- Responsible for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical pharmacology objectives with high-level supervision; participates in due diligence activities and represents global function on study and project teams
- Produces independent writing for publications & regulatory documents
- Serves as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and can conduct/develop PK-PD and Pop PK-PD analyses,
- Participates in KOL and regulatory interactions at project level, interacts with regional and global study and project team members, and to a limited extent with senior management, and outside vendors; works independently for all phases of studies
- PhD in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years of relevant experience. 1 or more years industry experience required.
- Masters' degree with 6 years of relevant experience. 1 or more years industry experience required.
- Bachelor's degree with 8 years of relevant experience. 1 or more years industry experience required.
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Director, Quantitative Clinical Pharmacology
2 weeks ago
Daiichi Sankyo Basking Ridge, United StatesJob Description · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ou ...
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Director, Quantitative Clinical Pharmacology
2 weeks ago
BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our wo ...
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1 week ago
Regeneron Pharmaceuticals, Inc. Basking Ridge, United States Full timeWe are looking for an Associate Director, within our Clinical Pharmacology group. Providing strategic and scientific expertise, as well as representing Clinical Pharmacology at relevant meetings. This position will provide CP subject matter support to new and on-going clinical pr ...
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Associate Director, Clinical Pharmacology
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Regeneron Pharmaceuticals Basking Ridge, United StatesWe are looking for an Associate Director, within our Clinical Pharmacology group. Providing strategic and scientific expertise, as well as representing Clinical Pharmacology at relevant meetings. This position will provide CP subject matter support to new and on-going clinical pr ...
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Associate Director, Clinical Pharmacology
2 weeks ago
BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting · Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. · Summary · The Associate Director will be responsible for developing and impl ...
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Otsuka Pharmaceutical Co., Ltd. Princeton, United StatesOversees all clinical pharmacology activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Leads study design, execution and reporting of clinical pharmacology and studies. Provides input into all phases of drug development including, but not limited t ...
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Associate Director, Clinical Pharmacology
1 week ago
Regeneron Pharmaceuticals Basking Ridge, United StatesWe are looking for an Associate Director, within our Clinical Pharmacology group. Providing strategic and scientific expertise, as well as representing Clinical Pharmacology at relevant meetings. This position will provide CP subject matter support t Clinical, Director, Associate ...
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Associate Director Clinical Pharmacology
6 days ago
BioSpace, Inc. Basking Ridge, United StatesJob Details · The Associate Director will provide strategic and scientific expertise, as well as represent Clinical Pharmacology at relevant meetings. This position will provide CP subject matter support to new and ongoing clinical programs primarily in the Oncology area. · Thi ...
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Associate Director, Clinical Pharmacology
1 week ago
Regeneron Pharmaceuticals Basking Ridge, United StatesWe are looking for an Associate Director, within our Clinical Pharmacology group. Providing strategic and scientific expertise, as well as representing Clinical Pharmacology at relevant meetings. This position will provide CP subject matter support to new and on-going clinical pr ...
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Associate Director, Clinical Pharmacology
2 weeks ago
Daiichi Sankyo, Inc. Basking Ridge, United StatesJoin a Legacy of Innovation 110 Years and Counting · Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. · Summary · The Associate Director will be responsible for developing and implementing Clini ...
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Director, Quantitative Clinical Pharmacology
3 days ago
Daiichi Sankyo Basking Ridge, NJ, United StatesJoin a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science ...
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Medical Director, Clinical Pharmacology
2 weeks ago
Novartis AG East Hanover, United StatesAbout the Role · This role will be located on-site at our East Hanover, NJ or Cambridge, MA campus and will not have the ability to be located remotely (East Hanover, NJ preferred). · About the role: · Novartis Biomedical Research (NBR) is the innovation engine of Novartis, focus ...
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Associate Director, Clinical Pharmacology
3 weeks ago
Daiichi Sankyo, Inc. New Jersey, United StatesJoin a Legacy of Innovation 110 Years and Counting · Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. · Summary · The Associate Director will be responsible for developing and implementing Cli ...
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AstraZeneca New York, United StatesSenior Director, Clinical Pharmacology & Quantitative Pharmacology (CPQP) - ADC · Introduction to role: · Are you ready to make a meaningful impact on patients' lives? We are seeking a Senior Director for our Clinical Pharmacology & Quantitative Pharmacology (CPQP) team within t ...
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Director/Sr. Director, Clinical Pharmacology
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Zentalis New York, United StatesJob Description · Job DescriptionSalary: $222-264k · JOB SUMMARY: · Serves as the primary clinical pharmacology lead providing clinical pharmacology, translational and quantitative clinical pharmacology expertise to a multidisciplinary study team. Responsible for programs in cli ...
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Medical Director, Clinical Pharmacology
4 weeks ago
Novartis AG East Hanover, United StatesAbout the Role · This role will be located on-site at our East Hanover, NJ or Cambridge, MA campus and will not have the ability to be located remotely (East Hanover, NJ preferred). · About the role: · Novartis Biomedical Research (NBR) is the innovation engine of Novartis, focus ...
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Genmab Princeton, United StatesJob Description · At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people ...
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Columbia University New York, United StatesThe Clinical Pharmacology and Toxicology Laboratory (CPTL) in the Department of Pathology & Cell Biology at Columbia University Irving Medical Center is a CLIA-certified laboratory that develops High Performance Liquid Chromatography and quantitative mass spectrometry-based assay ...
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Johnson & Johnson Somerville, United StatesJob Description · Janssen Research & Development, LLC is recruiting for an Associate Director, Clinical Pharmacology and Pharmacometrics (CPP) to be located in Spring House, PA, Titusville, NJ or Raritan, NJ. · At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are ...
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Merck Rahway, United States**Job Description** · **Job Responsibilities:** · + Primary responsibility is writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to support the development of therapeutic agents and vaccines. · + This includes but is not limit ...
Associate Director, Clinical Pharmacology - Basking Ridge, United States - Daiichi Sankyo
Description
Job DescriptionJoin a Legacy of Innovation 110 Years and Counting
Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.
Summary
The Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration.
Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/ Quantitative Clinical Pharmacology function.
The incumbent will champion model-based drug development as an active team member of clinical and development teams.Responsibilities
Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education (from an accredited college or university) and Experience Qualifications
One of the following is required:
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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