Senior Medical Director

Overview of Role: 

We are seeking a physician to serve as a Senior Medical Director to oversee global Phase 3 clinical trials a BLA (Biologic Licensing Application) filings. The incumbent will be primarily responsible for developing and executing an integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies.  They will be responsible for obtaining scientific advisory input, work with biostatisticians for phase 3 design and analyses, support regulatory interactions for product advancement, and work closely with clinical operations to provide advice and decision making regarding medical input to achieve operational excellence.   

The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key medical expert for multiple cross functional teams.  This position will provide medical insight across a myriad of functions from discovery to manufacturing are expected.  Additionally, the Medical Director will play a pivotal role in leading investigator engagements including travel to support face-to-face interaction and protocol training.  Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred, as this role will be working on product development in an extremely fast-paced and intense environment.   The Medical Director will serve as a leader on one multiple potentially pivotal programs.  

Role and Responsibilities: 

• Significant Oncology Experience the role will require expertise in the treatment and management of oncology disease such that knowledge can be applied to the strategy and clinical development of Summit medicines to benefit patients 
• Work cross functionally with Medical Affairs, Regulatory, Commercial and other functions to develop the overall product strategy in multiple indications 
• Work cross functionally with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to successfully complete clinical development programs leading to BLA approvals 
• Lead teams to execute on clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning) 
• Manage direct reports or cross functional team members as needed based on team needs 
• Contribute to the communication strategy of Summit products via publications, manuscripts, abstracts, posters and scientific presentations 
• Making vital contributions on pivotal programs in clinical development program  
• Directing human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals 
• Participating in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals  
• Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and  government, regulatory, or partner agencies   
• Presentations to various external stakeholders - regulators, governing and harmonization bodies, principle investigators, scientific conference attendees, advisors and opinion leaders  
• Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review  
• Planning, reviewing and editing Clinical Study Reports  
• Planning, reviewing and editing publications from the program 
• Providing input on the design of clinical studies supporting clinical strategy  
• All other duties as assigned 

Experience, Education and Specialized Knowledge and Skills: 

• Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development  
• Minimum of 5+ years’ experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of hematology/oncology 
• Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA  
• Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission