Job Title: Medical Director – Clinical Development (Oncology)
Location: Raleigh-Durham, North Carolina (Hybrid)
Employment Type: Full-Time, Permanent
Industry: Pharmaceutical / Biotech – Oncology
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.
This is a hybrid role, with 2-3 days per week expected onsite in the Raleigh-Durham area.
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.
Compensation & Benefits
- Competitive base salary.
- Annual performance bonus and long-term equity incentives.
- Comprehensive health, dental, vision, and retirement benefits.
- Generous PTO and flexible hybrid working mode
Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.
