Sr. Medical Director, Clinical Development
Cabaletta Bio
4 hours ago
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
Position Description
- Remote or based out of Philadelphia, PA headquarters (East Coast candidates preferred)
- Travel: 10–20% required
Senior Medical Director, Clinical Development
Key Responsibilities
- Provide medical leadership for programs from first-in-human through registrational studies (late-stage experience preferred)
- Formulate study designs and lead protocol development; partner with cross-functional teams on study start-up; collaborate with clinical investigators, external experts, and Health Authorities
- Hands-on involvement in clinical study conduct with Clinical Operations, including data review, analysis, and reporting aligned with ethical, safety, and quality standards (GCP and Health Authorities)
- Remain current in therapeutic areas and cell/gene therapy via literature review, expert interactions, and scientific meeting attendance
- Actively contribute during Health Authority interactions
- Review preclinical data to inform future clinical trial design
- Present at site evaluation and site initiation visits (as applicable)
- Prepare Clinical Study Reports, Annual Reports and safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and BLA submission documents
- Develop publication strategy; author/review manuscripts; create conference abstracts, presentations, and other external clinical data presentations
Qualifications
- M.D. or M.D./Ph.D. (or equivalent) required
- Board Certification/Eligibility or clinical experience in Rheumatology and/or Immunology highly desirable
- 7+ years clinical research experience designing/executing complex clinical trials (pharma/biotech)
- Experience with/adoption cell therapies or biologic therapies desirable
- Health Authority interaction and clinical regulatory document submission desirable
Required Skills/Attributes
- Strong written/verbal communication; engage investigators and external experts; present at conferences/advisory meetings/public forums
- Hands-on, independent, goal-oriented; thrives in dynamic environments
- Ability to multitask and flexibly support multiple facets of drug development; willingness to learn new therapeutic areas/technologies
- Self-motivated, innovative, critical thinker; strong follow-up, organizational, analytical, and problem-solving skills
- Strong influencing skills; ability to set clear direction
- Comfortable with ambiguity; ability to define processes from scratch
- Strong team orientation; passion for continuous self-development
Benefits
- Competitive benefits, PTO, and stock option plans
- Remote or based out of Philadelphia, PA headquarters (East Coast candidates preferred)
- Travel: 10–20% required
Senior Medical Director, Clinical Development
Key Responsibilities
- Provide medical leadership for programs from first-in-human through registrational studies (late-stage experience preferred)
- Formulate study designs and lead protocol development; partner with cross-functional teams on study start-up; collaborate with clinical investigators, external experts, and Health Authorities
- Hands-on involvement in clinical study conduct with Clinical Operations, including data review, analysis, and reporting aligned with ethical, safety, and quality standards (GCP and Health Authorities)
- Remain current in therapeutic areas and cell/gene therapy via literature review, expert interactions, and scientific meeting attendance
- Actively contribute during Health Authority interactions
- Review preclinical data to inform future clinical trial design
- Present at site evaluation and site initiation visits (as applicable)
- Prepare Clinical Study Reports, Annual Reports and safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and BLA submission documents
- Develop publication strategy; author/review manuscripts; create conference abstracts, presentations, and other external clinical data presentations
Qualifications
- M.D. or M.D./Ph.D. (or equivalent) required
- Board Certification/Eligibility or clinical experience in Rheumatology and/or Immunology highly desirable
- 7+ years clinical research experience designing/executing complex clinical trials (pharma/biotech)
- Experience with/adoption cell therapies or biologic therapies desirable
- Health Authority interaction and clinical regulatory document submission desirable
Required Skills/Attributes
- Strong written/verbal communication; engage investigators and external experts; present at conferences/advisory meetings/public forums
- Hands-on, independent, goal-oriented; thrives in dynamic environments
- Ability to multitask and flexibly support multiple facets of drug development; willingness to learn new therapeutic areas/technologies
- Self-motivated, innovative, critical thinker; strong follow-up, organizational, analytical, and problem-solving skills
- Strong influencing skills; ability to set clear direction
- Comfortable with ambiguity; ability to define processes from scratch
- Strong team orientation; passion for continuous self-development
Benefits
- Competitive benefits, PTO, and stock option plans