Senior Medical Director Clinical Development Neuroscience

Senior Medical Director

Arvinas is looking for an experienced Senior Medical Director with the passion and creativity to develop great medicines for neuromuscular and neurodegenerative diseases. The ideal candidate is a physician with experience in global drug development and filing, who is enthusiastic about applying their knowledge to improve the lives of patients with neurological diseases. This individual has excellent management and leadership capabilities and is motivated to participate in and lead an innovative drug development team.

Reporting to the Executive Medical Director of Clinical Research, Neuroscience, the Senior Medical Director will be primarily responsible for the development, oversight, and execution of clinical research and development programs, including pivotal trials and filing activities. This position will serve as a key liaison between company and clinical investigators and establish credible relationships with opinion leaders, regulatory officials and other key stakeholders and partners.

The successful candidate will be ready for a career defining experience and have the passion to drive several therapeutics for serious debilitating diseases to final approval.

This role can be located at our headquarters in New Haven, CT or work with a hybrid or remote work arrangement from a location within the U.S.

Principal Responsibilities

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

• Partner with discovery and biology leadership and provide clinical input and guidance to develop the neuroscience corporate strategy.
• Design Phase I/II/III research trials targeting neurologic diseases, requiring expertise and stewardship in the areas of CNS/Neurology
• Monitor the safety of patients enrolled in clinical studies
• 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.
• 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, develop, and maintain relationships with external experts to better understand the candidate drug's effects and gain strategic insights to strengthen the program.
• Provide clinical assessments of potential in-licensing assets, identifying novel therapeutics opportunities as well as critical study design and execution challenges.
• Lead the interpretation and summary of clinical trial data, including the preparation of study reports, integrated summaries, and clinical portions of package inserts and other product labeling.
• Provide input on and review of various reports, applications, and publications
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.

Additional Responsibilities, including but not limited to:

• Participate in the selection of clinical investigators
• Provide guidance to study investigators
• Provide medical support to Clinical Operations in the oversight of contract research organizations
• Provide medical and scientific input on clinical data, patient medical safety data, and laboratory values, maintaining an ongoing assessment of the safety profile, and efficacy data, as appropriate.
• Contribute to the overall strategy for drug development
• Collaborate on the preparation and submission of IND, CTA, and NDA documents, and safety reports.
• Support the clinical aspects of interactions with regulatory agencies worldwide
• Participate in the planning, writing, and review of Clinical Study Reports, regulatory updates, and submissions.
• Analyze and interpret study data for abstracts or publication as required.
• Assist in the evaluation of scientific opportunities by contributing to due diligence activities, including critical assessment of clinical and translational data.
• Provide medical expertise to support corporate partnering and business development efforts, including active participation in partnership committees and cross-functional task groups.
• Collaborate with senior leadership and cross-functional teams to inform overall company strategy and contribute to the identification, evaluation, 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.
• Ensure that medical activities in clinical trials are conducted in compliance with Good Clinical Practice standards.

Qualifications

• A minimum of 5 years (7+ years strongly preferred) of biotech/pharma experience in neurological disease clinical drug development
• Experience across multiple stages of clinical development, from IND to NDA / BLA.
• Global clinical development experience is required, and global filing experience is preferred.
• Technical (Medical and Scientific) experience evaluating targets/agents for…