Medical Director, Clinical Development - Oncology

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 Join an innovative biopharmaceutical company dedicated to creating groundbreaking oncology therapies that meet significant patient needs. With a robust clinical pipeline and a collaborative research culture, we are expanding our Clinical Development team to enhance ongoing and upcoming oncology trials. Position Overview As the Medical Director Clinical Development (Oncology), you will be the cornerstone of medical and scientific leadership for clinical programs across both early- and late-phase oncology trials. This is a unique opportunity to influence study design, execution, medical monitoring, data interpretation, and regulatory interactions while collaborating across various departments including clinical operations, biostatistics, pharmacovigilance, and regulatory affairs. Key Responsibilities Act as the medical lead for oncology clinical trials (Phase I-IV), ensuring the scientific and clinical integrity of study protocols and their execution. Author and review key documents such as 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. Collaborate with clinical operations and project management to meet timelines, uphold quality, and ensure compliance with GCP/ICH guidelines. Work with biostatistics and data management on analysis plans and clinical data interpretation. Contribute to regulatory strategy and engage in meetings with FDA and other health authorities. Support publication strategy and represent clinical data at both internal and external scientific meetings. Offer medical and scientific guidance to cross-functional project teams and external investigators. Qualifications MD, DO, or equivalent medical degree (oncology, hematology, or related specialty preferred). A minimum of 3-5 years of experience in clinical development within the pharmaceutical or biotech industry. Proven track record in conducting oncology clinical trials (early or late-stage). Strong knowledge of GCP, ICH guidelines, and the US regulatory landscape. Excellent communication and leadership abilities, with the capability to influence cross-functional teams effectively. Board certification in Oncology, Hematology, or a pertinent discipline. Experience with regulatory interactions (FDA, EMA, etc.). Experience spanning both early-phase and pivotal studies. Annual performance bonus and long-term equity incentives. Generous PTO along with a 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 along with a flexible hybrid working model