Senior Medical Director, Clinical Development & Safety, Oncology-632163

Our client is seeking an experienced physician to provide medical leadership across its early-stage oncology clinical development programs. Reporting directly to the Chief Medical Officer, this individual will oversee medical monitoring and clinical safety for Phase 1/2 oncology studies while contributing to broader clinical development strategy.
This is a highly visible, hands-on role for a physician with sponsor-side experience supporting Phase 1 oncology dose-escalation studies. The successful candidate will work closely with Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biometrics, Translational Medicine, and external partners to support the safe and effective advancement of Repertoire’s oncology pipeline.
Key Responsibilities
Medical Monitoring and Study Leadership
Serve as Medical Monitor for Phase 1/2 oncology clinical trials.
Provide medical guidance to investigators, clinical sites, and internal study teams.
Review and adjudicate subject eligibility questions and protocol-related medical issues.
Monitor patient-level clinical and safety data throughout study conduct.
Evaluate and guide the management of immune-related toxicities, including CRS and ICANS.
Apply ASTCT grading criteria and other relevant clinical guidelines.
Support protocol development, amendments, eligibility criteria, toxicity-management guidance, and medical-monitoring plans.
Dose Escalation and Safety Review
Provide medical leadership for dose-escalation and dose-expansion activities.
Evaluate potential dose-limiting toxicities and contribute to DLT adjudication.
Prepare for, present at, and support Safety Review Committee and dose-escalation meetings.
Integrate emerging safety, clinical, PK/PD, and biomarker data to inform dose-escalation and development decisions.
Partner with the CMO and cross-functional stakeholders on dose selection, safety stopping rules, and expansion-cohort decisions.
Clinical Safety and Pharmacovigilance
Provide medical review and causality assessment of serious adverse events.
Determine seriousness, expectedness, relatedness, and whether events meet SUSAR or expedited-reporting requirements.
Assess expectedness against the Investigator’s Brochure reference safety information.
Lead ongoing aggregate safety review, signal assessment, and benefit-risk evaluation.
Provide medical leadership for DSURs, Investigator’s Brochure safety updates, and RSI revisions.
Provide medical oversight of external pharmacovigilance vendors and ensure high-quality execution of outsourced safety activities.
Support IND safety reporting and global clinical-trial safety requirements, including EU CTR.
Clinical Development Strategy
Contribute to clinical development plans for current and future oncology programs.
Provide medical input into study design, dose and schedule selection, expansion cohorts, and future development opportunities.
Interpret emerging clinical, safety, pharmacologic, and translational data in the context of the overall development strategy.
Support clinical and safety components of regulatory submissions, briefing documents, and health-authority interactions.
Partner with cross-functional leadership to advance programs from first-in-human development through proof of concept.
Qualifications
Required
MD or equivalent medical degree.
5+ years of biotechnology or pharmaceutical industry experience in clinical development.
Hands-on sponsor-side medical-monitoring experience for Phase 1 oncology dose-escalation studies.
Experience making subject-eligibility decisions and responding to investigator and study-team medical questions.
Direct experience with DLT adjudication and dose-escalation or Safety Review Committee meetings.
Knowledge of CRS and ICANS assessment and management, including ASTCT grading.
Experience evaluating SAEs, causality, expectedness, SUSARs, and IND safety-reporting requirements.
Familiarity with DSURs, Investigator’s Brochures, RSI updates, aggregate safety review, and signal assessment.
Ability to operate as a hands-on physician leader within a fast-moving, resource-conscious biotechnology environment.
Preferred
Medical oncology or hematology training.
Experience with T-cell engagers, TCR bispecifics, bispecific antibodies, cell therapy, or other immuno-oncology modalities.
Experience with first-in-human oncology programs involving CRS, ICANS, or other immune-mediated toxicities.
Working knowledge of EU CTR and global clinical-trial safety requirements.
Experience overseeing CROs, pharmacovigilance vendors, and external medical monitors.
Small or mid-sized biotechnology experience.
Experience contributing to broader clinical development strategy, including dose optimization, expansion cohorts, and proof-of-concept planning.