and for translating preclinical PKPD information to patients. The candidate will be working in close partnerships across various functions including Research, Development Sciences, Clinical Sciences, Biostatistics, and Regulatory. The candidate will represent the department on cross- functional project teams as a PKPD representative and present PKPD results at cross- functional teams, department meetings, review committees, and conferences.

Who You Are:

We are looking for individuals who are inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture.

External website http://bit.ly/2qkwTxw


Contact email address: chee.ng@uky.edu - 11th May 2017 [2833]

The School of Pharmacy at the University of Kentucky is offering a postdoctoral fellowship position in clinical pharmacology and pharmacometrics.

This position is focused on the application of pharmacokinetic/pharmacodynamic and disease modeling/simulation to facilitate the drug development in industry and improve patient care in academic setting.

The candidate will have the opportunity to gain a breadth of experience including: population pharmacokinetic/pharmacodynamic and complex mechanistic modeling of the biotechnology and small molecule drugs; disease progression and risk prediction modeling for patients with various diseases using data from clinical settings and private/government health insurance database; and others.

The candidate also has an option to involve in the development and evaluation of the advanced numerical and computation methods for population data analysis.

An ideal candidate will have a doctoral degree (PhD, PharmD) in pharmaceutical science, engineering, biology, pharmacy or other related field and have experience or familiarity with mathematical modeling, such as NONMEM, MATLAB, R, or any other applicable software. Knowledge with C++ and phyton programming is a plus.

For more details and information and how to apply please follow the link:
https://ukjobs.uky.edu/postings/143145
Additional inquiries may be sent to chee.ng_at_uky.edu

Thanks. Chee
Chee Meng Ng, PharmD, PhD, FCP Associate Professor of Pharmaceutical Science College of Pharmacy University of Kentucky Email: chee.ng_at_uky.edu

External website http://https://ukjobs.uky.edu/postings/143145


Contact email address: hequn.yin@novartis.com - 3rd May 2017 [2832]

Associate Director Position Profile – Clinical Pharmacology Oncology

Support oncology drug development by providing clinical pharmacology / DMPK expertise across early and full development phases, and global medical affairs. Represent Oncology Clinical Pharmacology (OCP) global line function on cross-functional teams and influence design, execution, and analysis of clinical pharmacology / DMPK related study components.

1) Contributes expert pharmacokinetic / DMPK input into key pre-clinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, investigator brochures, IND / IMPD’s and NDA’s within agreed timelines, and meeting all regulatory requirements under minimal guidance from manager. 2) Designs clinical pharmacology strategy for assigned program and coordinates pharmacokinetic / DMPK related elements for preclinical and/or clinical projects. Identifies potential project hurdles, suggests solutions and establishes contingency plans. Represents OCP on Global Program Team(s) or early project teams. 3) Performs or oversees PK and PK / PD analyses using a variety of tools and approaches. Integrates, interprets and reports data to project teams and other customers. 4) Ensures constructive collaboration within drug development teams (GPTs, etc) and with other internal partners (e.g. DMPK, Toxicology, Modeling and Simulation, Formulations, Drug Regulatory Affairs, Clinical Development). 5) Defines and updates as appropriate the PK, PK/PD, DMPK biopharmaceutical and M and S requirements in the OCP and/or preclinical project development plans. 6) Monitors study timelines, objectives and budgets, ensures accuracy of project progress in company tracking tools (e.g. Succeed). Assures rapid and effective communication of data to project teams. 7) Leads or participates in OCP or project sub-teams. Coordinates with appropriate sub-team members and/or prepares summary documentation. 8) Maintains and enhances technical and drug development expertise (e.g. training courses, external meeting attendance). May act as technical subject matter expert in key clinical pharmacology / DMPK related area. 9) Attends meetings with external parties including investigators, outside experts, and health authorities. 10) May manage one or more junior OCP associates. Coaches and mentors other OCP associates.

Ph.D. in pharmacokinetics, drug metabolism or a related discipline, or a Pharm. D. with appropriate post-doctoral training

Fluent English (oral and written) Send CV to: hequn.yin@novartis.com
Contact email address: lyn@medimmune.com - 18th Apr 2017 [2830]

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Senior Clinical Pharmacokineticist or Principal Clinical Pharmacokineticist in Mountain View, CA, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

And we’re excited to share that our work at the Mountain View site (along with some other AstraZeneca Group Companies in the Bay Area) will relocate to South San Francisco by end of 2017. Click here for more information on this new facility.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Main Duties and Responsibilities

You will function as the global Clinical Pharmacology/DMPK (CPD) team representative for biotherapeutic projects at various stages of research and development (target validation through life-cycle management) and be responsible for all aspects of pharmacokinetic/pharmacodynamics (PKPD) -related support for biotherapeutic products, including design of studies, analysis and reporting of data, and communication of data in regulatory documents and meetings. You will also be responsible for providing clinical pharmacology expertise into clinical development plans, including the design, conduct and interpretation of relevant clinical pharmacology studies, including PKPD studies, analysis of data using complex PKPD modelling and simulation methodologies, development and delivery of regulatory strategy (e.g IB/IND, end of phase 2, and BLA) etc, and data analysis and reporting of clinical studies.

Additionally, you will function as the sole point of contact for all CPD activities on projects at all stages of discovery and development and be able to influence team strategy using modelling expertise; Be pivotally involved in assessing and managing analyses of PK/PD data, integrating clinical trial simulation strategies and disseminating the clinically relevant risk/benefit implications to the Company\\\\\\\'s clinical development teams; Collaborate with biostatisticians, clinicians and clinical operation managers for the appropriate design of Phase I-IV studies; contribute to the investigators brochure, clinical study protocol and report analysis and reporting of data, and communication of data in regulatory documents and meetings; Drive clin pharm regulatory strategy for projects at all stages -- IND to BLA -- and defend strategy at regulatory meetings; Help design and conduct translational PK/PD modelling and simulation to support drug design goals, designs of PK/PD and safety assessment studies, and dosing justifications for first-in-human clinical studies; Collaborate with toxicologists on the design, monitoring, and reporting of nonclinical safety studies; prepare TK subreports; comply with good laboratory practice (GLP) regulations for GLP studies. Perform PK analyses for GLP studies per SOPs, record data and analysis results in GLP-compliant manner, ensure timely and clear communication with GLP SD/PI on GLP studies, contribute to GLP study reports; Mentor other junior PK scientists staff on clin pharm science and strategy.

Essential Requirements

For Sr Clinical Pharmacokineticist: For Principal Clinical Pharmacokineticist: Desirable Requirements Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised

External website https://astrazeneca.wd3.myworkdayjobs.com/MedImmune-Careers/job/US---Mountain-View---CA/Senior---Principal-Clinical-Pharmacokineticist_R-006125


13th Apr 2017 [2829]

The UNC Schools of Medicine, Public Health, Dentistry, Nursing and Pharmacy comprise one of the nation’s few comprehensive academic health centers located on a world-class research campus.

The Division of Pharmacotherapy and Experimental Therapeutics in the UNC Eshelman School of Pharmacy invites applications for a full-time, fixed term faculty position at the rank of Research Assistant Professor. This Division is a designated Pharsight Phoenix® Center of Excellence, and is a nationally recognized, dynamic and collegial faculty whose vision is to lead the nation in achieving excellence in innovative translational research, education, and progressive pharmacy practice to optimize drug therapy outcomes. The Division has vibrant fellowship and graduate programs, including an NIH-funded T32 postdoctoral training program in Clinical Pharmacology in collaboration with Duke University and the Hamner Institute for Drug Safety Sciences. DPET faculty are in the process of applying to UNC for designation of a new center: The Pharmacometric Center for Precision Medicine. The candidate will be a member of this Center.

The position offers a unique opportunity to work as part of a multidisciplinary team on infectious disease projects focused on the application of mathematical modeling and simulation to characterize drug pharmacokinetics, pharmacodynamics and toxicodynamics.

The successful candidate will work in the laboratory shared by Alan Forrest, PharmD and Gauri Rao, PharmD, MS (computer engineering), MS (pharmacometrics), and will focus on challenging preclinical (in vitro and animal), translational and clinical modeling projects in the areas of antiinfectives (mainly anti-bacterials). The projects will involve the use of nonlinear mixed effects and physiologically-based modeling techniques, and other biostatistical applications in preclinical, translational and clinical drug development research, to identify optimal dosing regimens and laboratory and clinical trial design.

Qualified candidates must have a doctoral degree in Pharmacometrics, Pharmaceutical Sciences, Biostatistics, Biomedical Engineering, Medicine, Pharmacy or a closely related discipline.

The successful candidate must demonstrate expertise in modeling, simulation, and quantitative systems pharmacology. Extensive software (e.g., NONMEM, ADAPT, R) and programming proficiency is preferred.

Excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential. Participation in teaching and grantsmanship is also expected.

The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.

Qualified applicants should apply at http://unc.peopladmin.com/postings/118159 and attach the following materials:

1) a letter of interest addressed to: Dr. Alan Forrest (Search Committee Chair) UNC Eshelman School of Pharmacy 2317 Kerr Hall 301 Pharmacy Lane Chapel Hill NC 27599

2) A complete curriculum vitae

3) The names and contact information for 3 professional references

4) A detailed research project abstract.

External website http://unc.peopleadmin.com/postings/118159


Contact email address: dirk.garmann@bayer.com - 13th Apr 2017 [2828]

Dear all,

Clinical Pharmacometrics at Bayer is now hiring a Senior Modeling and Simulation Expert, to be located in Berlin or Wuppertal (close to Cologne/Düsseldorf), Germany.

If you are a highly motivated, well trained, experienced Pharmacometrician with hands-on modeling capabilities, the following position might be of interest for you:

The Senior M&S Expert at Bayer leads M&S project teams and provides scientific supervision to M&S experts and evaluators. He/she develops and implements state-of-the art population PK/PD M&S methodologies to improve project support in all therapeutic areas and in all development stages. He/she drives, either independently or together with the pharmacometric lead, model-based drug development strategies in order to establish a model continuum by optimizing prospective studies, maximizing the use of available data and ensuring translation of pre-clinical into clinical information. He/she is responsible for the assessment of pharmacological plausibility of population PK/PD M&S results, provides regulatory knowledge in all stages of drug development and ensures compliance with regulations and guidance of regulatory authorities.

We offer a competitive salary in an international environment as well as excellent opportunities for professional and personal development.

If you are interested please use the link to the web posting and online application:

https://karriere.bayer.de/de/job/Senior-Modeling-Simulation-Expert-m-f--0000192307.html

Freundliche Grüße / Best regards,

Dr. Dirk Garmann Head of Quantitative Pharmacology Bayer AG Drug Discovery, Pharmaceuticals Quantitative Pharmacology

External website http://https://karriere.bayer.de/de/job/Senior-Modeling-Simulation-Expert-m-f--0000192307.html


31st Mar 2017 [2827]

(Senior) Scientist (m/f) PK/PD Modeling & Pharmacometrics MorphoSys AG, Munich, Germany Reference number 154-2016 https://www.morphosys.com/careers/job-opportunities

As one of the leading public biotech companies in Europe, we are committed to developing the medicines of the future. Building on our portfolio of innovative antibody technologies, we are actively pursuing new therapeutic approaches in close collaboration with the world‘s foremost pharmaceutical companies and, increasingly, under our own initiative. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Martinsried near Munich!

Your Responsibilities

Your Requirements Thank you for your interest! We are looking forward to receiving your pertinent application documents. For your application please use exclusively our career portal www.morphosys.com/careers. We do not only offer excellent career prospects, but support you from the very start – also helping you move. MorphoSys is an equal opportunity employer.

External website http://www.morphosys.com


28th Mar 2017 [2826]

A Postdoctoral Fellow position is available in the Department of Pharmaceutical Sciences at the University of Oklahoma (OU) College of Pharmacy. The postdoctoral fellow will be involved in collaborative projects using animal models and mechanistic, quantitative systems pharmacology approaches to describe and predict pharmacokinetics and pharmacodynamic responses of various therapeutic agents, with the aim of facilitating translational research and drug development in oncology.

The ideal candidate has a PhD in pharmaceutical/medical sciences, cancer pharmacology, engineering or related fields with a strong publication record. The candidate should have a background in basic pharmacokinetics and hands-on experience with cancer animal models, computational modeling and simulation of pharmacokinetic and/or pharmacodynamic systems and its application to various biological systems using modeling software such as Phoenix, MATLAB, and/or R. Good communication/organization skills with the ability to work in collaborative environment are essential.

The position is jointly mentored by Professors Sukyung Woo and Youngjae You. To apply, please send curriculum vitae, cover letter stating your interest and summary of past research experience, and the names and contact information of three references via email to Dr. Sukyung Woo at sukyung-woo@ouhsc.edu and Dr. Youngjae You at youngjae-you@ouhsc.edu.

OU College of Pharmacy (http://pharmacy.ouhsc.edu/ ) is located in the campus of the University of Oklahoma Health Sciences Center (OUHSC) in Oklahoma City with access to the extensive resources of Peggy & Charles Stephenson Cancer Center and Oklahoma Medical Research Foundation. The University of Oklahoma Health Sciences Center is an EEO/AA Employer.


Contact email address: john_rynak@h3biomedicine.com - 28th Mar 2017 [2825]

Clinical Pharmacologist
Location: Cambridge, MA
Job Code: CP-CL-0001-17
Clinical Pharmacologist
Job Code: CP-CL-0001-17 Reporting to the Chief Medical Officer, the Clinical Pharmacologist will be responsible for leading scientific and strategic planning, internal and external project communications, and clinical documentation for NDA-directed clinical development programs for H3 Biomedicines drug candidates with an emphasis on clinical pharmacology studies.
Principal Duties and Responsibilities

Qualifications
About H3 Biomedicine Inc.
H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.

External website http://www.h3biomedicine.com


Contact email address: melanie.buckler@cslbehring.com - 3rd Mar 2017 [2824]

The position of Director, Quantitative Pharmacology is a technically-driven, high-impact role in Clinical Pharmacology and Early Development (CPED; CMO function), which provides the incumbent an unique opportunity to advance and lead the field of pharmacometrics across the global R and D organization. The appointee will lead pharmacometrics science within R&D, at a portfolio level, spanning the pre-clinical stages through all clinical stages at CSL, working closely with CPED's Directors of Clinical Pharmacology in identifying pharmacometric opportunities and strategy across portfolio to maximize value. The industry-experienced person undertaking this role will have a strong and proven pharmacokinetic/pharmacometrics knowledge, with demonstrable advanced modelling and simulation skills and pharmacostatistical knowledge. Close collaboration with various non-clinical, Research, Clinical R&D, and Commercial Development/Medical Affairs functions will be crucial, as well as strong interaction with world-leading pharmacometric (quantitative pharmacology) experts. The appointee will be required to ensure provision of pharmacometrics support to all R&D projects through the use of internal resources and external alliances, though undertaking hands-on modelling and simulation work on selected crucial projects will also be a requirement.

Education
Doctoral degree with demonstrated expertise in pharmacometrics and strong quantitative skills (e.g. proven experience in most of the following areas: population and PK/PD modelling, mechanistic modelling, systems biology, species scaling methodologies and derivation of first-in-human doses, disease modelling and meta-analyses).

Experience
A minimum of 8 years of pharmaceutical industry (or relevant) experience, specifically contributing to pharmacometrics aspects of clinical drug development. In-depth knowledge and experience in advanced PK and PK/PD Advanced pharmacometric knowledge in one of the following core sub-specialty: Systems Pharmacology, advanced Exposure-Response Models, Disease Models, Physiological-Based Pharmacokinetic Models Working knowledge and experience of software such as NONMEM, SAS, S-Plus, R, WinNonlin, and other server-based data processing and modelling tools Knowledge of the role of pharmacometrics in drug development and FDA/ICH requirements for drug registration Knowledge and application of statistics, random effects modelling, mixed effects modelling, data mining, population PK/PD analyses and modelling (including nonlinear models), Bayesian methods, clinical utility indices, and Monte-Carlo simulation Clinical trial design and simulation PK and PD drug interactions, in vivo/in vitro models Ability to understand, lead and implement all aspects of pharmacometrics needs across a variety of disease areas Regulatory and Quality Systems Representation and pharmacometrics leadership at regulatory authority meetings IND, CTA submissions ICH Good Clinical Practice and Good Laboratory Practice EMA and FDA guidelines Quality Control systems and processes for data analytical work to meet Regulatory requirements In-depth knowledge of, and experience with global clinical pharmacology and pharmacometrics regulatory requirements

External website http://https://csl.wd1.myworkdayjobs.com/en-US/CSL_External/job/Americas-US-PA-King-of-Prussia-CSL-Behring/


13th Feb 2017 [2823]

The Certara Phoenix Application Engineer will work directly with external and internal customers/clients to provide training, demonstrations, and overall product support. The Application Engineer encourages and strengthens business relationships with customers by providing technical guidance and expertise, supporting sales team efforts, and collaborating with software development teams on product enhancements.

Essential Duties and Responsibilities:

Education and Experience Requirements:

  • Knowledge of modeling software (NONMEM, Monolix, MATLAB, R, Phoenix)
  • Experience and familiarity with Certara products and line of business a plus
  • Knowledge/Skills/Abilities:

    Please submit your application here - https://workforcenow.adp.com/jobs/apply/posting.html?client=certara&jobId=184559&lang=en_US&source=CC3

    External website http://www.certara.com


    13th Feb 2017 [2821]

    Postdoctoral Researcher: Quantitative Systems Pharmacology Institute of Quantitative Systems Pharmacology (IQSP) - Carlsbad, CA 92008
    A postdoctoral position is available in the Institute of Quantitative Systems Pharmacology (IQSP), a nonprofit organization. IQSP works with its academic and commercial partners to promote translational research and instruction in QSP, an emerging field that brings together knowledge in multiple scientific disciplines including biology, physics, chemistry, pharmacology, pharmaceutical sciences, engineering, computational modeling, clinical sciences, and regulatory sciences. QSP aims to increase the cost-efficiency and time-efficiency of drug development, is considered of high importance by NIH and FDA, and represents highly valued skill-sets.

    The ideal candidate would have fewer than three years postdoctoral experience, a strong publication record in the field of molecular cancer biology, and expertise of establishing and handling gene manipulated cancer cell and mouse models. Good communication and organizational skills with enthusiasm for translational research are essential. Familiarity of The Cancer Genome Atlas database, experience with pharmacokinetics/pharmacodynamics, and proficiency in quantitative software such as R, SAS and MATLAB is preferred. The successful candidate will work on NIH-funded projects on multiscale models that link receptor signaling events to treatment outcomes.

    IQSP is located in Carlsbad/San Diego, CA.

    To apply for this position, please send a cover letter, CV and 2 letters of reference to:

    Jessie L.-S. Au, Pharm.D., Ph.D., Founding Director, IQSP

    Job Type: Full-time

    Required education:

    Doctorate

    External website http://www.postdocjobs.com/jobs/jobdetail.php?jobid=4019675


    Contact email address: george.peterson@regeneron.com - 4th Feb 2017 [2819]

    Regeneron Pharmaceuticals Title: Senior Statistician, Pharmacometrics Location: Tarrytown, NY Req#:7576BR

    Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

    Description:
    These responsibilities of this position will be to: 1) Interact with BDM to generate STDM specifications and validate both SDTM and ADaM data sets 2) Validate the SAS code per study SAP instructions, 3) Validate the PK and PK/PD output files (TFLs). 4) Work with other members in the Pharmacometric function to generate exploratory (ad hoc) Tables and Figures.

    This individual will provide SAS programing support, data set creation, validation and management within the clinical pharmacometric function. Working across functional areas with BDM and Clinical Pharmacology, the incumbent will support the creation of SAS code specification from the approved study SAP, and validation of SDTM data set.

    From SDTM data set this position will:

    Working in close association with Clinical Pharmacology generate exploratory post hoc Tables and Figures from raw data in LIMS and clinical study database Additional responsibilities include: Requirements:
    1. Bachelors degree +7 years experience or Masters degree +4 years experience
    2. Prior experience in successful regulatory NDA/BLA submissions.
    3. Background in creating SDTM and ADaM data sets in SAS.
    4. Well experienced in SDTM and ADaM data set validation.
    5. Well experienced Generate and validate TLF.
    6. Experienced in in generation and validation of NONMEM data sets for Pop PK and PK/PD.
    7. Experienced in generation of high quality graph in SAS and/or R
    8. Experienced in creation of exploratory PK and PK/PD data set from LIMS and clinical raw data sets.
    9. Prior experience in support of Clinical Pharmacology, modeling & simulation, and other pharmacometric activities.
    TECHNICAL SKILLS: CORE COMPETENCIES: This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry.

    Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.

    Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

    External website http://careers.regeneron.com


    Contact email address: karin.opdecamp@hays.com - 30th Jan 2017 [2818]

    Post Doctoral Scientist – 1 year - Belgium

    In vitro Biopharmaceutics/ Physiology based Pharmacokinetic (PBPK)/ automation

    This position is to join the R&D center of a well-known pharmaceutical company located in Belgium. The candidate will work under a consultancy contract on an employee status.

    As a post-doctoral scientist your mission is to design, validate and implement automated high output workflow in the R&D biopharmaceutical platform. Focus will be set on scientific innovation to strengthen the knowledge about the gastro intestinal absorption potential of new compounds such as to ensure optimal in vivo performance.

    You will design, coordinate, execute and report experimental work related to biopharmaceutics and PBPK modelling in support of drug development. This will include the continuous improvement of existing workflow and the participation to the evaluation of new analytical techniques in the area of bio relevant testing. You will build and maintain strong relations with key stakeholders including discovery science, clinical pharmacology, drug product development and analytical development. You will work in a multidisciplinary team of researchers internally as well as externally.

    For this position we are looking for a PhD in Biopharmaceutics, Biology engineering or related sciences with relevant and Hands on experience in biopharmacy related techniques such as solubility, dissolution, solid state characterization, precipitation, etc. Experience with down scale and automated high-throughput experimentation and characterisation platforms is required. We look for a candidate with strong interest in API physico-chemistry, solid state, drug absorption principles, formulation optimisation, pharmaceutics and mechanistic design and with an understanding of the concepts behind PBPK modelling (Gastroplus/ Simcyp). Highly motivated, excellent organisational, communication and collaborative skills. Fluent English.


    Interested please send your CV to Karin.opdecamp@hays.com or call Karin at +32 (0)10 233 707 for more information.


    Contact email address: annie.lumen@fda.hhs.gov - 25th Jan 2017 [2817]

    A fellowship opportunity is currently available in the Division of Biochemical Toxicology (DBT) at the National Center for Toxicological Research (NCTR) of the U.S. Food and Drug Administration (FDA).

    NCTR conducts FDA mission-critical research specializing in the development of scientific strategies to support regulatory decision-making. DBT focuses on fundamental and applied research designed to elucidate mechanisms of toxicity and support risk-assessment for chemicals of interest to the FDA. The selected participant will work with Dr. Annie Lumen on the development and use of pharmacokinetic and mechanistic models on projects in support of NCTR's objectives and the FDA mission.

    Opportunities may include:

    Through this fellowship, the selected participant will have the opportunity to learn and apply computational modeling skills, including PBPK and Biologically Based Dose-Response modeling, to address public health-related issues and gain experience in developing tools geared towards the advancement of regulatory science. S/he will collaborate with FDA investigators at NCTR and with investigators in other FDA centers. During the project, s/he will be actively encouraged to present the research at internal and external meetings and publish the findings in peer-reviewed journals.

    Qualifications:

    To Apply: To be considered, please send a current CV/resume to the attention of annie.lumen@fda.hhs.gov

    External website http://https://www.training.nih.gov/postdoc_jobs/view/_27/4502/Computational_Modeling_Fellowship


    18th Jan 2017 [2816]

    Associate Director/Director, Drug Metabolism-Pharmacokinetics

    Summary:
    The Experimental Pharmacology department is seeking a highly motivated Associate Director/Director of Drug Metabolism-Pharmacokinetics to join our efforts in developing antibody-based therapies that improve outcomes for patients with cancer. The successful candidate will oversee a team that develops innovative bioanalytical assays and critical reagents; designs, implements, and interprets preclinical pharmacokinetics, metabolism, and transporter studies; and writes sections of regulatory submissions and acts as a subject matter expert for interactions with regulators. Integrating DMPK concepts from small and large molecules to inform early research efforts, lead selection, and IND-enabling studies will be key.

    Responsibilities:
    Responsibilities include the design and execution of DMPK strategy for bringing early research candidates to development decisions, and then forward into clinical trials. The successful candidate will have a passion for science and innovation; provide leadership within the department and wider organization; and coach, mentor, and develop DMPK scientists.

    Qualifications:

    Desired: Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

    To apply for this position, please visit http://chp.tbe.taleo.net/chp04/ats/careers/requisition.jsp?org=SEAGEN&cws=1&rid=1812

    External website http://chp.tbe.taleo.net/chp04/ats/careers/requisition.jsp?org=SEAGEN&cws=1&rid=1812


    17th Jan 2017 [2815]

    Tenure Track Assistant/Associate Professor - Pharmacometrics Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota

    The University of Minnesota’s College of Pharmacy, Department of Experimental and Clinical Pharmacology (ECP) invites applications for the position of Assistant or Associate Professor with a focus in Pharmacometrics. We are seeking individuals who will complement our existing strengths in pharmacometrics by contributing field-shaping science to the areas of quantitative systems pharmacology, systems biology, disease modeling, methodological or computational skills related to pharmacometrics. Successful candidates will possess an earned doctorate (e.g., Pharm.D., M.D., Ph.D.), and must have research experience that will enable the establishment of a program of clinical/translational research. The candidate will also interact with members of other disciplines, schools, centers and research groups at the University to advance our capacity to make significant contributions to quantitative systems pharmacology. Ideal candidates will understand the profession of pharmacy; complement other departmental strengths including pharmacogenomics, drug metabolism and pharmacotherapeutic research expertise within select therapeutic areas; and contribute to the instruction of professional pharmacy and graduate students.

    A record of strong academic, industrial, or organizational leadership and collaboration, as well as evidence of excellent teaching and communication skills will strengthen the application. Candidates must be eligible for appointment at the rank of Assistant or Associate Professor at the time of employment. The University of Minnesota offers an exceptional benefit package including the faculty retirement program and excellent medical, dental and disability insurance programs. A competitive salary and start-up package are offered commensurate with the candidate’s experience and skills.

    Our faculty are committed to our common mission which is to advance the science, teaching, and practice of human pharmacology and therapeutics to improve the safe, effective, and economical use of medications in patients. Our faculty are also committed to the education of Pharm.D. and graduate students who together, with our staff, work to discover, apply and disseminate new knowledge to support our mission. Candidates who share our Department’s commitment to outstanding research, innovative teaching and leadership in the optimization of drug therapy, are encouraged to apply. The UMN College of Pharmacy has distinguished itself on the basis of its national and international reputation as the 2nd highest ranked College of Pharmacy according to the U.S. News & World Report, and recently as the 3rd ranked School of Pharmacy in terms of research funding according to the American Association of Colleges of Pharmacy. It is located within one of the largest academic health centers in the U.S., with nationally recognized programs in public health, medicine, nursing, dentistry, and veterinary medicine.

    Major campus research facilities include a Clinical and Translational Science Institute, the University of Minnesota Super Computing Institute, Genomics Center and Comprehensive Cancer Center. The Department houses the Clinical Pharmacology Analytical Services facility, the Center for Forecasting Drug Response and other specialty centers including the Institute of Personalized Medicine. In addition, numerous affiliated health care systems with exceptional research and educational programs partner with the College. The Twin Cities also has a large number of cutting-edge biomedical companies eager to collaborate with the academic community. The close proximity of the College to this research-rich environment provides unequaled opportunity for faculty to excel.

    The initial review of applications will begin on December 01, 2016; however, applications and nominations will be accepted until the position is filled. For specific questions about this position, please contact the search chair, Richard Brundage, Pharm.D., Ph.D. brund001@umn.edu.

    Your complete application should include:

    Your curriculum vitae, Your letter of interest.. The letter of interest should explain your qualifications for the position. A statement of research goals (attached as Additional Document). Arrange for three letters of recommendation (electronic copies are preferred) to be sent separately to: c/o Darren Hoff at DKHoff@umn.edu. Or recommendation letters can be sent to: University of Minnesota College of Pharmacy c/o Darren Hoff 5-130 Weaver Densford Hall 308 Harvard Street SE Minneapolis, MN 55455-0343 All applicants must apply via the University of Minnesota Online Employment System by selecting the link below: https://www.myu.umn.edu/psp/psprd/EMPLOYEE/HRMS/c/HRS_HRAM.HRS_APP_SCHJOB.GBL?Page=HRS_APP_JBPST&Action=U&FOCUS=Applicant&SiteId=1&JobOpeningId=305609&PostingSeq=1

    The University of Minnesota is an equal opportunity educator and employer

    External website http://www.pharmacy.umn.edu/about/job-opportunities


    16th Dec 2016 [2814]

    PHARMACOMETRICS STAFF SCIENTIST

    A full-time pharmacometrics staff scientist will work as part of a multidisciplinary team on projects focused on the application of mathematical modeling and simulation to characterize drug pharmacokinetics/pharmacodynamics (PK/PD). The incumbent will work on projects that will involve the use of nonlinear mixed effects and physiologically-based modeling techniques, and other biostatistical applications in drug development research, to identify optimal dosing and clinical trial design.

    Percentage Effort; Principal Functions; Description

    1. 50%, PK/PD data analyses: Use PK/PD modeling and simulation techniques to perform analyses designed to optimize clinical and experimental design and identify optimal drug dosing. Record and report results to the group. Prepare reports for submission to study sponsors and regulatory agencies.
    2. 25%, Mentoring students and postdoctoral Fellows: Introduce newer group members to the techniques and software used within the group. Help graduate students with designing and performing necessary experiments. Train new group members to formulate research questions, prepare data analysis plans and/or experimental protocols, answer project related questions, and help with record keeping and preparation of reports/manuscripts.
    3. 20%, Managing group activities: Oversee and help with project related questions, ordering supplies and tracking budgets from multiple funding sources. Serve as primary contact for service providers, coordinate service agreements and ensure training/compliance of all group members.
    4. 5%, Classroom teaching: Give lectures or lead a case discussion in graduate or professional level pharmacometircs/clinical pharmacology courses.
    Education and Experience: Minimum of a M.S. or doctoral degree in pharmaceutical sciences, engineering, statistics, or a related field. Extensive software (e.g., NONMEM, R) and programming proficiency is preferred. Excellent oral and written communication skills and ability to work independently as well as a member of an interdisciplinary team are essential.

    Interested applicants should submit a letter describing personal goals as they relate to the position, Curriculum Vitae, and 3 professional references at https://unc.peopleadmin.com/postings/111581.

    The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.

    External website http://https://unc.peopleadmin.com/postings/111581


    Contact email address: recruitment@simcyp.com - 8th Dec 2016 [2813]

    Research Associate / Research Scientist (Oral Absorption/Formulation) – Simcyp (a Certara company)

    Closing Date for Applications: Midnight (UK time), Sunday 8th January 2017

    Line of Management: Senior Scientist in the Modelling and Simulation Group

    Position Type: Full Time

    Holiday Entitlement: 25 days, plus statutory bank holidays

    Salary: £30,000 - £38,000 per annum dependent on qualifications and experience (plus discretionary bonus, pension contribution, health scheme etc.)

    Location: Sheffield, UK

    Job Overview:

    We have an immediate opening for a Research Associate / Research Scientist with a background in the area of oral drug product delivery. Experience is required in the areas of drug product formulation development, oral drug delivery, biopharmaceutics and mechanistic absorption modelling preferably in a PBPK framework.

    Requirements :

    Essential

    External website http://https://workforcenow.adp.com/jobs/apply/posting.html?client=certara&jobId=12781&lang=en_US&source=CC


    Contact email address: recruitment@simcyp.com - 8th Dec 2016 [2812]

    Research Scientist / Senior Research Scientist (Drug Metabolism) – Simcyp (a Certara company)

    Closing Date for Applications: Midnight (UK time), Sunday 8th January 2017

    Line of Management: Head of Translational Science in DMPK

    Position Type: Fixed Term (Maternity Cover – 12 months)

    Holiday Entitlement: 25 days, plus statutory bank holidays

    Salary: £33,000 - £42,000 per annum dependent on qualifications and experience (plus discretionary bonus, pension contribution, health scheme etc.)

    Location: Sheffield, UK

    Job Overview:

    We have an immediate opening for a Research Scientist / Senior Research Scientist with good working understanding of Physiologically-Based Pharmacokinetic (PBPK) models to cover a period of maternity leave. Candidates should have in-depth experience of gathering and analysing physicochemical, in vitro ADME data and in vivo pharmacokinetic data from literature sources. The post will involve research and development of PBPK models for compounds as well as development of data files containing physiology information on different populations of interest.

    Requirements:

    Essential

    External website http://https://workforcenow.adp.com/jobs/apply/posting.html?client=certara&jobId=12780&lang=en_US&source=CC


    1st Dec 2016 [2811]

    Associate Director/Director, Drug Metabolism-Pharmacokinetics

    Summary:
    The Experimental Pharmacology department is seeking a highly motivated Associate Director/Director of Drug Metabolism-Pharmacokinetics to join our efforts in developing antibody-based therapies that improve outcomes for patients with cancer. The successful candidate will oversee a team that develops innovative bioanalytical assays and critical reagents; designs, implements, and interprets preclinical pharmacokinetics, metabolism, and transporter studies; and writes sections of regulatory submissions and acts as a subject matter expert for interactions with regulators. Integrating DMPK concepts from small and large molecules to inform early research efforts, lead selection, and IND-enabling studies will be key.

    Responsibilities:
    Responsibilities include the design and execution of DMPK strategy for bringing early research candidates to development decisions, and then forward into clinical trials. The successful candidate will have a passion for science and innovation; provide leadership within the department and wider organization; and coach, mentor, and develop DMPK scientists.

    Qualifications:

    Desired: Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

    To apply for this position, please visit http://chp.tbe.taleo.net/chp04/ats/careers/requisition.jsp?org=SEAGEN&cws=1&rid=1812

    External website http://chp.tbe.taleo.net/chp04/ats/careers/requisition.jsp?org=SEAGEN&cws=1&rid=1812


    30th Nov 2016 [2810]

    Research Assistant Professor - DPET The UNC Eshelman School of Pharmacy Position Summary: A Research Assistant Professor position is available immediately to work as part of a multidisciplinary team on infectious disease projects focused on the application of mathematical modeling and simulation to characterize drug pharmacokinetics and pharmacodynamics. The projects will involve the use of nonlinear mixed effects and physiologically-based modeling techniques, and other biostatistical applications in preclinical and clinical drug development research, to identify optimal dosing and clinical trial design. The successful candidate will work in the Clinical Pharmacology and Analytical Chemistry Laboratory of Dr. Angela Kashuba, and will focus on challenging preclinical and clinical modeling projects in the areas of HIV treatment, prevention, and cure. This position is integrated into the UNC Center for AIDS Research and the newly established HIV Cure Center and Qura Therapeutics. This candidate will become part of the Division of Pharmacotherapy and Experimental Therapeutics. This Division is a designated Pharsight Phoenix® Center of Excellence, and is a nationally recognized, dynamic and collegial faculty whose vision is to lead the nation in achieving excellence in innovative translational research, education, and progressive pharmacy practice to optimize drug therapy outcomes. The UNC Schools of Medicine, Public Health, Dentistry, Nursing and Pharmacy comprise one of the nation’s few comprehensive academic health centers located on a world-class research campus. The Division has vibrant fellowship and graduate programs, including an NIH-funded T32 postdoctoral training program in Clinical Pharmacology in collaboration with Duke University and the Hamner Institute for Drug Safety Sciences. Education and Experience Requirements: Qualified candidates must have a doctoral degree in Pharmacometrics, Pharmaceutical Sciences, Biostatistics, Biomedical Engineering, Medicine, Pharmacy or a closely related discipline. The successful candidate must demonstrate expertise in modeling, simulation, and quantitative systems pharmacology. Extensive software (e.g., NONMEM, ADAPT, R) and programming proficiency is preferred. Excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential.

    Application Instruction Qualified applicants should apply at http://unc.peopleadmin.com/postings/110369 and attach the following materials as a single PDF file: a letter of interest addressed to Dr. Angela Kashuba (Search Committee Chair); UNC Eshelman School of Pharmacy, CB# 7569, UNC, Chapel Hill, North Carolina 27599-7569), complete curriculum vitae, name and contact information for 3 professional references, and a detailed research project abstract.

    Hiring Supervisor Angela Kashuba, Pharm.D. Assistant Professor Division of Pharmacotherapy and Experimental Therapeutics UNC Eshelman School of Pharmacy University of North Carolina at Chapel Hill akashuba@unc.edu https://pharmacy.unc.edu/directory/akashuba/

    The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.

    External website http://unc.peopleadmin.com/postings/110369


    Last update: Fri 26 May 2017 12:07:59 pm


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