Director, CMC 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 three clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766, which are being developed as potential treatments 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 350 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.

Position Summary

This role is responsible for defining regulatory CMC strategy, planning and the preparation of global CMC regulatory submissions to achieve timely approvals with a focus on development programs. Responsibilities include actively leading the development and implementation of CMC regulatory strategy for specific small molecule, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on the cross functional sub teams for the assigned program.  In addition, this role will input directly to the writing of regulatory documents, as necessary.

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

This position reports to the Executive Director, Regulatory CMC and can be remote, hybrid, or located at our headquarters in New Haven, CT.

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 regulatory CMC submissions and responses to Health Authority questions.
• Ensures that the global regulatory CMC strategy for assigned products are consistent with the teams and business goals, missions and objectives and meet Health Authority requirements.
• Accountable for review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.
• Leads cross-functional teams responsible for the preparation of CMC regulatory submissions and responses for assigned projects/products.
• Ensures effective communication of CMC regulatory strategy, risks, and overall plans to leadership and teams.
• Highlights and proactively communicates anticipated and ongoing critical Regulatory CMC issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.
• Accountable for all regulatory CMC related interactions, resolution of CMC issues and negotiation of CMC approvals.
• The incumbent is expected to be an active participant in drug substance and drug product technical team meetings.
• 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 assigned projects/products.
• Partners with regulatory operations and leads for exchange of project/product related information and submission planning.
• Accountable for the coordination and overall global approval of regulatory assessments for CMC changes.
• Facilitates and communicates CMC lessons learned from various submissions or activities to improve understanding of requirements and build efficiencies.
• Monitors and influences changes in the global Regulatory CMC environment in alignment with business needs.
• Responsible for management, coaching and development of direct reports as applicable.

Qualifications

• At least 10+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 7+ years of experience in Regulatory CMC.
• Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND), and/or chemical entities.
• Broad background of CMC development and registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more regions (US and EU preferred).
• Extensive experience in direct communication and negotiation with regulatory agencies on CMC topics
• Knowledge of FDA/EU and ICH CMC-related 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 CMC 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.

 Education

• BS University degree in Chemistry, Engineering, Biotechnology, or relevant discipline

#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