Senior Medical Director

The role

The Senior Medical Director is responsible for medical affairs and clinical development, including medical oversight of clinical studies. This person will work across various phases of clinical development and provide medical input to achieve operational excellence.

What you will do

• Develop overall product strategy in multiple indications working cross functionally.
• Work with Clinical Operations, Biometrics, and Pharmacovigilance to complete clinical development programs.
• Lead teams to execute clinical development goals including trial execution and medical affairs planning.
• Contribute to communication strategy via publications, manuscripts, abstracts, posters and scientific presentations.
• Make contributions on 2 or more pivotal programs in clinical development program.
• Direct human clinical trials, phases 1-3, for lead candidate in development.
• Participate in medical review of adverse event reports and monitoring of incoming safety data.
• Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and other agencies.
• Present to external stakeholders including regulators, principal investigators, and scientific conference attendees.
• Provide input on the design of clinical studies supporting clinical strategy.

Required qualifications

• Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development
• A 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/o
• Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA
• Fluent in English and at least one or more other European languages (French, Spanish, German, Italian, etc.)
• Proficient user of standard MS Office suite (e.g., Word, Excel)
• Strong computer and database skills
• Attention to detail, accuracy and confidentiality
• Clear and concise oral and written communication skills
• Excellent organizational skills
• Critical thinking, problem solving, ability to work independently
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
• Communicate effectively and articulate complex ideas in an easily understandable way

Nice to have

• Prior experience in a mid-sized, fast-growing pharmaceutical environment
• experience using electronic document management systems, and document review tools

Benefits

• bonus
• stock
• benefits

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.