Job Description

General Summary:

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.

Key Duties and Responsibilities:

• Broad and comprehensive understanding of the drug development process
• Well-respected authority in the external clinical development community
• 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.

Knowledge and Skills:

• 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
• Board certification/eligibility in a medical specialty desired

Education and Experience:

• 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

#LI-JM1

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid
 

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.

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 [email protected]