The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials.
The incumbent will work on multiple trials in all Phases of clinical development, and may also participate in other selected projects in clinical development.
- Leads the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance
- Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution
- Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical sections of INDs and CTAs, safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
- Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR). Acts as liaison between Translational Medicine/Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Operations) for assigned studies
- Represents Vertex to outside medical personal in the development of clinical protocols and study conduct
- Performs other duties as assigned related to clinical programs
- Excellent oral and written communication skills
- Ability to work collaboratively in a fast-paced, team-based, matrix environment and to function independently as appropriate
- Effective at building alliances across functions, based on end-to-end drug development thinking and experience
- Board certification/eligibility in a medical, pediatric or surgical subspecialty
- MD, DO or equivalent ex-US medical degree
- Board certification/eligibility in a specialty field is highly desired
- Typically requires 10 years of basic or clinical research experience in an academic or industrial setting, or the equivalent combination of education and experience
- Typically requires experience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design
- Typically requires experience with design, execution, and analysis of clinical trials required