Medical Director / Senior Medical Director, Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Acts as the medical monitor for clinical trials, aiding in the resolution of significant issues impacting assigned studies.

• Collaborates with the Clinical Scientist, Data Manager, Pharmacovigilance Scientist, and other team members to execute clinical studies, encompassing study design, operational feasibility evaluations, and site selection.

• Offers expert opinions and reviews for the development of essential study documents, such as clinical study protocols, safety and medical monitoring plans, charters, and informed consent forms.

• Engages closely with Regulatory Affairs to contribute to or review clinically relevant sections of investigator brochures, briefing books, and other regulatory documents and communications.

• Facilitates investigator meetings, leads site initiation visits, and cultivates relationships with clinical trial investigators.

• Collaborates cross-functionally with internal discovery and translational scientists, technical operations/manufacturing teams, regulatory affairs, safety and pharmacovigilance, and external consultants or CROs.

• Oversees and assists in the collection, analysis, review, interpretation, and reporting of clinical safety and efficacy data.

• Supports the publication and external communication strategy by taking ownership of clinical data, collaborating on the development of meeting abstracts, presentations, and publications, and presenting at investigator meetings and scientific conferences as necessary.

⛳️ Requirements

• MD, DO, or equivalent medical degree with experience in patient care at the graduate medical level and beyond. Board certification or significant clinical experience in hematology, medical oncology, or hematology-oncology is required.

• Minimum of 3-5 years of experience in clinical investigation within a pharmaceutical or biotechnology setting, or equivalent academic clinical trial leadership experience. The Senior Medical Director role generally demands broader independent program leadership experience.

• Proficiency in oncology drug development, clinical trial design, medical monitoring, and the analysis of safety and efficacy data.

• Familiarity with Good Clinical Practice, clinical trial execution, and regulatory expectations for oncology development.

• Proven ability to make independent, timely, and appropriate decisions in a dynamic biotechnology environment.

• Exceptional interpersonal, verbal, and written communication skills, with the capability to effectively collaborate with cross-functional teams and external stakeholders.

• Direct experience in AML, myeloid malignancies, or leukemia drug development is strongly preferred.

• Experience with T-cell engagers, bispecific antibodies, cellular therapies, or other immune effector therapies, including CRS/ICANS risk management, is strongly preferred.

🏝️ Benefits

• Annual bonus opportunity (25% of salary)

• Annual equity awards

• Medical, dental, vision, life, and disability insurance

• 401(K) plan with employer match

• Stock options

• Employee stock purchase plan

• Flexible non-accrual paid time off

• Paid holidays

• End-of-year shut down

• Cell phone reimbursement

• Tuition reimbursement

• Paid parental leave