- Develop and maintain comprehensive clinical pharmacology strategic development plans for assigned development programs.
- Provide clinical pharmacology subject matter expertise to the Clinical Study Team/ Development Team.
- Participate in the drafting and finalization of clinical study protocols and study analysis plans (SAP).
- Conduct and/or supervise pharmacokinetic / pharmacodynamic analyses.
- Draft, finalize, and/or review clinical pharmacology study reports and publications. Work with the Medical Writing Team to incorporate PK/PD sections into clinical study reports.
- Work closely with Regulatory to provide 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 summary sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings).
- Collaborate with Quantitative Pharmacology colleagues closely to develop and deliver agreed quantitative strategies to support assigned development plans.
- Collaborate with the Pre-clinical PK/PD Team as needed.
- Want the ability to make a significant impact on the organization and external groups and can influence and effect change.
- Enjoy making contributions to multi-disciplinary meetings by sharing cross-functional skills and knowledge.
- Want to work in cross-functional teams with forward-thinking, passionate, and driven teammates
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Associate Director, Clinical Pharmacology - Tarrytown, United States - Regeneron
2 weeks ago
Description
We 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 programs primarily in the Oncology area.
This role must be onsite a minimum of 3-days per week at either our Tarrytown, NY or Basking Ridge, NJ location.
A day in the life an Associate Director may look like:
This may be the right role for you if you:
In Order to be considered qualified for this role you must have:
A PhD, Biology, Pharmacology, Engineering, Pharmacy (Pharm.D.), Medicine (MD) and at least 5 years of relevant Clinical Pharmacology experience. Oncology experience is strongly preferred, but not required.
