Clinical Development Senior Medical Director-Neurology

Vertex Inc.•Boston, MA

5d•Hybrid

About The Position

The Senior Medical Director will define the clinical development strategy of an asset, work with cross-functional multidisciplinary teams to define overall asset strategy as well as clinical trials strategy, design and execution, and may serve as the Medical Lead for clinical trials that will be conducted with these compounds.

Requirements

MD, DO or equivalent ex-US medical degree
Typically requires 12 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs, or the equivalent combination of education and experience
Global clinical research experience, and experience interacting with regulatory authorities is highly desired
Ability to work collaboratively in a fast-paced, team-based matrix environment
Ability to work independently to resolve challenges
Enterprise-wide thinking and ability to work in ambiguity
Ability to ensure the completeness of team work
Excellent oral and written communication skills

Nice To Haves

Board certification/eligibility in a specialty is highly desired

Responsibilities

Defines a clinical development strategy and prepare the clinical development plans, in conjunction with other relevant functional areas
Participates 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
Leads the Project Team, and works with cross-functional team members to define a project strategy and ensure execution against approved strategy
Participates 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
Interfaces with regulatory authorities as appropriate
Monitors and/or oversees medical monitoring of clinical studies
Participates in business development and strategic planning activities
Acts as liaison between clinical development and other internal groups at Vertex for assigned studies
Provides medical and development leadership for cross-functional teams
Serves on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
Represents Vertex to outside medical personal in the development of clinical protocols and study conduct