Executive Medical Director, Patient Safety (Hybrid)
Executive Medical Director, Patient Safety (Hybrid)
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$ 312000 - 468000
1 Vacancy
Job Description
Job Description
General Summary:
The Executive Medical Director Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team the role will contribute to ensuring consistency and compliance in the safety assessment analysis and reporting for all designated product(s) throughout Vertexs world markets. Overseeing the GPS DASH/DST teams across therapeutic areas the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST teams including 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 leaders from cross-functional teams on the successful achievement of key strategic activities initiatives and deliverables.
Key Duties and Responsibilities:
- Provides leadership and oversight of DASH/Disease-area Safety Team(s) (DST) conduct for all products across the Vertex Portfolio including pre-FIH activities key benefit-risk assessment and providing strategy for DSTs to meet goals and objectives.
- Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals in accordance with Vertex signal detection practices.
- Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product both pre-approval and post-approval as needed.
- Collaborates with NDA teams assessment strategy and execution of key Regulatory Authority documents in support of submissions specifically leading safety content of key Modules (SCS CLO Labelling) and development of any Risk Evaluation and Mitigation Strategy (REMS) Risk Management Plan (RMP) or equivalent documents.
- Collaborates with GPS Epidemiology with regards to development implementation and reporting of pharmacoepidemiology studies as needed.
- Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs PSURs/PBRERs) IND packages as well as NDA and INDs.
- Provides review and safety-specific input for labeling documents including IB CCDS USPI SmPC and other local labels as applicable.
- Collaborates with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.
- Provides and oversees medical review of aggregate and/or individual post-marketing and clinical trial adverse event reports in accordance with GPS review practices.
- Oversees medical evaluation of other relevant non-AE/SAE related safety information such as from Toxicology Non-Clinical studies and Product Quality sources.
- Reviews and provides oversight for medical content for key study-related documents e.g. Protocols Statistical 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 representation in Clinical Study Reports.
- Reviews and provides oversight of safety sections of clinical study reports.
- Provides a contributory role in Partner /Affiliate agreements and interactions as needed.
- Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development.
- Leads Medical staff and liaise with Operations leads regarding optimal practice regarding collection evaluation and processing of adverse experience reports from a medical perspective.
- Leads and guides direct reports regarding the scope of DASH/DST Chair Physician responsibilities and the provision of sound medical input for all pre-marketing and post-marketing activities.
- Facilitates the growth and development of staff and direct reports.
Knowledge and Skills:
- Extensive knowledge of GCP ICH and Global regulations.
- In-depth and comprehensive knowledge of General Medicine.
- 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 clear coherent messaging.
- Extensive knowledge of Benefit-Risk strategies and decision-making.
- Ability to multi-task adeptly handling multiple demands.
Education and Experience:
- MD DO or equivalent ex-US medical degree
- 12 years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience or the equivalent combination of education and experience
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Pay Range:
$312000 - $468000Disclosure 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 EligibleFlex 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 Vertexs Policy on Flex @ Vertex Program and may be changed at any time.
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 persons 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
Required Experience:
Director
Employment Type
Full-Time
