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, collaborating with clinical operations, regulatory, translational research, manufacturing, and quality assurance; liaising with clinical investigators and external experts; engaging with Health Authorities; and ensuring efficient trial execution in a fast-paced environment.

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, partner with cross-functional teams in study start-up, and collaborate with investigators, external experts, and Health Authorities
• Direct involvement in study conduct, including data review, analysis, and reporting that meet Cabaletta, GCP, and Health Authority standards
• Remain current in therapeutic areas and cell/gene therapy through literature review, external expert interactions, and attendance at scientific meetings
• Contribute to Health Authority interactions
• Review preclinical data to inform future trial design
• Present at site evaluation and initiation visits as applicable
• Prepare Clinical Study Reports, Annual Reports, safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and BLA submission documents
• Collaborate with cross-functional teams to formulate publication strategy and participate in manuscript, conference abstract, and presentation preparation

Qualifications

• M.D., M.D./Ph.D. or equivalent required
• Board Certification/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 desirable
• Experience with Health Authority interactions and regulatory submissions desirable
• Strong written and verbal communication; ability to engage with investigators and external experts; effective conference/advisory presentation skills
• Hands-on, independent, goal-oriented, adaptable to a dynamic environment
• Ability to multi-task and contribute to multiple facets of drug development; willingness to learn new areas
• Self-motivated, innovative, critical thinker with strong organizational, analytical, and problem-solving skills
• Strong influencing skills and ability to provide direction
• Thrive in a fast-paced small company; adjust priorities as needed
• Comfort 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

• Medical leadership in clinical development
• Study design and protocol development
• Regulatory affairs and Health Authority interactions
• Clinical operations oversight and data analysis
• Scientific communication and publication planning

Education

• MD and/or PhD (or equivalent)

Additional Requirements

• Travel of 10‚Äì20% required