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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, where you will help to define and oversee all clinical aspects of the program – including protocol design, tumor indication prioritization, dose selection and dose escalation, drug administration, patient eligibility/enrollment, medical monitoring, and regulatory engagement.
This role is ideally suited for someone with direct hands-on leadership experience in early-phase clinical trials within pharmaceutical or biotechnology companies. The ideal candidate will have deep clinical insights on immunotherapies and must be able to thrive in dynamic, early-stage biotech settings where resourcefulness, scientific rigor, and a proactive approach are critical to driving novel therapies forward.
KEY RESPONSIBILITIES
Clinical Development & Medical Oversight
• Synthesize data from non-clinical and translational studies and translate it into a cohesive clinical study plan that is aligned with the drug’s MoA and expected study milestones
• Design a dose-escalation and dose expansion or backfill Phase 1 trial, using decision-tree models to enable protocol adaptability
• Work closely with clinical research and operations teams to execute studies
• Serve as Medical Monitor, providing continuous safety oversight throughout the trial lifecycle, reviewing AEs and SAEs, assessing causality, and informing patient-level medical decisions as needed
• Lead and coordinate Safety Review Committee (SRC) meetings and synthesize expert inputs to guide decisions on study modifications as needed
IND-Enabling Leadership
• Author and/or review key regulatory documents, including the study synopsis, protocol, investigator brochure, ICF medical monitoring plan, safety narratives, CSRs, briefing books, and IND dossier documents
Cross-Functional Collaboration
• Drive cross-functional planning and decision-making, proactively managing risks against the clinical development plan and study milestones
• Represent Client in interactions with study sites, regulatory agencies, advisory board meetings, and safety review committee
• Present clinical program progress and strategic direction to internal or external stakeholders
QUALIFICATIONS AND EXPERIENCE
• MD required; U.S. medical accreditation strongly preferred
• PhD preferred but not required
• At least 5-6 years of clinical experience leading early-phase (Phase I–II) immuno-oncology trials in biotech or pharmaceutical settings
• Must have immuno-oncology expertise, with a strong preference for biologics-based immunotherapy
• Proven ability to synthesize translational and preclinical data into actionable, adaptive clinical development strategies and FIH protocols; writing samples will be requested
• Demonstrated leadership in cross-functional team collaboration to drive execution
• Strategic thinker with an entrepreneurial mindset and a clear understanding of how to transition FIH trials into later-stage clinical development
• Willingness and ability to travel
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, where you will help to define and oversee all clinical aspects of the program – including protocol design, tumor indication prioritization, dose selection and dose escalation, drug administration, patient eligibility/enrollment, medical monitoring, and regulatory engagement.
This role is ideally suited for someone with direct hands-on leadership experience in early-phase clinical trials within pharmaceutical or biotechnology companies. The ideal candidate will have deep clinical insights on immunotherapies and must be able to thrive in dynamic, early-stage biotech settings where resourcefulness, scientific rigor, and a proactive approach are critical to driving novel therapies forward.
KEY RESPONSIBILITIES
Clinical Development & Medical Oversight
• Synthesize data from non-clinical and translational studies and translate it into a cohesive clinical study plan that is aligned with the drug’s MoA and expected study milestones
• Design a dose-escalation and dose expansion or backfill Phase 1 trial, using decision-tree models to enable protocol adaptability
• Work closely with clinical research and operations teams to execute studies
• Serve as Medical Monitor, providing continuous safety oversight throughout the trial lifecycle, reviewing AEs and SAEs, assessing causality, and informing patient-level medical decisions as needed
• Lead and coordinate Safety Review Committee (SRC) meetings and synthesize expert inputs to guide decisions on study modifications as needed
IND-Enabling Leadership
• Author and/or review key regulatory documents, including the study synopsis, protocol, investigator brochure, ICF medical monitoring plan, safety narratives, CSRs, briefing books, and IND dossier documents
Cross-Functional Collaboration
• Drive cross-functional planning and decision-making, proactively managing risks against the clinical development plan and study milestones
• Represent Client in interactions with study sites, regulatory agencies, advisory board meetings, and safety review committee
• Present clinical program progress and strategic direction to internal or external stakeholders
QUALIFICATIONS AND EXPERIENCE
• MD required; U.S. medical accreditation strongly preferred
• PhD preferred but not required
• At least 5-6 years of clinical experience leading early-phase (Phase I–II) immuno-oncology trials in biotech or pharmaceutical settings
• Must have immuno-oncology expertise, with a strong preference for biologics-based immunotherapy
• Proven ability to synthesize translational and preclinical data into actionable, adaptive clinical development strategies and FIH protocols; writing samples will be requested
• Demonstrated leadership in cross-functional team collaboration to drive execution
• Strategic thinker with an entrepreneurial mindset and a clear understanding of how to transition FIH trials into later-stage clinical development
• Willingness and ability to travel
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