Arvinas - Senior Medical Director Clinical Development Neuroscience
Requirements
• 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 in-licensing or internal development. • Experience supervising physicians and/or scientific staff in a management or team leader capacity is highly desirable. • 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 home office environment. Employees must be able, with or without 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 • M.D. or equivalent degree is required. • Formal training in Neurology and professional board certification are highly preferred.
Responsibilities
• 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. • 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.
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