Arvinas is a clinical-stage biotechnology 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 three investigational clinical-stage programs: ARV-766 and bavdegalutamide for the treatment of men with metastatic castration-resistant prostate cancer; and vepdegestrant (ARV-471) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. Arvinas, as part of its overall business strategy, selectively assesses opportunities for potential collaboration, license, marketing and royalty arrangements, and similar transactions, to advance and accelerate the development and enhance the commercial potential of its product candidates.
#TeamArvinas is made up of approximately 450 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and mission – to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC® protein degradation platform. We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. But don’t just take our word for it – learn more about life at Arvinas and what employees have to say.
For more information, please visit www.arvinas.com.
The Director, Clinical Pharmacology will serve on Arvinas drug development program teams. Leads subject matter experts including but not limited to, investigators, key opinion leaders in the external Clinical Pharmacology community and regulatory authorities. The individual will work closely with key stakeholders to develop clinical pharmacology strategy and design clinical pharmacology studies in support of our company’s mission to bring hope and new therapies for patients.
This position reports to the Senior Director, Clinical Pharmacology and can be located at our headquarters in New Haven, CT or work remotely from a location within the U.S.
- Serve as the lead clinical pharmacology representative on Arvinas drug development program teams.
- Collaborate with subject matter experts in Clinical Research, DMPK, Regulatory, CMC, Toxicology, Pharmacology to progress clinical compounds from preclinical through all phases of clinical development, in a program team
- Provide input into identifying appropriate clinical pharmacology investigators/CROs for these studies.
- Develop and implement clinical pharmacology strategy; design and execute clinical pharmacology plan, including clinical pharmacology studies, and be accountable for the analysis and interpretation of pharmacokinetic and pharmacodynamic
- Work closely with physicians, scientists, regulatory professionals, statisticians and members of the clinical operations department to carry out these responsibilities.
- Respond to inquiries by practitioners and investigators, IRBs, regulatory bodies, and vendors on Clinical Pharmacology related questions.
- Establish relationships with key Clinical Pharmacology opinion leaders, external Clinical Pharmacology advisors and collaborators
- Review clinical pharmacology and clinical research report and summary documents, using clinical pharmacology expertise to identify ways to best analyze and present pharmacokinetic and pharmacodynamic data in a complete, accurate and scientifically sound
- Publish, evaluate and assess clinical pharmacology publications (abstracts, posters, manuscripts).
- Responsible for clinical pharmacology- regulatory submissions including IND and/or NDAs.
- Establish work processes & procedures for the clinical pharmacology department.
- A minimum of 8+ years of clinical drug development experience in industrial, academic, or regulatory settings; successful in implementing clinical pharmacology studies with a minimum of 6 years of clinical pharmacology team leadership experience.
- Demonstrated track record of high impact publications and/or presentations at premier clinical pharmacology meetings; track record of successful delivery of clinical pharmacology-responsible regulatory submissions such as the IND or NDAs, and with other global regulatory agencies such as EMA, PMDA or TGA.
- People management experience and/ or experience with mentoring.
- Experience in at least one of the following therapeutic areas: medical oncology, hematology, immunology, and/or CNS.
- 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 record of applying advanced pharmacokinetic and pharmacodynamic modeling software such as NLME, NONMEM, Gastroplus or Simcyp to support program decision is highly desirable.
- Hands-on experience with data cleaning and data transformation with programming or software programs (e.g. R, spotfire) would be
- Bioanalytical exposure would be a plus.
- Doctor of Pharmacy (PharmD), Doctor of Pharmaceutical Sciences (PhD), Doctor of Medicine degree (MD) in Clinical Pharmacology or equivalent, MD/PhD pre
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