Medical Director Role Overview

Overview Of Role

We are seeking a physician to serve as a Medical Director to oversee global Phase 3 clinical trials and BLA (Biologic Licensing Application) filings. The incumbent will be primarily responsible for developing and executing an integrated clinical trial program including protocol design and medical oversight of new or ongoing studies. They will be responsible for obtaining scientific advisory input, working with biostatisticians for phase 3 design and analyses, supporting regulatory interactions for product advancement, and working 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. 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 or multiple potentially pivotal programs.

Role And Responsibilities

• Significant Oncology Experience: The role will require expertise in the treatment and management of oncology diseases 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.
• Make vital contributions on pivotal programs in clinical development programs.
• Direct human clinical trials, phases 1-3, for lead candidates in development, helping to ensure all clinical development milestones are met including enrollment goals.
• Participate 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, principal 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.
• 3+ 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.

Compensation

The pay range for this role is $240,000-$270,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits, and/or other applicable variable compensation.

Referral Policy

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.