Senior Medical Director

Company

Ivonescimab, known as SMT112, is a novel, potential first‑in‑class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD‑1 with the anti‑angiogenesis effects associated with blocking VEGF into a single molecule.

Location

Menlo Park, CA / Miami, FL / Princeton, NJ (onsite)

Job Title

Senior Medical Director – Clinical Development

Overview of Role

We are seeking a physician to serve as a Senior Medical Director to oversee global Phase 3 clinical trials and BLA filings. The incumbent will be primarily responsible for developing and executing integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies. They will obtain scientific advisory input, work with biostatisticians for phase 3 design and analyses, support regulatory interactions, and collaborate with clinical operations to provide medical advice and decision making 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 many functions from discovery to manufacturing. Additionally, the Medical Director will lead investigator engagements, including travel for face‑to‑face interaction and protocol training. Prior experience in a mid‑sized, fast‑growing pharmaceutical environment is preferred.

Responsibilities

• Significant oncology experience and expertise in the treatment and management of oncology diseases to inform strategy and development of Summit medicines.
• Work cross‑functionally with Medical Affairs, Regulatory, Commercial and other functions to develop 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 clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning).
• Manage direct reports or cross‑functional team members as needed.
• Contribute to communication strategy via publications, manuscripts, abstracts, posters and scientific presentations.
• Make vital contributions to pivotal programs in clinical development.
• Direct and oversee human clinical trials, phases 1‑3, for the lead candidate, ensuring enrollment and milestone objectives.
• Participate in medical review of adverse event reports and monitoring of safety data with pharmacovigilance, including evaluating and escalating safety signals.
• Coordinate and develop reports for submission to FDA, EMA, PMDA and other regulatory agencies.
• Present to external stakeholders—regulators, governing bodies, investigators, scientific conferences, advisors and opinion leaders.
• Apply knowledge of trial conduct to support operational needs for planning and executing trials, including protocol adherence, safety reviews, assay development, training and document review.
• Plan, review and edit Clinical Study Reports and publications from the program.
• Provide input on design of clinical studies supporting clinical strategy.
• Perform all other duties as assigned.

Experience, Education, and Specialized Knowledge

Salary

Pay range : $283,000 – $353,500 annually. Compensation may include bonus, stock, benefits and other variable components.

Summit does not accept referrals from employment agencies. Applicants may apply directly through the company site.

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