Director Jobs

About The Position

Requirements

• MD, DO, or equivalent ex-US medical degree.
• Typically requires 8 years of basic or clinical research experience in an academic or industry setting, or an equivalent combination of education and experience.
• Strong oral and written communication skills.
• Ability to work collaboratively in a fast-paced, team-based matrix environment and independently as appropriate.
• Working familiarity with research data analysis, biostatistics, pharmacology and pharmacokinetics, Good Clinical Practice (GCP), clinical study design, ethics committee/Institutional Review Board review, manuscript preparation, abstracts/posters, oral presentations, and overall drug/device clinical development.

Nice To Haves

• Global clinical research experience and experience interacting with regulatory authorities.
• Board certification or eligibility and clinical training in a relevant medical specialty is highly desired.

Responsibilities

• Participate, with minimal guidance, in developing study protocols, Investigator's Brochures, Clinical Development Plans, and other key documents with other line functions.
• Serve on cross-functional Study Execution Teams for assigned trials and work with team members to support efficient, high-quality study execution.
• Participate in preparing regulatory submission documents, including clinical sections of INDs and CTAs, IND safety reports, annual reports, responses to regulatory authorities and Ethics Committees/IRBs, and other appropriate documents.
• Provide scientific and clinical input to study-related documents and analysis plans, including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reports.
• Act as a liaison between Clinical Development and other internal Vertex groups, including Regulatory Affairs and Clinical Development Execution, for assigned studies.
• Represent Vertex to outside medical personnel in developing clinical protocols, conducting studies, and externally reporting study results.
• Perform other duties related to other aspects of Clinical Development as assigned.

Benefits

• Eligible for an annual bonus and annual equity awards.
• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in summer and winter.
• Educational assistance programs, including student loan repayment.
• Commuting subsidy.
• Matching charitable donations.
• 401(k).
• Some roles may be eligible for overtime pay in accordance with federal and state requirements.