Endocrinology Clinical Development Medical Director

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 240,000 - 360,000; Full time

Job summary

Vertex is seeking a Clinical Development Medical Director to serve as the Medical Lead for Vertex clinical trials in the Boston area. You will guide trial strategy, design and execution across Phases, working with cross-functional teams on high-quality study conduct.

The role requires MD/DO or equivalent, board certification in a medical specialty, and roughly a decade of clinical or research experience. Vertex offers a hybrid/onsite structure, competitive compensation, and comprehensive

Qualifications

• MD, DO or equivalent medical degree.
• Board certification/eligibility in a medical specialty (endocrinology or pediatrics) is highly desirable.
• Typically requires 10 years of clinical/research experience in academic or industrial settings.
• Working knowledge of biostatistics, GCP, and clinical study design.

Responsibilities

• Leads the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance
• Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution
• Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical sections of INDs and CTAs, safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
• Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR). Acts as liaison between Translational Medicine/Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Operations) for assigned studies
• Represents Vertex to outside medical personnel in the development of clinical protocols and study conduct
• Performs other duties as assigned related to clinical programs

Skills

Communication skills

Collaborative teamwork

Cross-functional collaboration

Endocrinology knowledge

Education

MD/DO or equivalent

Board certification/eligibility in a medical specialty

10+ years of clinical/research experience

Job description

Vertex is seeking a Clinical Development Medical Director to serve as the Medical Lead for Vertex clinical trials in the Boston area. You will guide trial strategy, design and execution across Phases, working with cross-functional teams on high-quality study conduct.

The role requires MD/DO or equivalent, board certification in a medical specialty, and roughly a decade of clinical or research experience. Vertex offers a hybrid/onsite structure, competitive compensation, and comprehensive