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