Neurology Clinical Development Lead: Medical Strategy

Vertex Pharmaceuticals Inc (US); United States; Hybride; USD 281 000 - 421 000; Plein temps

Avantages offerts par ce poste

Hybrid-Eligible

On-Site Eligible Flex

Résumé du poste

Vertex Pharmaceuticals Inc (US) seeks a Senior Medical Director to define the clinical development strategy for assets, lead cross-functional teams, and drive trial design, execution, and regulatory submissions. This role may serve as Medical Lead for pivotal trials and interfaces with regulatory authorities.

The candidate will guide global clinical research, oversee safety monitoring, and contribute to business development.

Qualifications

• MD, DO or equivalent ex-US medical degree.
• Board certification/eligibility in a specialty is highly desired.
• Typically requires 12 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs.

Responsabilités

• Defines a clinical development strategy and prepares the clinical development plans, in conjunction with other relevant functional areas.
• 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 sections of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate.
• Monitors and/or oversees medical monitoring of clinical studies.
• Represents Vertex to outside medical personnel in the development of clinical protocols and study conduct.

Connaissances

Global clinical research experience

Excellent communication skills

Team collaboration

Independent problem solving

Ambiguity management

Regulatory interactions

Formation

MD/DO or equivalent ex-US degree

Board certification/eligibility

Description du poste

Vertex Pharmaceuticals Inc (US) seeks a Senior Medical Director to define the clinical development strategy for assets, lead cross-functional teams, and drive trial design, execution, and regulatory submissions. This role may serve as Medical Lead for pivotal trials and interfaces with regulatory authorities.

The candidate will guide global clinical research, oversee safety monitoring, and contribute to business development.