Open Positions: Senior Research Investigator/ Associate Director, Clinical Pharmacologist
Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and “undruggable” targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.
The lead Clinical Pharmacology representative will be a critical link with program team members, investigators, and key opinion leaders in the external Clinical Pharmacology community. The incumbent will work closely with these subject matter experts, developing clinical pharmacology strategy, designing clinical pharmacology studies, and providing inputs into identifying appropriate clinical pharmacology investigators/CROs for these studies. This individual will serve as a key Clinical Pharmacology strategic and point person at program teams and leading efforts to analyze and present pharmacokinetic and pharmacodynamic data from clinical studies. The selected individual will work closely with other physicians, scientists, regulatory professionals, statisticians and members of the clinical operations department to carry out these responsibilities. The individual will respond to inquiries by practitioners and investigators, IRBs, regulatory bodies, and vendors on Clinical Pharmacology related questions. This person will work to establish relationships with key Clinical Pharmacology opinion leaders, external Clinical Pharmacology advisors and collaborators.
This position reports to our Executive Director, Clinical Pharmacology and may be performed from our headquarters in New Haven, CT or as a remote role based from within the U.S.
Key responsibilities include, but are not limited to:
- Serve as the lead clinical pahrmacology representative at program team by collaborating with subject matter experts in Clinical Research, DMPK, Regulatory, CMC, Toxicology, Research, Pharmacology to progress clinical compounds from preclinical through all phases of clinical development, in a program team setting.
- Develop and implement clinical pharmacology strategy; design and execute clinical Pharmacology studies, and accountable for the analysis of pharmacokinetic and pharmacodynamic data.
- Responsible for clinical pharmacology and clinical research report writing and review, using his/her clinical pharmacology expertise to identify ways to best analyze and present pharmacokinetic and pharmacodynamic data in a complete, accurate and scientifically sound manner.
- Publish, evaluate and assess clinical pharmacology publications (abstracts, posters, manuscripts).
- Senior Research Investigator/Associate Director: 8+ years of clinical drug development experience in industrial, academic, or regulatory settings; successful in implementing clinical pharmacology studies; track records of high impact publications and/or presentations at premier clinical pharmacology meetings; track records of successful delivering clinical pharmacology-responsible regulatory submissions such as the IND or NDAs, and with other global regulatory agencies such as EMA, PMDA or TGA.
- Excellent oral and written communication skills for effectively interfacing with internal and external collaborators.
- Proficient in integrating model-informed drug development approach to enhance program team decisions.
- Track records of applying advance pharmacokinetic and pharmacodynamic modeling software such as NLME, NONMEM, Gastro-Plus or SYMCYP to support program decision is highly desirable.
- Doctor of Pharmacy (Pharm.D), Doctor of Pharmaceutical Sciences (PhD), Doctor of Medicine degree (MD) in Clinical Pharmacology or equivalent, MD/PhD preferred.
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness, and financial security of our employees and their families. Benefits include group medical, vision, and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com.
Arvinas is an Equal Opportunity Employer.