Cedent Consulting
Medical Director, Immuno-Oncology Clinical Development Lead (Waltham, MA)
Cedent Consulting, Watertown, Massachusetts, us, 02472
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 programs 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 programincluding 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 drugs 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 III) 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.
#J-18808-Ljbffr
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 programs 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 programincluding 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 drugs 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 III) 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.
#J-18808-Ljbffr