Open Positions: Director/ Senior Director, Global Regulatory Strategy
Arvinas is a clinical-stage biopharmaceutical company focused on developing new small molecules ‒ known as PROTAC® (PROteolysis Targeting Chimera) protein degraders ‒ aimed at degrading disease-causing cellular proteins via proteolysis. Based on innovative research conducted at Yale University by Dr. Craig Crews, Founder and Chief Scientific Advisor, the company is translating natural protein degradation approaches into novel drugs for the treatment of cancer and other diseases. Our proprietary PROTAC®-based drug paradigm induces protein degradation, rather than protein inhibition, using the ubiquitin proteasome system and offers the advantage of potentially targeting “undruggable” as well as “druggable” elements of the proteome. This greatly expands the ability to create drugs for many new, previously unapproachable targets.
This exciting new position is joining our organization as we grow and progress an increasingly robust and diverse portfolio at Arvinas! The Director/ Senior Director, Global Regulatory Strategy will be accountable, in alignment with Arvinas corporate strategy, for designing and delivering innovative, compliant, and rigorous regulatory plans for drug development through approval both within- and external- to the U.S. This position will provide strategic guidance to internal executive and governance teams. The qualified incumbent will lead regulatory strategy on our highest priority cross-functional drug development programs, through pre-clinical and clinical development, as well as through life-cycle management initiatives. This leader will represent Arvinas with domestic and international regulatory authorities, external collaborators, scientific advisors, and consultative partners.
This position reports to our Chief Medical Officer and will be located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- Direct global regulatory strategies for priority projects and programs; design and provide expert guidance on development and implementation of global clinical and pre-clinical regulatory strategies, including submission planning, labeling, advertising, and promotions. Support development of the late-stage clinical development plan. Direct regulatory activities related to global life cycle management of products.
- Identify, assess, and mitigate regulatory risks associated with product development.
- Develop and maintain excellent rapport and relationships with relevant regulatory agencies in the representation, influence, and negotiation around Arvinas’s strategic regulatory plans.
- Represent the Regulatory strategy and function, and collaborate effectively at all levels internally and externally. These interactions include sharing expertise and demonstrating influence in executive strategy discussions, on cross-functional project teams, governance committees and external meetings with collaborators/ partners/ KOLs, expert consultants, contracted resources, clinical partners, manufacturers, etc. Foster positive relationships with domestic and global government regulators.
- Guide the preparation of-/ or draft- all documentation related to Arvinas regulatory submission packages, development of internal documentation practices, relevant SOPs.
- Educate, support, coach, mentor, motivate, and grow regulatory professionals who are developing expertise across various drug development phases or therapeutic areas, in either a supervisory or matrix leadership capacity.
- 10 + years pharmaceutical/biotechnology industry experience with functional/ technical management experience. Minimum of 5 years in Strategic Regulatory Affairs leadership. Supervisory experience of Regulatory Operations function a plus.
- Expert knowledge and demonstrated experience in driving oncology programs through submission to approval is required. Experience and strong knowledge in neuroscience drug development is highly desirable.
- Expertise in the preparation of major regulatory submissions, supportive amendments /supplements and responses to inquiries is required.
- Expert knowledge with regard to oncology regulatory landscapes in the US, EU, Japan is required—knowledge of ROW is helpful. Comprehensive knowledge of applicable regulations and experience in interpretation of regulations, guidelines, policy statements, etc. is necessary.
- Demonstrable success in interacting with relevant regulatory authorities (FDA, EMA, and PMDA).
- Demonstrate excellent leadership and communication skills.
- BS/ MS or other degree relevant to life science discipline is required. Advanced degree preferred (PharmD, MSc, PhD, MD, MBA).
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.