Sr. Medical Director, Clinical Development

Role Summary

Sr. Medical Director, Clinical Development. This role provides 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 site personnel; building relationships with external experts; and interacting with Health Authority representatives.

Responsibilities

• Provide medical leadership for various programs from first-in-human studies through registrational studies. Late-stage development experience is preferrable
• Formulate study designs, lead protocol development, partner with internal cross-functional teams in study start-up activities, and collaborate with clinical investigators, key external experts, and Health Authorities
• Participate in direct, hands-on involvement in all aspects of study conduct clinical activities, working with clinical operations, including data review, analysis, and reporting that conform to the ethical, safety, and quality standards of Cabaletta, GCP, and Health Authorities
• Become an expert and remain current in the relevant therapeutic areas and in the field of cell and gene therapy through review of the scientific literature, interactions with key external experts, and attendance at relevant scientific meetings
• Actively contribute during Health Authority interactions
• Review available preclinical data that could inform the design of future clinical trials
• Present at site evaluation and site initiation visits as applicable
• In partnership with relevant cross-functional team members, actively engage in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and BLA submission documents
• Collaborating with cross-functional groups, formulate publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data

Qualifications

• M.D., M.D./Ph.D. degree 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 the design and execution of complex clinical trials, with a pharmaceutical or biotech company
• Experience with or exposure to the development of 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; and ability to present at conferences and advisory meetings
• Independent, proactive, and goal-oriented; ability to work in a dynamic environment
• Ability to multi-task and contribute to multiple facets of drug development; willingness to learn new therapeutic areas and technologies
• Self-motivated, innovative, and analytical thinker with strong organizational and problem-solving skills
• Strong influencing skills and ability to provide clear direction
• Thrives in a fast-paced small company environment with ability to adjust priorities
• Comfortable with ambiguity and ability to define processes from scratch
• Strong team orientation and commitment to continuous self-development
• Ability and willingness to travel as required

Skills

• Clinical trial design and execution
• Regulatory interactions and submissions
• Cross-functional collaboration (clinical operations, regulatory, translational research, manufacturing, QA)
• Scientific leadership and communication

Education

• M.D., M.D./Ph.D. or equivalent