Seeking a highly skilled Executive Medical Director, Oncologist & Hematologist MD to join their Clinical Development Organization. Reporting to Chief Medical Officer, this role will be central to the advancement of innovative gene-edited Universal CAR T-cell products
Responsibilities:
- Clinical Leadership: Oversee all clinical deliverables for assets/programs, guiding the development and execution of drug development strategies throughout all clinical stages.
- Protocol Development: Create and implement study protocols with clinical investigators, KOLs, and regulatory bodies to achieve scientific and corporate goals.
- Regulatory Documentation: Contribute to and review regulatory documents, including IND reports, safety reports, investigator brochures, and development plans.
- Medical Monitoring: Provide ongoing medical oversight for clinical trials, including eligibility assessments, toxicity management, and safety surveillance. Review serious adverse event reports for accuracy and completeness.
- Regulatory Compliance: Ensure adherence to regulatory requirements and Good Clinical Practice standards.
- Data Analysis: Coordinate the collection and analysis of clinical data, prepare and review study results, and contribute to NDA sections.
- Scientific Communication: Prepare presentations for scientific conferences, investigator meetings, and advisory meetings. Develop manuscripts for peer-reviewed journals.
- Program Guidance: Act as the scientific and clinical contact for assigned programs and provide guidance to clinical development, preclinical, regulatory, and project management teams.
- Continuous Learning: Stay updated on standards of practice in relevant therapeutic areas through literature review, KOL relationships, and scientific meetings.
Qualifications:
- Education: M.D. or MD/Ph.D. with 10-15 years of drug development experience in large pharma or biotech.
- Experience: Strong background in cellular and gene therapies is preferred. Proven track record in designing, running, and analyzing clinical trials, especially in biologics and immuno-oncology.
- Expertise: Board certification or eligibility in Oncology, Hematology, or related specialty is preferred. Experience with IND-enabling studies and early-phase clinical development.
- Regulatory Knowledge: Familiarity with FDA and EMA regulations and global regulatory authorities.
- Skills: Strong interpersonal, negotiation, problem-solving, and communication skills. Proficient in writing protocols, reports, and regulatory documents. Capable of working independently and as part of a team in a fast-paced, dynamic environment.
Location and Work Environment:
- Location: Based in New York, NY.
- Work Arrangement: Hybrid workplace with 4 days per week required onsite.
