Principal Clinical Pharmacologist - ImmunoOncology

Regeneron Pharmaceuticals; United States; Remote; USD 148,000 - 242,000; Full time

Job summary

An established industry player is seeking a highly motivated Principal Scientist in Clinical Pharmacology to join their Pharmacometrics group. This pivotal role involves developing strategic plans, collaborating with cross-functional teams, and providing regulatory support for clinical programs. The ideal candidate will possess a PhD in a relevant field and have significant experience in Clinical Pharmacology, ideally with a focus on oncology. This innovative firm fosters a diverse culture and offers comprehensive benefits, including wellness programs and equity awards, making it an exciting opportunity for passionate scientists eager to make a difference in the field.

Benefits

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Qualifications

• PhD in relevant field and at least 4 years of Clinical Pharmacology experience.
• Oncology experience preferred but not required.

Responsibilities

• Develop and maintain strategic CP development plans for assigned programs.
• Collaborate with teams to characterize preclinical PK/PD and accelerate clinical studies.
• Draft and review clinical study protocols and analysis plans.

Skills

Clinical Pharmacology

Communication Skills

Strategic Planning

Collaboration

Scientific Writing

Education

PhD in Biology

PhD in Pharmacology

PhD in Engineering

PhD in Pharmacy (Pharm.D.)

MD

Job description

We are looking for a highly motivated Principal Scientist, Clinical Pharmacology in our Pharmacometrics (PMx) group. The position will report to the Senior Group Director (SGD) within Clinical Pharmacology (CP.) You will represent CP on project teams to provide strategic and scientific expertise to support new and ongoing GM clinical programs. This individual is expected to provide significant contributions to PMx deliverables for multiple programs to support the strategies for each program. In addition, this person will prospectively contribute to longer-term development strategies executed over the course of multiple non-clinical experiments, clinical studies and PMx analyses. You will conduct or otherwise oversee the development of PMx analysis plans.

A typical day as a Clinical Pharmacologist looks like:

• Develop and maintain comprehensive strategic CP development plans for assigned programs with SGD supervision.
• Provide CP subject matter expertise and presentations to the Clinical Study Team/Development Team and Senior Management/Governance meetings with SGD supervision.
• Collaborate and assist the Pre-clinical PK/PD Team and research teams to characterize preclinical PK/PD for prediction human PK/PD to accelerate clinical studies and achieve business goals.
• Assist in drafting and finalization of clinical study protocols and study analysis plans.
• Draft, finalize, and/or review CP reports.
• Collaborate with the Medical Writing Team to incorporate PK/PD sections into clinical study reports.
• Provide CP support of regulatory documents, communications, and presentations (eg, IND, health authority queries, preparation of BLA summary sections, addressing review inquiries) with SGD supervision.
• Represent CP at pre-IND, Type C, preBLA, and other health authority meetings with SGD supervision.
• Work closely with Quantitative Pharmacology to develop quantitative strategies and to deliver analyses and technical reports to support strategic development plans.
• Actively publish work in scientific literature.

This role may be for you if:

• Have strong communication skills to actively engage colleagues cross-functionally at all levels of the organization, innovative and flexible mindset, keen scientific interest and solid science background are required.
• Have a passion for science.

In order to be considered qualified for this role: A PhD in Biology, Pharmacology, Engineering, Pharmacy (Pharm.D.), Medicine (MD) and at least 4 years of relevant Clinical Pharmacology experience. Oncology experience is strongly preferred, but not required.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Salary Range (annually)

$148,300.00 - $241,900.00