What are the responsibilities and job description for the Medical Director, Immuno-Oncology Clinical Development Lead (Waltham, MA) position at CEDENT?
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
