Patient Safety Medical Director

Job Description

General Summary:

The Senior Medical Director, Patient Safety, Disease Area Safety Head (DASH) will lead all safety and benefit-risk related activities for products within the role's Disease-area and/or Franchise, including pre-franchise products from first in-human clinical trials, into and throughout commercialization. This role will assist Global Patient Safety (GPS) Leadership in ensuring the consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex's world markets. Directly and/or via oversight of direct reports, the role will lead pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with the program specific Clinical Teams, Medical Affairs, and Partners (as applicable) to proactively assess and address potential and identified safety issues for each product throughout the product life cycle.

Key Duties and Responsibilities:

• Provides leadership and oversight of Safety Team(s) for products within assigned therapeutic area(s), including pre-FIH activities, benefit-risk assessment, and strategy for DSTs.
• Coordinates and oversees safety signals detection, in accordance with Vertex signal detection practices.
• Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, as needed.
• Collaborates with NDA teams in support of submissions, specifically leading development of any SCS, CLO, Label and Risk Management Plan (RMP) or equivalent documents.
• Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies.
• Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (D/PSURs), IND packages, as well as NDA and IND, MAA Annual Safety Reports.
• Provides review and safety-specific input for labeling documents.
• Collaborates with Regulatory Affairs to develop responses to safety related regulatory agency inquiries.
• Provides and oversees medical review of aggregate and individual post-marketing and clinical trial AE reports, in accordance with GPS review practices.
• Conducts medical evaluation of relevant safety information from Toxicology, Non-Clinical studies and Product Quality sources.
• Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Analysis Plan, IB, ICF and IDMC Charter.
• Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and Study Reports.
• Provides contributory to Partner /Affiliate agreements and interactions, as needed.
• Serves as Subject Matter Expert in departmental activities, SOP development.
• Facilitates the growth and development of staff and direct reports.

Knowledge and Skills:

• Broad and comprehensive knowledge of General Medicine
• Extensive knowledge of GCP, ICH and Global regulations
• Strong leadership skills with the ability to communicate effectively in a matrix environment
• Experience in the critical evaluation and interpretation of data, with ability to synthesize into coherent messaging
• Comprehensive knowledge of Benefit-Risk strategies and decision-making
• Ability to multi-task, adeptly handling multiple demands

Education and Experience:

• Doctorate in Medicine (M.D.) required
• Typically requires 7 years of work experience with some experience in Pharmacovigilance and 5 years of supervisory/management experience, or the equivalent combination of education and experience

Pay Range:
$276,000 - $414,000

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:
Hybrid-Eligible Or On-Site Eligible

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