Clinical Development Associate Medical Director - AATD
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POST DATE 7/2/2020
END DATE 8/15/2020
Vertex Pharmaceuticals Inc (US)
JOB DESCRIPTIONThe Associate Medical Director will serve as the Medical Lead for Vertex clinical trials in AATD, 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 AATD clinical development program.
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 GCP, 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