POSITION SUMMARY

The Medical Director will serve as a clinical leader, providing medical and scientific expertise to support the development of our in vivo CAR-T therapy programs. This individual will play a critical role in clinical strategy, study design, execution, and regulatory interactions while partnering cross-functionally with R&D, Clinical Operations, Regulatory, and Program Leadership teams. The ideal candidate will bring deep experience in cell & gene therapy and a strong track record in oncology or rheumatology clinical development.

We will consider candidates at either the Director or Senior Director level based on candidate's qualifications and experiences.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Provide medical leadership and clinical oversight for ongoing and planned in vivo CAR-T therapy programs.
• Contribute to the clinical development strategy, including indication selection, trial design, and endpoints.
• Serve as medical monitor for clinical studies, ensuring patient safety, data integrity, and compliance with GCP and regulatory requirements.
• Lead preparation of clinical protocols, investigator brochures, clinical sections of regulatory filings (IND, CTA, BLA), and other medical documents.
• Partner with Clinical Operations on trial execution, including site and investigator engagement, medical monitoring, and data review.
• Engage with global regulatory agencies to support program advancement.
• Provide scientific and clinical expertise to business development, investor relations, and partnership discussions as needed.
• Collaborate closely with translational medicine, preclinical, and regulatory teams to align clinical strategy with scientific discoveries.
• Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology.
• Work with external program partners collaboratively and effectively to deliver on contractual obligations while moving toward corporate goals and priorities.

 The successful candidate will have:

• Director Level: MD, MD/PhD, or equivalent medical degree. Board certification in Oncology, Hematology, or related specialty strongly preferred. 2-5 years of clinical development experience, including at least 2 years in the biotechnology or pharmaceutical industry.
• Senior Director Level: MD, MD/PhD, or equivalent medical degree. Board certification in Oncology, Hematology, or related specialty strongly preferred. Minimum of 5 years of clinical development experience, including at least 4 years in the biotechnology or pharmaceutical industry.
• Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities; experience in in vivo gene delivery a plus.
• Direct experience in oncology clinical trial design, execution, and medical monitoring.
• Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies.
• Proven ability to interact with investigators, KOLs, and regulatory authorities.
• Excellent communication, leadership, and cross-functional collaboration skills.
• Passion for innovation and commitment to advancing transformative therapies for patients.

Physical Requirements:  

• Ability to travel at least 6x per year to site initiation visits, domestic and international conferences, ad boards, etc
• Ability to work onsite at least 2 days/week

Director Salary Range: $250,000 - $313,000
Senior Director Salary Range: $270,000 - $333,000