Medical Director, Immuno-Oncology Clinical Development Lead

Medical Director For Immunotherapy Clinical TrialsAs 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 ResponsibilitiesClinical Development & Medical OversightSynthesize 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 milestonesDesign a dose-escalation and dose expansion or backfill Phase 1 trial, using decision-tree models to enable protocol adaptabilityWork closely with clinical research and operations teams to execute studiesServe as Medical Monitor, providing continuous safety oversight throughout the trial lifecycle, reviewing AEs and SAEs, assessing causality, and informing patient-level medical decisions as neededLead and coordinate Safety Review Committee (SRC) meetings and synthesize expert inputs to guide decisions on study modifications as neededIND-Enabling LeadershipAuthor 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 documentsCross-Functional CollaborationDrive cross-functional planning and decision-making, proactively managing risks against the clinical development plan and study milestonesRepresent Client in interactions with study sites, regulatory agencies, advisory board meetings, and safety review committeePresent clinical program progress and strategic direction to internal or external stakeholdersQualifications and ExperienceMD required; U.S. medical accreditation strongly preferredPhD preferred but not requiredAt least 5-6 years of clinical experience leading early-phase (Phase III) immuno-oncology trials in biotech or pharmaceutical settingsMust have immuno-oncology expertise, with a strong preference for biologics-based immunotherapyProven ability to synthesize translational and preclinical data into actionable, adaptive clinical development strategies and FIH protocols; writing samples will be requestedDemonstrated leadership in cross-functional team collaboration to drive executionStrategic thinker with an entrepreneurial mindset and a clear understanding of how to transition FIH trials into later-stage clinical developmentWillingness and ability to travel