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Associate Director/Director, Clinical Pharmacology
If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA (R) (aflibercept) Injection, ZALTRAP (R) (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST (R) (rilonacept) Injection for Subcutaneous Use. Regeneron has filed a regulatory application with the U.S. Food and Drug Administration (FDA) for a second indication for EYLEA. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.
This individual will assume a leadership role in the Clinical Pharmacology Department. This position will provide direct support to the Sr. Director of Pharmacometrics providing strategic and scientific input to the Clinical Pharmacology operation as well as corporate wide representation. Will also provide strategic, tactical, and CP subject matter support to new and on-going clinical programs.
Responsibilities will include:
Provide clinical pharmacology/pharmacokinetic subject matter expertise to the Clinical
Study Team/ Joint Development Team.
Assist in the leadership of the Clinical Pharmacology Department, and directly manage other CP professionals
Participate in the drafting and finalization of clinical study protocols and study analysis plan (SAP).
Develop and maintain program specific and comprehensive clinical pharmacology strategic development plan.
Work with the Translational Medicine Team to conduct and analyze biomarker and pharmacokinetic data to establish a PK/PD relationship.
Work closely with the Regulatory to clinical pharmacology support of regulatory documents, communications and presentations as needed (IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of BLA summery sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings).
Conduct pharmacokinetic analysis.
Draft, finalize, and/or review clinical pharmacology/pharmacokinetic study report. Work with the Medical Writing Team to incorporate the PK/PD sections of the clinical study report (CSR).
Assist the Pre-clinical Pharmacokinetics Team as needed.
Pharmacokinetics, Biology, Biochemistry, Pharmacology,
Toxicology, Pharmacy (PharmD), or Medicine (MD).
In-depth understanding and proficiency in pharmacokinetic and PK/PD analyses is a must Strong understanding of the fundamental and underlying sciences associated with clinical pharmacology Ability to integrate biological systems, physiology, pharmacology, and biochemistry with PK/PD and drug development. Demonstrated ability to move drug candidates through the development process. Manage multiple programs with competing and aggressive time lines, prioritize activities, work independently, and manage a team of Clinical Pharmacology professionals
In depth theoretical and applied understanding of Clinical Pharmacokinetics.
Experienced in non-compartmental and population pharmacokinetic, and Pharmacodynamics analysis.
Experience in drug development of protein therapeutics through BLA submission, review and post marketing commitments.
Experienced in drafting/reviewing CP/pharmacokinetic reports, CP support of: clinical protocol development, IND/, BLA's.
Excellent communication (written and verbal) and interpersonal skills is a must.
Understanding of the applicable FDA /EMA /ICH regulations and guidance's.
We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.
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