Associate Medical Director, Clinical Development, Cystic Fibrosis (CF)
Vertex Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- Participates in the development of Study Protocols, Investigator's 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 section of IND’s and CTA’s, IND 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 Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) 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 AATD clinical programs
- MD, DO or equivalent ex-US medical degree
- Board certification/eligibility in pulmonary, gastrointestinal medicine, infectious diseases, or another relevant medical field, is highly desired; clinical Cystic Fibrosis experience is a plus
- At least 3 - 5 years of basic or clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of Good Clinical Practice, scientific and clinical research methods and clinical study design
- Excellent oral and written communication skills
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
- Global clinical research experience and experience interacting with regulatory authorities is a plus