Assoc Dir., Clinical Pharmacology - ImmunoOncology

Location
Tarrytown, NY, United States
Posted
May 29, 2021
Ref
24633BR
Required Education
Bachelors Degree
Position Type
Full time
We are looking for an Associate Director (AD), to support our ImmunoOncology (I/O) efforts in the Clinical Pharmacology (CP) group. We expect the AD to provide support to a Senior Group Director (SGD) within CP, providing strategic and scientific expertise. This person will also represent CP at relevant meetings. This position will provide CP subject matter support to new and ongoing clinical programs.

A DAY IN THE LIFE OF THE AD - CP FOR IMMUNOONCOLOGY MAY LOOK LIKE:
- Act as a Clinical Pharmacology lead to multidisciplinary development teams for I/O programs.

- Develop and maintain comprehensive clinical pharmacology strategic development plans for assigned development programs in collaboration with the SGD.

- Assist in 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.

- In support of Regulatory Affairs, provide clinical pharmacology input towards 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).

- Work closely with Quantitative Pharmacology colleagues to develop and deliver agreed quantitative strategies to support assigned development plans.

- Collaborate with the Pre-clinical PK/PD Team and research teams to achieve business goals

THIS MAY BE THE POSITION FOR YOU IF:
A role with a breadth of diverse leadership exposure including: the ability to influence and collaborate with peers other co-workers to achieve significant outcomes and create business impact is desirable.

IN ORDER TO BE CONSIDERED FOR THIS ROLE YOU MUST:
Have a PhD, ideally in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Pharmaceutics, Immunology, Pharmacology, Engineering, Pharmacy (Pharm.D.) Or Medicine (MD). Additionally, 5+ years of proven experience in CP, clinical PK/PD or Pharmacometrics is required. We expect this experience will enable you to apply the model informed drug development process to clinical drug development; such as use of PK/PD modeling, quantitative systems pharmacology modeling, and exposure-response analysis to support decision making and aid study design.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.