Sr. Medical Director/Executive Director, Early Clinical Development
$294,483–$444,486 year
On-site · Somerset, New Jersey, United States
Job Summary
Lead the Early Clinical Development Team and oversee IND submissions, design, and execution of first-in-human, dose-finding clinical trials in hematology/oncology with a focus on cellular therapies (CAR-T, TCR-T, NK) and related biomarker plans. Provide clinical leadership for study protocols and clinical study reports, clinical study safety monitoring, regulatory documentation and interactions, and cross-functional collaboration with scientists and investigators. Represent the project in internal and external venues, support business development and partnerships, and champion high standards of compliance, ethics and patient safety. Travel up to 15-20% and work with cross-functional teams to ensure successful program delivery. Requires MD/MD-PhD, US board certification in hematology/oncology, and extensive experience in early clinical development, IND processes, and cross-functional leadership; sub-specialization in cell therapies or CAR-T is highly desirable; strong written and spoken communication skills and a track record of publications; ability to operate across multiple geographies.
Required Qualifications
- MD or MD-PhD or equivalent medical degree with US board certification in hematology and/or oncology
- 3+ (Senior) / 6+ (Executive) years’ industry/ academic clinical development experience in hematology/oncology, leading cross-functional development teams
- Sub-specialization and/or clinical development experience in cell therapies or CAR-T is highly desirable
- Experience in biotech - preferred but not required
- Demonstrated excellence and experience in first-in-human clinical development including the design, execution of first in human trial, and submission of INDs
- Experience leading pre-IND and IND meetings with health authorities is highly desirable
- Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills
- Travel requirement up to 15-20 % of the time
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