Medical Director

Overview Job Title: Medical Director – Clinical Development (Oncology) Employment Type: Full-Time, Permanent Industry: Pharmaceutical / Biotech – Oncology Location: Hybrid role with 2–3 days onsite per week in the Raleigh-Durham area. About the Company Our client is an innovative biopharmaceutical company committed to developing breakthrough oncology therapies that address unmet patient needs. With a strong clinical pipeline and a collaborative research culture, they are expanding their Clinical Development team to support ongoing and upcoming oncology trials. Position Overview As a Medical Director – Clinical Development (Oncology) , you will provide medical and scientific leadership for clinical programs across early- and late-phase oncology trials. You’ll play a key role in study design, execution, medical monitoring, data interpretation, and regulatory interactions , working cross-functionally with clinical operations, biostatistics, pharmacovigilance, and regulatory affairs. Key Responsibilities Serve as medical lead for oncology clinical trials (Phase I–III), ensuring scientific and clinical integrity of study protocols and execution. Author and review clinical development plans, protocols, investigator brochures, and regulatory submissions (IND, NDA, BLA) . Provide medical monitoring for ongoing studies, including safety oversight, adverse event evaluation, and data review. Partner with clinical operations and project management to ensure timelines, quality, and compliance with GCP/ICH guidelines. Collaborate with biostatistics and data management on analysis plans and interpretation of clinical data. Contribute to regulatory strategy and participate in meetings with FDA and other health authorities. Support publication strategy and present clinical data at internal and external scientific meetings. Provide medical/scientific guidance to cross-functional project teams and external investigators. Qualifications MD, DO, or equivalent medical degree (oncology, hematology, or related specialty preferred). Minimum 3–5 years’ experience in clinical development within the pharmaceutical or biotech industry. Proven track record in oncology clinical trials (early- or late-stage). Strong understanding of GCP, ICH guidelines, and US regulatory environment . Excellent communication and leadership skills, with the ability to influence cross-functional teams. Board certification in Oncology, Hematology, or related discipline . Experience in regulatory interactions (FDA, EMA, etc.) . Experience in both early-phase and pivotal studies . Annual performance bonus and long-term equity incentives . Generous PTO and flexible hybrid working model . Job Details Seniority level: Director Employment type: Full-time Job function: Science Industries: Pharmaceutical Manufacturing and Biotechnology Research Benefits Annual performance bonus Long-term equity incentives Generous PTO and flexible hybrid working model #J-18808-Ljbffr