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 currently enrolling: vepdegestrant for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-102 for the treatment of patients with neurodegenerative disorders, and ARV-393 for the treatment of patients with relapsed/refractory non-Hodgkin Lymphoma and potentially other lymphomas.

In April 2024, Arvinas entered into a transaction with Novartis, including a global license agreement for the development and commercialization of the clinical stage PROTAC ® androgen receptor protein degrader ARV-766 for the treatment of prostate cancer. The transaction closed in May 2024.

#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 .

Position Summary

The Executive Director, Global Regulatory Strategy is responsible for designing and delivering innovative, compliant, and rigorous regulatory plans to achieve timely approvals for the Arvinas portfolio assigned to them. This position is responsible for leading the development of regulatory strategy on our highest priority cross-functional programs, through pre-clinical and clinical development, as well as through life-cycle management initiatives. This position also represents Arvinas with domestic and international regulatory authorities, external collaborators, scientific advisors, and consultative partners.

This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, regulatory knowledge, and interpersonal skills are required.

This position reports to the Senior Vice President of Regulatory Affairs and can work remotely from a location within the U.S.

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

• Accountable for strategy, planning, definition of content, preparation, review and approval of global and US regulatory strategies for assigned projects and programs; design and provide expert guidance on clinical and pre-clinical regulatory requirements and strategies, including submission planning, labeling, advertising, and promotions.

• Ensures that the global regulatory strategy for assigned products are consistent with the team’s and business goals, missions and objectives and meet Health Authority requirements.

• Ensures effective communication of regulatory strategy, risks, and overall plans to leadership and teams.

• Highlights and proactively communicates anticipated and ongoing critical Regulatory risks/issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.

• Leads cross-functional teams responsible for the preparation of regulatory submissions and responses for assigned projects/products.

• Accountable for review and approval of submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.

• Accountable for Health Authority interactions (non-CMC) for assigned projects, and for developing and maintaining excellent rapport and relationships with FDA 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 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.

• Responsible for the development of internal documentation practices, relevant SOPs and working to them.

• Oversee regulatory CRO’s or consultants who are supporting assigned projects , including but not limited to CTA submissions and study conduct outside the US.

• Lead cross-functional teams and operate within a matrix organizational structure.

• Author and review cogent and persuasive briefing documents, submission sections, and responses.

• Establishes and maintains modes of effective communication and collaboration with the teams of assigned projects/products.

• Partners with regulatory operations leads for exchange of project/product related information and submission planning.

• Monitors and influences changes in the global Regulatory environment in alignment with business needs.

• Responsible for management, coaching and development of direct reports as applicable.

Qualifications

• 15 + years pharmaceutical/biotechnology industry experience with functional/ technical management experience. Minimum of 10 years in Strategic Regulatory Affairs leadership.

• Successful leadership and expertise in delivering major regulatory submissions (including marketing authorizations and clinical trial applications), supportive amendments /supplements and responses to inquiries is required.

• Expert knowledge with regards to neuroscienceglobalregulatory landscapes is required.

• Broad background of drug development and registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more regions (US and EU preferred).

• Experience in direct communication and negotiation with regulatory agencies, particularly the FDA.

• Knowledge of relevant FDA/EU and ICH guidance and regulations

• Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.

• Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.

• Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.

• Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.

• Demonstrated ability to pioneer and execute on an agreed global regulatory strategy and ensure that results are in alignment with business priorities.

• Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.

• Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.

• Competence in people development and management.

• Experience in project management and/or a drug substance or drug product development role.

• Arvinas will not be providing VISA sponsorship for this position now or in the future. You must have the ability to work without a need for a current or future VISA sponsorship.

• The duties of this role are generally conducted in a home office environment. Employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Education

• BS/MS or other degree relevant to life science discipline is required.

• Advanced degree a plus (PharmD, MSc, PhD, MD, MBA).

#LI-Remote

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