Executive Medical Director, Clinical Development

Summary

Join Arvinas, a clinical-stage biotechnology company, as an experienced Executive Medical Director to develop groundbreaking medicines for neuromuscular and neurodegenerative diseases. This physician role requires global drug development and filing experience, strong leadership skills, and a passion for improving patient lives. You will lead pivotal trials, collaborate with investigators and regulatory officials, and contribute to the company's neuroscience strategy. The position offers a career-defining opportunity to drive therapeutics to final approval and can be located at our headquarters in New Haven, CT, or remotely within the U.S. Arvinas offers a competitive compensation and benefits package.

Requirements

• A minimum of 5+ years (10+ years strongly preferred) of clinical and managerial experience in drug development, ideally within neurological disease therapeutic areas
• Experience across multiple stages of clinical development, from IND to NDA / BLA
• Global clinical development experience required, and global filing experience strongly preferred
• Technical (Medical and Scientific) experience evaluating targets/agents for in licensing or internal development
• Excellent interpersonal and public speaking skills are required for this high visibility position
• Demonstrated ability to work in a matrix environment with cross-functional teams
• Must be legally authorized to work in the US without the need for employer sponsorship now or at any time in the future
• M.D. or equivalent degree is required

Responsibilities

• Partner with discovery and biology leadership and provide clinical input and guidance to develop the neuroscience corporate strategy
• Responsible for trial design of Phase I/II/III research trials targeting neurologic diseases, requiring expertise and stewardship in the areas of CNS/Neurology
• Directly supervise and monitor trial conduct
• Work closely with all functions of the organization and external partners to manage trial execution and investigators’ engagement
• Collaborate in developing global regulatory plans and play a key role in regulatory meetings in partnership with regulatory affairs. Identify opportunities for external collaboration
• Follow important developments and relevant trends in the scientific literature and develop/maintain contacts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development of study and overall program
• Develop effective relationships with external providers
• Provide clinical assessments of potential in-licensing assets, identifying novel therapeutics opportunities as well as critical study design and execution challenges
• Review written materials and provide editorial comments for clinical study reports and manuscripts
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws
• Design and develop clinical study protocols and associated clinical study documents and monitor required documentation in compliance with clinical development plans, GCP, and good medical practice
• Participate in the selection of clinical investigators, providing guidance to investigators on a study
• Provide medical supervision for contract research organizations and protocol procedures
• Provide medical and scientific input in review of clinical data, patient medical safety data, and laboratory values; maintaining an ongoing assessment of the safety profile, and efficacy data as appropriate
• Provide medical surveillance on Serious Adverse Event (SAE) reporting, and follow-ups
• Direct and oversee the overall strategy for clinical drug product development and collaborating with Regulatory personnel in IND, CTA, and NDA submission activities as well as submission of IND safety reports
• Lead the clinical aspect of interactions with regulatory agencies worldwide
• Participate in the planning, writing, and review of Clinical Study Reports, regulatory updates, and submissions
• Assist with due diligence of new scientific developments
• Analyze and interpret study data for abstracts or publication as required
• Support corporate partnering efforts and business development activities by providing medical expertise and participating in partnership committees/task groups
• Collaborate on overall company strategy and in licensing of new programs
• Work with the financial group as needed to assist with the production of budgets and timelines for the clinical development team
• Plan and lead clinical focus groups to create clinical trial and protocol designs
• Ensure that operational activities are conducted in compliance with all pertinent regulatory or statutory requirements and in accordance with the scientific standards, ethical and professional values, management philosophy, and established priorities, policies, and practices of the Company
• Lead the medical writing for the preparation of summarization of clinical trial data, including the preparation of study reports, integrated summaries, and clinical portions of package inserts and other product labeling

Preferred Qualifications

• Experience supervising physicians and/or scientific staff in a management or team leader capacity highly desirable
• Formal training in the areas of Neurology is desired

Benefits

• Competitive package of base and incentive compensation
• Comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families
• Group medical, vision and dental coverage
• Group and supplemental life insurance
• Hybrid or remote work arrangement from a location within the U.S