Medical Director - Hematology
About The Position
The Medical Director provides medical oversight for assigned clinical trials and serves as the primary medical resource for investigators and study teams. This individual is responsible for ensuring participant safety, supporting protocol execution, reviewing clinical data, and contributing to high-quality study conduct in accordance with GCP, regulatory requirements, and company objectives. Working collaboratively across Clinical Development, Clinical Operations, Safety, Biometrics, Regulatory Affairs, and external partners, the Medical Director helps ensure studies are conducted efficiently while maintaining scientific integrity and patient safety.
Requirements
- MD required.
- Board certification or board eligibility in hematology / oncology.
- 5+ years of clinical experience and/or pharmaceutical or biotechnology industry experience.
- Experience serving as a Medical Monitor or Medical Director for interventional clinical trials.
- Strong understanding of ICH-GCP, FDA regulations, and clinical trial conduct.
- Experience reviewing safety data and making medical decisions during clinical trials.
- Ability to interpret clinical data and identify emerging safety signals.
- Excellent communication and interpersonal skills.
- Comfortable working in a fast-paced biotech environment with significant cross-functional collaboration.
- Strong organizational skills and attention to detail.
Nice To Haves
- Experience supporting Phase 1 clinical studies in hematology / oncology preferred.
- Collaborative team player who enjoys working across functions.
- Able to balance strategic thinking with hands-on execution.
- Comfortable working with external CROs and investigators.
- Demonstrates sound medical judgment and a patient-focused mindset.
- Thrives in a dynamic, evolving biotech environment.
- Operate with a high degree of independence while partnering closely with cross-functional teams.
- Contribute to clinical development strategy beyond day-to-day study oversight.
- Support due diligence, investigator engagement, and program planning as needed.
- Willingness to take on responsibilities that evolve with the company's pipeline and stage of development.
Responsibilities
- Serve as the medical monitor for one or more clinical studies.
- Review safety data and emerging clinical information throughout study conduct.
- Provide timely medical guidance to investigative sites and CRO partners.
- Participate in eligibility reviews, protocol deviation assessments, and subject management discussions.
- Review serious adverse events (SAEs), adverse events of special interest (AESIs), and other safety information in collaboration with Pharmacovigilance.
- Support medical decision-making regarding dose modifications, discontinuations, and subject management.
- Partner with Clinical Operations to support successful study execution.
- Participate in investigator meetings, site training, and study initiation activities.
- Contribute to protocol development, informed consent documents, and study-related medical materials.
- Review clinical data for consistency, trends, and subject safety.
- Participate in data review meetings and support database lock activities.
- Work closely with Clinical Operations, Biometrics, Medical Writing, Regulatory Affairs, and Pharmacovigilance.
- Provide medical input for regulatory submissions and responses to health authorities.
- Support, safety review meetings as needed.
- Contribute to preparation of clinical study reports and publications.
- Develop productive relationships with investigators and key opinion leaders.
- Serve as a medical representative for assigned studies during internal and external meetings.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
