CF and General Medicines

Vertex Pharmaceuticals, Inc Boston, MA
Job Description

Vertex Pharmaceuticals is searching for an experienced Medical Director to assist in managing one or more assets in its general medicine portfolio. The Medical Director will assist with the clinical development strategy for clinical stage compounds, work with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution, and serve as the Medical Lead and primary Medical Monitor for clinical trials that will be conducted with these compounds.

KEY RESPONSIBILITIES:

* Prepare the clinical development plans, in conjunction with other relevant functional areas

* Participate in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidance

* Serve on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis

* Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate

* Interface with regulatory authorities as appropriate

* Act as liaison between clinical development and other internal groups at Vertex for assigned studies

* Provide medical and development leadership for cross-functional teams

* Represent Vertex to outside medical personal in the development of clinical protocols and study conduct

#LI-RS1

Minimum Qualifications

* MD, or DO

* Board certification/eligibility in hematology is highly desired

* Minimum of 3 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs

* Global clinical research experience and experience interacting with regulatory authorities is a plus

* Ability to work collaboratively in a fast-paced, team-based matrix environment

* Ability to work independently to resolve challenges

* Excellent oral and written communication skills