- Responsible for all aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, 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 and regulatory documents
- Serves as a specialist in PK-PD and Pop PK-PD concepts and independently performs PK-PD analyses, functions as Study Team Leader for Phase 1 Clinical Pharmacology studies, and provides clinical pharmacology input and support for other phase 1-4 clinical studies. Maintains up-to-date knowledge of relevant literature and regulatory guidelines
- 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
- Mentors more junior department members, and provides information sharing within and between departments
- PhD in pharmacology or pharmaceutical sciences or PharmD with a clinical pharmacology research fellowship required
- 7 or more years relevant experience required
- 4 or more years in drug development industrial experience preferred
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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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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
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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
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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 t Clinical, Director, Associate ...
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Associate Director Clinical Pharmacology
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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
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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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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 ...
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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, Clinical Safety MD
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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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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 ...
Director, Quantitative Clinical Pharmacology - Basking Ridge, United States - BioSpace
Description
Job DetailsJoin 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 world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug. This position effectively works independently for all phases of studies and participates in KOL and regulatory interactions at a project level, and interacts with regional and global project team members, senior management, and outside vendors.
Responsibilities
Education Qualifications (from an accredited college or university)