Senior Medical Director, Clinical Development

• Provide medical leadership for various programs from first-in-human studies through registrational studies
• 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

• D., M.D./Ph.D. degree or equivalent required
• Board Certification, Board Eligibility, or clinical experience in the field of 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 easily engage with investigators and key external experts
• and ability to effectively present at conferences, advisory meetings, and other public for a
• Engaged, hands-on, independent, and goal-oriented mentality
• willingness to work in highly dynamic work environment
• Ability to multi-task and willingness to flexibly contribute simultaneously to multiple facets of drug development
• willingness to learn new therapeutic areas and technologies
• Self-motivated, innovative, and critical thinker with strong commitment to follow up on action items
• strong organizational, analytical, and problem-solving skills
• Strong influencing skills and ability to create a clear sense of direction
• Thrives in a fast-paced small company environment and able to adjust priorities and workload based upon changing needs
• Comfortable with ambiguity and ability to define processes and procedures from scratch
• Strong team orientation and passion for continuous self-development
• Ability and willingness to travel as required

• 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
• Late-stage development experience is preferrable

health and retirement, PTO, and stock option plans