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