Executive Medical Director- Nephrology

Vertex Pharmaceuticals•Boston, MA

8d•Hybrid

About The Position

The Executive Medical Director, Clinical Development will provide high-level input on clinical development strategies to povetacicept renal programs, in conjunction with other relevant functional area leaders in Medical Affairs, Regulatory, Global Patient Safety, Clinical Operations, Exploratory Development, Commercial, Pharmaceutical Development, Research, Business Development, and Marketing. Initiate and lead innovative approaches to clinical development.

Requirements

Broad and comprehensive understanding of the drug development process
Well-respected authority in the external clinical development community
Global clinical research experience and experience interacting with regulatory authorities is highly desired
Possesses a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development process
Possesses a working knowledge of biostatistics, data management, clinical operations and clinical pharmacokinetic scientific and technical processes
Experience in filing and defending US INDs and/or NDAs and/or their international equivalents
Enterprise-wide thinking and ability to work in ambiguity, including being hands on in order to ensure the work that needs to be done by the team gets done; other duties as required or assigned
Ability to work and lead collaboratively in a challenging fast-paced, team-based matrix environment
Ability to work independently to resolve challenges and conflicts
Excellent oral and written communication
Excellent leadership skills
MD, DO or equivalent ex-US medical degree
15 years pharmaceutical industry experience, including time managing clinical trials and/or clinical development program(s), or the equivalent combination of education and experience
7 years of management experience

Nice To Haves

Board certification/eligibility in a medical specialty desired

Responsibilities

Provide clinical development recommendations to project teams, including optimizing study design and conduct for efficiency and effectiveness.
Participate in planning for worldwide clinical development activities
Provide guidance to multi-disciplinary development teams
Review study protocols
Review Investigator Brochures
Review and evaluate study subject exemptions
Oversee medical monitoring of clinical studies
Evaluate adverse events and overall safety profile
Participate in data reviews
Interface with international regulatory authorities, as appropriate, in support of the development objectives for the compound or program
Ensure compliance with Vertex Standard Operating Procedures, International Conference on Harmonization, Good Clinical Practice, and other national and international regulatory requirements
As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.