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Associate Medical Director, Cystic Fibrosis Clinical Development

Hampton Research

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Boston, MA
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Job Description

As posted by the hiring company

Job Overview:

Job Description

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 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


MINIMUM QUALIFICATIONS:
• 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

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.