Sr. Medical Director, Clinical Development

Role Summary

Senior Medical Director, Clinical Development responsible for medical oversight and leadership of Cabaletta's cell therapy programs in autoimmune diseases. Collaborates with clinical operations, regulatory, translational research, manufacturing, and quality assurance; liaises with clinical investigators, site personnel, external experts, and Health Authorities (e.g., FDA). Requires extensive experience working with CROs and vendors and interfacing with investigator sites in a fast-paced environment.

Location

Philadelphia, PA; this role can be remote or based at the Philadelphia headquarters. East Coast candidates preferred. Travel 10-20% required.

Responsibilities

• Provide medical leadership for programs from first-in-human studies through registrational studies; late-stage development experience preferred.
• Formulate study designs, lead protocol development, and partner with cross-functional teams in study start-up; collaborate with clinical investigators, external experts, and Health Authorities.
• Direct hands-on involvement in all aspects of study conduct, including data review, analysis, and reporting aligned with Cabaletta, GCP, and Health Authority standards.
• Remain current in relevant therapeutic areas and the field of cell and gene therapy through literature review, expert interactions, and scientific meetings.
• Actively contribute during Health Authority interactions.
• Review preclinical data to inform future trial design.
• Present at site evaluation and site initiation visits as applicable.
• Prepare Clinical Study Reports, Annual Reports, safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and regulatory submission documents.
• Collaborate with cross-functional groups to develop publication strategies, including authoring and reviewing manuscripts, abstracts, and presentations of clinical data.

Qualifications

• M.D., M.D./Ph.D. or equivalent required.
• Board Certification, Board Eligibility, or clinical experience in Rheumatology and/or Immunology highly desirable.
• 7+ years of experience in clinical research, including design and execution of complex clinical trials in pharma/biotech.
• Experience with adoptive cell therapies or biologic therapies is desirable.
• Experience with Health Authority interactions and submission of clinical regulatory documents is desirable.
• Strong written and verbal communication skills; ability to engage with investigators and external experts; effective at conferences and advisory meetings.
• Engaged, hands-on, independent, goal-oriented mentality; ability to thrive in a dynamic environment.
• Ability to multi-task and contribute to multiple facets of drug development; willingness to learn new areas and technologies.
• Self-motivated, innovative, analytical, and with strong follow-up, organizational, and problem-solving skills.
• Strong influencing skills and ability to provide clear direction.
• Thrives in a fast-paced small company; able to adjust priorities and workload as needed.
• Comfortable with ambiguity and ability to define processes from scratch.
• Strong team orientation and commitment to self-development.
• Ability and willingness to travel as required.

Skills

• Strategic medical leadership across early to registrational development.
• Cross-functional collaboration with clinical operations, regulatory, translational research, manufacturing, and quality assurance.
• Experience with CROs, vendors, and investigator-site interactions.
• Regulatory communications and Health Authority engagement.
• Publication planning and scientific communication.

Education

• M.D., M.D./Ph.D. or equivalent.

Additional Requirements

• Travel 10-20% as required.