PK/PD and Other Jobs

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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


    Contact email address: jmochel@iastate.edu - 18th Nov 2016 [2809]

    The College of Veterinary Medicine at Iowa State University invites applications for a PhD position in Pharmacology Modeling and Simulation (M&S) within the Department of Biomedical Sciences (BMS).

    In this position the individual will develop and apply mathematical models that are relevant to the field of Pharmacokinetics and Pharmacodynamics for predictions of drug exposure and response in multiple animal species.

    The focus of the applicant’s research will pertain to the analysis of experimental and clinical data obtained from spontaneous animal models of human diseases with a special focus on oncology, internal medicine (e.g IBD research), cardiology and infectious diseases.

    There is an increasing need for advanced M&S-based pharmacology in Veterinary Medicine, to better confirm the key pharmacokinetic and pharmacodynamic characteristics of a drug candidate, with the goal of providing explicit, reproducible, and predictive evidence for optimizing drug development plans, enabling critical decision making, and eventually bringing safe and effective medicines to patients.

    Required Education and Experience
    Successful candidates should have a master’s degree in Pharmacometrics, Mathematics, Biostatistics, or other related fields (including Bioengineering and Bioinformatics). The candidate should have at least a basic understanding of nonlinear mixed-effects (population) models with solid programming and software proficiency including but not restricted to: R, SAS, Monolix or NONMEM, SimBiology, Matlab, Gastroplus or SimCYP. Excellent organizational, communication and computer skills are required.

    Interested individuals should submit an up-to-date resume to Dr. Jonathan P. Mochel at jmochel@iastate.edu (515-294-7424).

    Learn more about our PhD program and admissions standards here.

    Complete our free, preliminary application today!

    External website http://https://vetmed.iastate.edu/bms


    Contact email address: careers@ranarx.com - 17th Nov 2016 [2808]

    Head of Pharmacokinetics and Drug Metabolism

    We are seeking a highly motivated and scientifically rigorous individual to join RaNA and lead our PKDM efforts. The successful candidate will report to Head of Translational Development and will be an integral part of the Research and Development team.

    Summary of Role

    The Head of Pharmacokinetics and Drug Metabolism (PKDM) is responsible for providing PKDM strategy, expertise, representation and resources to all program teams and RaNA management across all therapeutic areas and stages of development. S/he will provide leadership and oversight of the PKDM group and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to generate and integrate PK and ADME data leading to the estimation of safe and efficacious first in human clinical dose and regimen for novel therapeutics, as well as predicted clinical PK and PK/PD profiles and optimal posology. In addition, the PKDM organization will be responsible for design, analysis and reporting for all phase-appropriate and registration-enabling studies (eg, bioavailability, ADME, bioequivalence, DDI, food-effect). The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with program-related PKDM issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Head of PKDM develops and implements strategic plans for preclinical and clinical pharmacokinetics and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for PKDM studies and other activities in support of RaNA portfolio programs, and provide submission-ready documentation for the PKDM components of regulatory submissions.

    Requirements

    To apply, please email your CV to careers@ranarx.com.

    RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA has a competitive employee benefits package that includes health/dental insurance, 401K retirement plan and company match, paid vacation, and much more!

    External website http://ranarx.com/be-fearless/


    Contact email address: Jeffrey.Tworzyanski@fda.hhs.gov - 15th Nov 2016 [2807]

    Position Description:

    The Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD) of the Food and Drug Administration has Oak Ridge Institute for Science (ORISE) fellow positions available.

    DQMM provides expertise in advanced quantitative methods for the generic drug program and conducts GDUFA (Generic Drug User Fee Amendments 2012) regulatory science and research activities based on quantitative approaches, which include guidance development, abbreviated new drug application (ANDA) reviews, citizen petitions, controlled correspondence, pre-ANDA meetings, and methodology development for bioequivalence evaluation, active ingredient sameness demonstration and post marketing safety surveillance. This Division coordinates modeling, simulation, data analysis and data mining and establishes the scientific computing infrastructure for OGD. DQMM is also developing innovative quantitative approaches to improve regulatory decision making for generic drugs by fully utilizing the large amount of data available to FDA. The ORISE position(s) at DQMM provides an outstanding opportunity to learn and apply quantitative analysis, modeling, and simulation to support the aforementioned activities.

    Research at DQMM includes, but not limited to, the following areas:

    Qualifications: For ORISE positions, the initial appointment is for one year.

    Location: Silver Spring, MD
    Contact: Send CV to Jeff Tworzyanski.
    Jeffrey.Tworzyanski@fda.hhs.gov

    Applications should be sent by 12/10/2016 to receive full consideration.


    Contact email address: George.Peterson@regeneron.com - 3rd Nov 2016 [2806]

    Regeneron Pharmaceuticals: 2 NEW openings Scientist - Senior Staff Scientist, Clinical Pharmacology:

    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.

    Regeneron is seeking a Clinical Pharmacology (CP) Scientist who is well versed in the application of pharmacokinetics / pharmacodynamics (PK/PD), in order to describe and understand the pharmacology/biology of therapeutic proteins. The candidate will work with the CP-Therapeutic Area Lead to execute CP strategies that will contribute to the development of Regeneron’s deep clinical pipeline. The candidate will be the point of contact for CP on cross functional development project teams and will be an advocate for the use of quantitative approaches in drug development to better describe the relationship between the known physiology, physico-chemical properties and the observed pharmacokinetics. This role will require a high level of collaboration, both within Regeneron and externally. This role will involve the preparation and presentation of PK/PD analyses to internal project teams, management, external partners, regulatory agencies and investigators. The candidate must have the ability to influence, with strong communication and leadership skills. The candidate will be expected to share her/his opinions, ask and answer challenging questions, and demonstrate tenacity, all in the context of excellent science, as Regeneron continues to create innovative new medicines.

    Responsibilities:

    Experience and Required Skills: 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 and 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.

    To learn more, we are delighted to invite you to view and apply to the openings at careers.regeneron.com.

    Create The Future You Believe In

    External website http://careers.regeneron.com


    3rd Nov 2016 [2805]

    A postdoctoral research position is available immediately to work on projects focused on the application of mathematical modeling to characterize the pharmacokinetic/pharmacodynamic properties of drugs in the pediatric population. The projects will involve use of nonlinear mixed effects and physiologically-based modeling techniques to identify optimal pediatric dosing and clinical trial design. Requirements: minimum of a PharmD, MD, or PhD with knowledge of PK/PD analyses. Preferred Experience: extensive software proficiency, including NONMEM and R or SAS, is preferred. Excellent 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/108568

    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/108568


    31st Oct 2016 [2804]

    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:

    1. Your curriculum vitae,
    2. Your letter of interest.. The letter of interest should explain your qualifications for the position.
    3. 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


    24th Oct 2016 [2803]

    Senior Scientist – Bioanalytical DMPK

    Overall responsibility: The Preclinical Development team seeks an experienced Bioanalytical Sr. Scientist to provide bioanalytical support to the Preclinical Development team. The ideal candidate will be highly skilled in the development, optimization, and implementation of bioanalytical methods to drive the ADME, PK, and PK/PD characterization of drug candidates. He or she will have experience analyzing DMPK data and interpreting results to effectively guide candidate selection. He or she will serve as a DMPK representative in interdisciplinary collaborations and communicate conclusions, progress, and plans at internal meetings. Experience with peptidomics/proteomics and orally delivered peptides/proteins is highly desirable.

    Key tasks and responsibilities:

    Education and Experience: Degree in drug metabolism, biochemistry, pharmacology or other related field. PhD with 3+ years or MS with 5+ years of experience in a pharmaceutical industry setting.

    If interested, we would welcome a cover letter and CV sent to careers@axcellahealth.com No phone calls please, and only those we will be following up with, will receive a reply. Visit our website and learn more about us www.axcellahealth.com

    External website http://careers@axcellahealth.com


    21st Oct 2016 [2802]

    General Scope and Summary

    SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role in the DMPK group. The candidate will serve as the DMPK representative on various discovery and development project teams to ensure effective application and integration of ADME, PK, and PK/PD studies in support of discovery and development programs at SAGE.

    Roles and Responsibilities

    Experience, Education and Specialized Knowledge and Skills

    External website https://careers-sagerx.icims.com/jobs/1103/senior-scientist%2c-dmpk/job?mode=view


    Contact email address: laurie.rose@agios.com - 21st Oct 2016 [2801]

    Sr. Scientist, DMPK-Clinical Bioanalytical

    Agios Pharmaceuticals is focused on discovering and developing novel drugs to treat cancer and inborn errors of metabolism, or IEMs, which are rare genetic metabolic diseases, through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across both therapeutics areas, Agios has multiple first-in-class lead product candidates in cancer metabolism and IEMs in clinical and/or preclinical development. All Agios programs focus on genetically identified patient populations, leveraging our knowledge of metabolism, biology and genomics.

    Position and Responsibilities Summary:

    Skills/Knowledge Required: To apply for this position, please visit: http://www.agios.com/careers-overview.php

    External website http://www.agios.com


    Contact email address: bcostello@c4therapeutics.com - 21st Oct 2016 [2800]

    DMPK, Senior Research Scientist

    Overview:

    Ideal candidate will integrate with Chemistry, Biology, Discovery, and Translational Science groups as part of cross-functional project teams to provide scientific, technical and operational DMPK support on programs from Hit to Lead through candidate molecule selection and clinical evaluation. This includes identifying ADME/PK issues, co-developing strategies to evolve clinical candidate molecules, and managing ADME, PK, PK/PD assay development/work flow at C4 Therapeutics and with external parties.

    Responsibilities:

    Qualifications

    External website http://c4therapeutics.com/overview-2/jobs-3/senior-research-scientist-dmpk/


    20th Oct 2016 [2799]

    Certara Strategic Consulting is looking for talented and motivated Pharmacometricians/ Clinical Pharmacologists to join our UK, EU, and US teams!

    The Associate Director/Director level Pharmacometrician candidates will be a recognized expert in applied Population PK and PK/PD modelling and simulation to help design and conduct PK/PD modelling and simulation to support drug development.

    The Associate/Director level Clinical Pharmacologists will be recognized applied development practitioners, experienced in both design and stewardship of clinical pharmacology components of clinical development plans and optimal application of pharmacometric approaches to support decision making.

    Our Pharmacometricians/Clinical Pharmacologists are responsible for providing quantitative/ clinical pharmacology expertise into clinical development plans, including the design, conduct and interpretation of relevant clinical pharmacology studies, including PKPD studies. Our Associate Directors and Directors support projects for Certara's clients by working in teams with other Associates, (Expert) modelers, and drug development consultants. The qualified candidate will have the ability to work on a variety of therapeutic indications and data types, and may supervise and provide oversight of Associates.

    REQUIREMENTS

  • Pharmacometricians: Ph.D. or equivalent degree in pharmacometrics, pharmaceutical sciences, mathematics or similar disciplines
  • Clinical Pharmacologists: PharmD, PhD, MD or equivalent degree
  • Minimum of 5 years’ experience in drug development with experience in serving as a functional representative (Pharmacometrics or clinical pharmacology) on drug development project teams
  • Expertise in PK/PD and clinical pharmacology with strong quantitative skills
  • Good knowledge of modelling software such as WinNonlin Phoenix, NONMEM, S-Plus/R
  • Ability to work across functions to implement company initiatives
  • Ability to mentor other junior PK scientists staff on clinical pharmacology science and strategy
  • Proficient in spoken and written English
  • Excellent verbal and written communication skills
  • Excellent interpersonal skills and a team player
  • WORKING AT CERTARA

    We have a preference for working together through office-based locations, but partially working from home is feasible. Certara is looking for candidates who want to:

    US based candidates should apply via our careers portal. All non US based applicants should send their resume and cover letter to shuman.resources@certara.com.

    External website http://https://workforcenow.adp.com/jobs/apply/posting.html?client=certara&ccId=19000101_000001&type=MP&lan


    4th Oct 2016 [2796]

    (Senior) Scientist (m/f) PK/PD Modeling & Pharmacometrics Reference number 154-2016

    MorphoSys AG in Martinsried near Munich, Germany

    www.morphosys.com/careers

    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/careers


    Contact email address: simcyp.recruitment@certara.com - 28th Sep 2016 [2794]

    Research Associate / Scientist (System Toxicology) – Simcyp (a Certara company)

    Closing Date for Applications: Midnight (UK time), Sunday 30th October 2016

    Line of Management: Head of Systems Modelling

    Position Type: Full Time (5 year fixed term contract)

    Holiday Entitlement: 25 days, plus statutory bank holidays

    Salary: £28,000 - £32,000 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 / Scientist with good working understanding of computational systems biology. Candidates should have in-depth experience of literature data gathering and simulation of molecular interaction networks. Ideally this should be in mammalian cell biology, toxicology or pharmacokinetics-pharmacodynamics. Experience with constrained based modelling of genome scale metabolic networks and/or analysis of ~omics data will be an advantage.

    Requirements:

    Essential

    For full details and to apply please visit our website

    External website http://https://www.certara.com/contact-us/careers/


    15th Sep 2016 [2792]

    Senior Manager, Pharmacokinetics, Dynamics & Metabolism POS_75089281-1

    Description

    Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.

    Sanofi US

    At Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health.

    Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company dedicated to discovering, developing and distributing therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.

    Sanofi US employs approximately 17,000 people across the country all dedicated to protecting health, enhancing life and responding to the hopes and potential healthcare needs of seven billion people around the world.

    Commitment is our Strength. Ready to grow together?

    Sanofi US endeavors to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-800-207-8049 Option 7, then Option 3.

    Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

    JOB INFORMATION Job title: Senior Manager Function: Translation Medicine and Early Development (TMED) Department: Pharmacokinetics, Dynamics, and Metabolism (PKDM) Location: Bridgewater

    JOB SUMMARY Support project teams as a modeling and simulation (M&S) and/or pharmacokinetics, dynamics, and metabolism (PKDM) expert Conduct PK, population PK, PK/PD analysis, clinical trial simulation, and/or PBPK analysis; Formulate and execute PK/PD and M&S strategies for specific projects; Develop and review protocols, analysis plans, and study reports for M&S aspects; Prepare IB/IMPD/IND and other regulatory documents, when needed. Develop the following scientific skills: Perform population PK and PK/PD analysis, clinical trial simulation, and/or PBPK analysis under minimal supervision; Perform compartmental PK analysis and simulation; Perform complex non-compartmental PK analysis; Apply a logical and structured approach to file management; Accurately and fully record pharmacokinetic analyses in an auditable manner consistent with GLP practices, where applicable; Develop departmental procedures (SOP’s, Protocols, Safety Procedures); May train/mentor others. Demonstrate the following scientific competencies: Serve as PKDM representative for projects, especially in the area of M&S; Can recommend a course of action to solve M&S issues and may be responsible for its implementation; Can act as a resource to address technical and theoretical issues in the M&S area; Be able to operate in a multicultural environment and participate in international teams; Understand the general scientific basis of protocols and overall study objectives as related to assigned studies; Participate in the preparation of protocols and/or analysis plans; Prepare and issue preliminary notes, key results summaries, CSR sections, and stand-alone M&S reports with minimal review; Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA; Can represent Sanofi to regulatory agencies; Participate and/or present at departmental, external and international meetings within the company; Prepare abstracts, posters and manuscripts for presentation and/or publication; Present at external scientific meetings as appropriate; Identify skill-sets necessary to advance career development. Ensure that all assigned project activities are performed in compliance with current departmental SOP’s, guidelines, industry best practices and regulatory guidelines, and are conducted following acceptable scientific rationale: Possess excellent interpersonal communications skills commensurate with working in a multicultural organization; Demonstrate a proficiency at scheduling multiple activities; Monitor compliance with any appropriate Sanofi guidelines; Independently accountable for meeting project timelines.

    Qualifications

    Formal education and experience required: Technical expertise in several of the following areas: population PK and PK/PD modeling, Clinical trial simulation, PK/PD modeling and simulation, PBPK modeling, and: Ph.D. with or without post-doctoral experience in a biological, chemical, mathematical, computer science or closely related discipline plus at least 6 years of relevant experience; Equivalent theoretical and technical knowledge

    External website https://sanofi.taleo.net/careersection/external/jobdetail.ftl?job=POS_75089281-1&src=SNS-10723


    15th Sep 2016 [2791]

    Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.

    DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS\\\'s mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory. Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!

    Job Summary:
    Dart NeuroScience LLC is seeking an experienced DMPK scientist to conduct, lead and manage in vitro ADME studies supporting the identification and development of clinical candidates. The position will involve the conduct of a variety of in vitro ADME experiments including microsomal and hepatocyte stability, enzyme kinetic assays, Cytochrome P450 reaction phenotyping and inhibition assays, and strategies to detect non-Cytochrome P450-mediated pathways. A thorough understanding of the theoretical and technical aspects of drug metabolizing enzymes and applications to in vitro drug-drug interaction studies is required. Knowledge and experience with HPLC and mass spectrometry is required. The successful candidate must have solid technical skills and the ability to supervise and mentor others in the group. Strong knowledge of FDA guidance documents and GLP practices a plus. This position requires the successful candidate to generate, analyze results and to provide oral and written presentations of the data.

    Qualifications/Requirements:

    Benefits:
    DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan.

    Reference Job Code 13-038 #775308 when applying.

    External website http://www.recruitingsite.com/csbsites/dartneuroscience/JobDescription.asp?SuperCategoryCode=15701&J


    12th Sep 2016 [2790]

    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:
    An advanced degree (PhD or PharmD) in a chemical, biological, pharmaceutical, or related field with at least 8 years of experience All levels of experience will be considered and the title will be commensurate with the candidate's experience and accomplishments Experience with large and small molecule PK/ADME and bioanalysis Experience with investigation of drug metabolism, transporters, and biotransofrmations of therapeutics Experience with PK analysis software such as WinNonLin Experience with contributing to INDs and other regulatory submissions, as well as interaction with regulators Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting

    Desired:
    Publications and conference presentations on PK/ADME and bioanalysis Laboratory experience with mass spectrometry, affinity purification, and ligand binding assays. Experience with PK/PD modeling Understanding of clinical pharmacology and its integration with preclinical investigation and strategy

    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.

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


    Contact email address: tim.brady@biogen.com - 26th Aug 2016 [2789]

    The Sr. Pharmacometrician serves as the Quantitative Pharmacology lead on early program teams providing strategic leadership and execution of Quantitative Pharmacology plans that include characterization of the Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) of the drug candidate This person also oversees development and application of Systems Pharmacology models, providing rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment should be considered.

    Responsibilities:

    *LI-SRC6 Location Cambridge, MA, US Job Category Research Requisition Number 27411BR

    Qualifications

    External website http://https://jobs.biogen.com/job/Cambridge-Assoc-Director%2C-Quantitative-Pharmacology-MA-02138/324739500


    Contact email address: George.Peterson@regeneron.com - 24th Aug 2016 [2788]

    Sr. Statistical Programmer, Pharmacometrics Req# 7576BR Regeneron Pharmaceuticals Location: Tarrytown, NY (30 minutes from NYC)

    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.

    Summary:
    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.


    Responsibilities: 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, 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: Experience and Required Skills:
    1. Prior experience in successful regulatory NDA/BLA submissions.
    2. Background in creating SDTM and ADaM data sets in SAS.
    3. Well experienced in SDTM and ADaM data set validation.
    4. Well experienced Generate and validate TLF.
    5. Experienced in in generation and validation of NONMEM data sets for Pop PK and PK/PD.
    6. Experienced in generation of high quality graph in SAS and/or R
    7. Experienced in creation of exploratory PK and PK/PD data set from LIMS and clinical raw data sets.
    8. Prior experience in support of Clinical Pharmacology, modeling & simulation, and other pharmacometric activities.
    Bachelors degree +7 years experience or Masters degree +4 years experience

    TECHNICAL SKILLS:

    If interested, please apply online and/or reach out to me directly at George.peterson@regeneron.com for more info

    External website http://www.careers.regeneron.com


    Contact email address: jchapman@haallc.com - 19th Aug 2016 [2787]

    Director/Senior Director DMPK

    Job Description
    Seasoned leader, responsible for overseeing all DMPK programs.

    Responsibilities
    Represent DMPK on cross-functioning teams. Create and execute DMPK strategies and overall vision for the teams. Serve as the lead, coach, and mentor to the scientists in support of preclinical and clinical DMPK and PK/ADME activities. Oversee data analysis and modeling in support of dosage prediction and exposure. Ensure regulatory compliance in the team (INDs, NDAs, among others).

    Job Requirements
    Ph.D. in Drug Metabolism, Pharmacokinetics, or related field with 10+ years of industry experience. Seasoned and current DMPK leader. Extensive knowledge of DMPK and PK principles and practices. Regulatory experience required. Exceptional leadership and communication skills are required.

    Interested?
    Send a current copy of your CV and/or any questions you may have to Jay Chapman, jchapman@haallc.com.


    Contact email address: ldzwart@its.jnj.com - 18th Aug 2016 [2786]

    Pharmacokinetics, Dynamics and Metabolism (PDM) is a department of Preclinical Development and Safety within Janssen Research & Development, a division of Janssen Pharmaceutica N.V. Pharmacokinetics, Dynamics and Metabolism investigates the absorption, distribution, metabolism and excretion of new drugs in development.

    In the PDM Department, Beerse site (Belgium), a position is available for a (SENIOR) SCIENTIST Pharmacokinetics

    Job Description:
    This person will serve as a key scientific contributor in the Pharmacokinetics, Dynamics and Metabolism Group, providing pharmacokinetics expertise to project teams, toxicologists and other functional areas (Quantitative Sciences, PDMS) as required. This person will be responsible for the design, conduct and interpretation of mechanistic in vivo and in vitro pharmacokinetic studies and employ latest preclinical PBPK/PD models for the projection of human exposure profiles as well as for the early identification of development risks/opportunities. Additional responsibilities include protocol design/input for (hypothesis driven) Pharmacokinetics/Toxicokinetics studies, evaluating data and authoring company reports.

    The incumbent will represent the department at various working group meetings to address PK/TK and ADME-related issues, and provide guidance on the appropriate use of this data for decision making purposes about compound progression.

    Qualifications :
    PhD in a relevant life science discipline A fundamental understanding of drug discovery and development and the role of pharmacokinetics. In-depth training and hands-on experience in pharmacokinetics and knowledge in mechanistic PK-PD (TK-TD) modeling Additional experience in absorption, distribution, drug metabolism, enzyme kinetics and transporter research is highly desirable. Ability to design, supervise and interpret various types of mechanistic ADME/PK and TK studies Proficiency in the development/optimization of new/existing experimental models to support hypothesis driven pharmacokinetic research. Prior experience with PK analysis (non-compartment & multi-compartment modeling) and a demonstrated ability to work with modeling tools (e.g. NONMEM, Phoenix, GastroPlus, SimCYP). Active scientific participation and collaboration with colleagues in industry, academia and regulatory agencies. Strong analytical thinking, excellent communication skills and the proven ability to work independently as well as effectively within a team environment Excellent oral and written communication skills in English

    External website https://jobs.jnj.com/jobs/1600113358W/Senior+Scientist+Pharmacokinetics?lang=en-US


    Contact email address: wolfgang.schmider@sanofi.com - 16th Aug 2016 [2784]

    Location: Germany – Frankfurt

    Who We Are
    Sanofi is a world-leading healthcare company. More than 110,000 employees work in the service of health in over 100 countries worldwide. They research, develop and market therapeutic solutions with the aim of improving the lives of humans. Germany is one of the company’s key sites after the USA and its home market France. Of the ten largest pharmaceutical companies in the world (in terms of market value), Sanofi is the only company in Germany which covers the whole value chain of the pharmaceutical business and is engaged in both significant research and production at its German site.

    Your responsibilities

    Your qualifications Our Offer If you are interested, please send us your online application.

    External website https://recruiting.sanofi.de/cms/de/karriere/stellenangebote/job-detailansicht.html?jobDbId=516181&j


    Last update: Thu 16 Feb 2017 04:14:26 pm


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