Job Description
General Summary :
The Associate Medical Director will serve as the Medical Lead for Vertex clinical trials in Cystic Fibrosis (CF), working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials.
This individual will work on multiple trials in Phases 1 through 3 and may also participate in selected projects in the CF clinical development program.
Key Duties and Responsibilities :
- 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
- Travel 2-3 times per year
Education and Experience :
- 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
8 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
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