Medical Director, Early Clinical Development (Cell Therapy)
Menlo Park, CA preferred, but open to remote candidatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 3+ years of industry experience
- Required Skills
- Project Management
Requirements
- MD, PhD or PharmD required; preferably a trained hematologist and/or oncologist.
- 3+ years of industry experience and expertise in cell therapy, bone marrow transplantation (BMT), or immune disorders preferred, including with early-stage trials.
- Self starter with an entrepreneurial mindset.
- Strong project management skills, with the ability to handle multiple priorities and timelines, work independently and drive initiatives.
- Excellent verbal and written communication skills, with the ability to engage and motivate clinical site teams.
- Willingness to travel as needed to meet with clinical sites and stakeholders.
Responsibilities
- Support strategic planning and execution of clinical strategy.
- Develop clinical trial protocols, statistical analysis plans, investigator brochures, and other documentation for early stage trials.
- Develop and present CRO/CRA/site training materials and present at Investigator Meetings/site initiation visits as required.
- Provide leadership to a Clinical Trial Manager (CTM) and Clinical Research Associate (CRA) dedicated to early stage programs.
- Medical monitoring, review, and analysis.
- Interpret early stage clinical data and provide an ongoing assessment of pre-clinical, clinical, scientific literature to inform clinical strategy and ensure positive benefit-risk profile for assigned programs in collaboration with key stakeholders.
- Collaborate with Regulatory, Operations, Safety, Medical team to provide oversight, prepare reports, and ensure all milestones are met.
- Work collaboratively with all internal and external stakeholders.
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