Medical Director/Senior Medical Director, Clinical Development

Cullinan Therapeutics

4d•$300,000 - $390,000•Remote

About The Position

Cullinan Therapeutics is a biopharmaceutical company focused on developing innovative therapies for cancer and autoimmune diseases. The Medical Director/Senior Medical Director will be a key member of the clinical development team, specifically for an AML T-cell engager program. This role requires a high degree of independence, clinical judgment, and ownership in areas such as study strategy, execution, medical monitoring, data interpretation, and regulatory preparation. The individual will report to the Executive Medical Director.

Requirements

MD, DO, or equivalent medical degree with experience in patient care at the graduate medical level and beyond.
Board certification or substantial clinical experience in hematology, medical oncology, hematology-oncology.
At least 3-5 years of experience in clinical investigation in a pharmaceutical or biotechnology company, or equivalent academic clinical trial leadership experience.
Experience in oncology drug development, clinical trial design, medical monitoring, and interpretation of safety and efficacy data.
Working knowledge of Good Clinical Practice, clinical trial conduct, and regulatory expectations for oncology development.
Demonstrated ability to make independent, timely, and appropriate decisions in a fast-paced biotechnology environment.
Excellent interpersonal, verbal, and written communication skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.

Nice To Haves

The Senior Medical Director level typically requires broader independent program leadership experience.
Direct experience in AML, myeloid malignancies, or leukemia drug development.
Experience with T-cell engager, bispecific antibody, cellular therapy, or other immune effector therapies, including CRS/ICANS risk management.

Responsibilities

Serves as the medical monitor for clinical trials and assists in resolving major issues that may affect their assigned studies.
Partners with the Clinical Scientist, Data Manager, Pharmacovigilance Scientist, and other members of the study team to conduct the clinical studies, including study design, operational feasibility assessment, and site selection.
Provides expert opinion and review for creation of key study documents, including clinical study protocols, safety and medical monitoring plans, charters, and informed consent forms.
Interacts closely with Regulatory Affairs to contribute or review clinically relevant components of investigator brochures, briefing books, and other regulatory documents and communications.
Working with other members of the clinical study team, conducts investigator meetings, leads site initiation visits, and maintains relationships with clinical trial investigators.
Works with internal discovery and translational scientists, technical operations/manufacturing teams, regulatory affairs, safety and pharmacovigilance, and external consultants or CROs in a cross-functional manner.
Working closely with the Clinical Research Scientist and other members of the clinical study team (data management, biostatistics, and others), oversees and supports the gathering, analyzing, reviewing, interpreting, and reporting of clinical safety and efficacy data.
Supports publication and external communication strategy, acting as owner of clinical data, collaborating in the creation of meeting abstracts, presentations, and publications, and presenting at investigator meetings and scientific conferences as required.