Arvinas · 8 hours ago
Senior Medical Director, Clinical Development - Neuroscience
United States
Full-time
Remote
Senior Level
5+ years expArvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. They are seeking an experienced Senior Medical Director to lead the strategy, development, and execution of clinical research programs targeting neurodegenerative diseases.
BiotechnologyHealth CarePharmaceuticalTherapeutics
No H1B
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
Qualification
Required
A minimum of 5 years (7+ years strongly preferred) of biotech/pharma clinical development experience in 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
Experience supervising physicians and/or scientific staff in a management or team leader capacity 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
M.D. or equivalent degree is required
Formal training in the areas of Neurology is required
Benefits
Group medical, vision and dental coverage
Group and supplemental life insurance
And much more
Company
Arvinas
Arvinas advances therapies degrading disease-causing proteins for life-threatening diseases, from discovery to commercialization.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$461.6MKey Investors
Logos CapitalNextech Invest
2025-08-15Post Ipo Equity
2023-11-27Post Ipo Equity· $350M
2018-09-26IPO
Leadership Team
Angela M. Cacace
Chief Scientific Officer
Craig M. Crews
Founder
Recent News
Canaan Partners
2025-12-03
2025-11-11
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