Executive Medical Director, Clinical Development

Summary

Join Arvinas, a clinical-stage biotechnology company, as an Executive Medical Director to lead and contribute to the development of oncology therapeutics. This role involves strategic planning and execution of clinical research and development programs, from early to late phases, including pivotal trials and regulatory filings. You will collaborate with internal and external stakeholders, including clinical investigators, regulatory officials, and external partners. The position requires a physician with extensive experience in global drug development and strong leadership skills. The role can be based at our headquarters in New Haven, CT, or in a hybrid/remote arrangement within the U.S. This is a career-defining opportunity to drive innovative therapies for serious diseases to final approval.

Requirements

• Board certified MD or MD/PhD with a minimum of 5+ years (10+ years strongly preferred) of clinical and managerial experience in drug development, within oncology/hematology disease therapeutic areas
• Experience across multiple stages of clinical development, from IND to NDA / BLA
• Global clinical development experience required, and global filing experience 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
• The duties of this role are generally conducted in a combination of lab and home office environments. Employees must be able, with or without an accommodation to lift/carry 15/30 pounds unassisted/assisted; work comfortable in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving, analysis and dialogue; collaborate with others; maintain general availability during standard business hours
• MD. or equivalent degree is required

Responsibilities

• Partner with discovery and biology leadership and provide clinical input and guidance to develop the oncology corporate strategy
• Responsible for trial design of Phase I/II/III research trials requiring expertise and stewardship in the areas of oncology/hematology
• 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 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 the 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 is highly desirable
• Formal training in the areas of oncology/hematology is desired

Benefits

• Group medical, vision and dental coverage
• Group and supplemental life insurance
• Remote work