Medical Director, Immuno-Oncology Clinical Development Lead (Waltham, MA)

Medical Director, Immuno-Oncology Clinical Development Lead (Waltham, MA)

As Client expands its clinical portfolio, we are preparing to initiate clinical trials for our lead novel immunotherapy for solid tumors. We are seeking a Medical Director to lead the program’s clinical development strategy and execute a FIH study. You will have the opportunity to shape clinical strategy and execution from the ground up and serve as a key clinical voice across internal and external stakeholders.

This role reports directly to the Executive Vice President of R&D and works closely with other functional teams. You will be expected to serve as a strategic clinical, medical, and operational leader, overseeing all clinical aspects of the program—including protocol design, tumor indication prioritization, dose selection and escalation, drug administration, patient eligibility/enrollment, medical monitoring, and regulatory engagement.

This role is ideally suited for someone with hands-on leadership experience in early-phase clinical trials within pharmaceutical or biotechnology companies. The ideal candidate will have deep clinical insights into immunotherapies and must thrive in dynamic, early-stage biotech settings where resourcefulness, scientific rigor, and a proactive approach are critical to advancing novel therapies.

KEY RESPONSIBILITIES

Clinical Development & Medical Oversight

• Synthesize data from non-clinical and translational studies to develop a cohesive clinical study plan aligned with the drug’s MoA and study milestones.
• Design a dose-escalation and dose-expansion or backfill Phase 1 trial, utilizing decision-tree models for protocol adaptability.
• Collaborate with clinical research and operations teams to execute studies.
• Serve as Medical Monitor, providing safety oversight throughout the trial, reviewing adverse events, assessing causality, and guiding medical decisions.
• Lead Safety Review Committee meetings and synthesize expert input for study modifications.

IND-Enabling Leadership

• Author and review regulatory documents such as study protocols, investigator brochures, ICF plans, safety narratives, CSRs, briefing books, and IND dossiers.

Cross-Functional Collaboration

• Drive planning and decision-making across teams, managing risks against development plans and milestones.
• Represent Client in interactions with study sites, regulatory agencies, advisory boards, and safety committees.
• Present clinical progress and strategic plans to stakeholders.

QUALIFICATIONS AND EXPERIENCE

• MD required; U.S. medical accreditation preferred.
• PhD preferred but not required.
• 5-6 years of clinical experience leading early-phase (Phase I–II) immuno-oncology trials in biotech or pharma.
• Expertise in immuno-oncology, especially biologics-based therapies.
• Ability to synthesize translational and preclinical data into actionable strategies and protocols; writing samples may be requested.
• Proven leadership in cross-functional team collaboration.
• Strategic thinker with an entrepreneurial mindset, capable of transitioning FIH trials into later phases.
• Willingness and ability to travel.