Director / Senior Director, Global and US Regulatory Strategy
Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes two clinical-stage programs: ARV-110, which is being developed as a potential treatment for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 200 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 purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.
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 and US Regulatory Strategy will be accountable, in alignment with Arvinas corporate strategy, for designing and delivering innovative, compliant, and rigorous global and US regulatory plans for drug development through approval. This position will provide strategic guidance to the development team(s) and governance teams. The qualified incumbent will lead regulatory strategy on assigned 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 the FDA, external collaborators, scientific advisors, and consultative partners.
This position reports to our Global Regulatory Strategy Executive Director and will be located at our headquarters in New Haven, CT or may be remote.
Key responsibilities of this role include, but are not limited to:
- Develop and direct global and US regulatory strategies for priority projects and programs; design and provide expert guidance on clinical and pre-clinical regulatory requirements and strategies, including submission planning, labeling, advertising, and promotions. Support development of the late-stage clinical development plan.
- Identify, assess, and mitigate global and US regulatory risks associated with product development.
- Develop and maintain excellent rapport and relationships with FDA in the representation, influence, and negotiation around Arvinas’s strategic regulatory plans.
- Coordinate interactions with FDA; lead clinical and non-clinical FDA correspondence and regulatory applications (IND and NDA) to support clinical development activities.
- Represent the US/global regulatory strategy and function, and collaborate effectively at all levels internally and externally. These interactions include sharing expertise and demonstrating influence in strategic 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 government regulators.
- Guide the preparation of-/ or draft- all documentation related to Arvinas US regulatory submission packages, development of internal documentation practices, relevant SOPs.
- Oversee CRO’s regarding CTA submissions and study conduct outside the US.
- 10 + years pharmaceutical/biotechnology industry experience with functional/ technical management experience. Minimum of 7 years in Strategic Regulatory Affairs leadership. Supervisory experience of Regulatory Operations function a plus.
- Expert knowledge and demonstrated experience in driving global/US oncology programs through submission to approval is desirable.
- Expertise in the preparation of major US regulatory submissions, supportive amendments /supplements and responses to inquiries is required.
- Expert knowledge with regards to oncology regulatory landscapes in the US is required. Comprehensive knowledge of applicable regulations and experience in interpretation of US regulations, guidelines, policy statements, etc. is necessary.
- Demonstrable success in interacting with FDA.
- Demonstrate excellent leadership and communication skills.
- BS/MS or other degree relevant to life science discipline is required.
- Advanced degree a plus (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