Vertex Pharmaceuticals
Executive Medical Director, Patient Safety (Hybrid)
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Overview
Executive Medical Director, Patient Safety (Hybrid) — Vertex Global Patient Safety. This role will oversee safety and benefit-risk activities for GPS teams, contribute to consistency and compliance in safety assessment, analysis and reporting across Vertex world markets, and oversee GPS DASH/DST teams to ensure timely execution of Benefit-Risk activities, pre-marketing risk assessment, planning for First-In-Human studies, safety content in regulatory submissions, and post-approval safety requirements. The role reports to the GPS Senior Leadership Team and collaborates with cross-functional leaders to achieve strategic goals. Key Duties And Responsibilities
Provide leadership and oversight of DASH/Disease-area Safety Team(s) (DST) for all products, including pre-FIH activities, key benefit-risk assessment, and strategy development to meet goals. Coordinate and oversee consistent and timely review of safety data to identify new safety signals per Vertex signal detection practices. Collaborate with Clinical Leaders to develop and implement risk management procedures/plans for pre- and post-approval needs. Collaborate with NDA teams on assessment, strategy, and execution of regulatory documents, including leading safety content of key Modules (SCS, CLO, Labelling) and development of REMS, RMPs or equivalent documents. Collaborate with GPS Epidemiology on development, implementation and reporting of pharmacoepidemiology studies as needed. Review and/or assist in preparation of DSURs/PSURs/PBRERs, IND packages, NDA submissions, and related materials. Provide safety input for labeling documents (IB, CCDS, USPI, SmPC) as applicable. Collaborate with Regulatory Affairs to develop responses to safety-related regulatory inquiries. Provide medical review of aggregate and post-marketing and clinical trial adverse event reports according to GPS practices. Oversee medical evaluation of safety information from toxicology, non-clinical studies and product quality sources. Review safety content for key study documents (Protocols, SAP, IB, ICF, IDMC Charter) and study reports. Oversee analysis and representation of safety data in Clinical Study Reports and safety sections of CSRs. Contribute to Partner/Affiliate agreements and interactions as needed. Serve as Subject Matter Expert in SOPs and Work Instructions development; lead medical staff in adverse event processing from a medical perspective. Lead and guide direct reports on the scope of DASH/DST Chair responsibilities and provide sound medical input for pre- and post-marketing activities. Support staff development and growth. Knowledge And Skills
Extensive knowledge of GCP, ICH and global regulations. In-depth knowledge of General Medicine. Strong leadership and matrix collaboration skills. Experience in critical data evaluation and synthesis into clear messaging. Extensive knowledge of Benefit-Risk strategies and decision-making. Ability to multi-task and manage multiple demands. Education And Experience
MD, DO or equivalent ex-US medical degree 12+ years of work experience with Pharmacovigilance experience and 7 years of supervisory/management experience, or equivalent combination Pay Range
$312,000 - $468,000 Disclosures And Benefits
The posted pay range is a reasonable base salary estimate for the position at posting. The role is eligible for an annual bonus and equity awards. Benefits include medical, dental, vision, paid time off, educational assistance, 401(k) plans and other programs. Overtime eligibility and final base pay will depend on skills, experience and applicable law. Vertex offers Total Rewards and flexible benefits to support employees across career stages and locations. This includes a company shutdown period in Summer and Winter, and resources to support growth and wellbeing. Flex Designation
Hybrid-Eligible or On-Site Eligible Flex Eligibility Status
In this Hybrid-Eligible role, you may be designated as Hybrid (remote up to two days per week) or On-Site (five days per week on-site with ad hoc flexibility). Note: The Flex status for this position is subject to Vertex’s Flex @ Vertex Program and may change 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. Vertex is an E-Verify Employer in the United States and will provide reasonable accommodations for qualified individuals with known disabilities as required by law. Applicants may request accommodations during the hiring process by contacting Talent Acquisition. Location
Boston, MA
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Executive Medical Director, Patient Safety (Hybrid) — Vertex Global Patient Safety. This role will oversee safety and benefit-risk activities for GPS teams, contribute to consistency and compliance in safety assessment, analysis and reporting across Vertex world markets, and oversee GPS DASH/DST teams to ensure timely execution of Benefit-Risk activities, pre-marketing risk assessment, planning for First-In-Human studies, safety content in regulatory submissions, and post-approval safety requirements. The role reports to the GPS Senior Leadership Team and collaborates with cross-functional leaders to achieve strategic goals. Key Duties And Responsibilities
Provide leadership and oversight of DASH/Disease-area Safety Team(s) (DST) for all products, including pre-FIH activities, key benefit-risk assessment, and strategy development to meet goals. Coordinate and oversee consistent and timely review of safety data to identify new safety signals per Vertex signal detection practices. Collaborate with Clinical Leaders to develop and implement risk management procedures/plans for pre- and post-approval needs. Collaborate with NDA teams on assessment, strategy, and execution of regulatory documents, including leading safety content of key Modules (SCS, CLO, Labelling) and development of REMS, RMPs or equivalent documents. Collaborate with GPS Epidemiology on development, implementation and reporting of pharmacoepidemiology studies as needed. Review and/or assist in preparation of DSURs/PSURs/PBRERs, IND packages, NDA submissions, and related materials. Provide safety input for labeling documents (IB, CCDS, USPI, SmPC) as applicable. Collaborate with Regulatory Affairs to develop responses to safety-related regulatory inquiries. Provide medical review of aggregate and post-marketing and clinical trial adverse event reports according to GPS practices. Oversee medical evaluation of safety information from toxicology, non-clinical studies and product quality sources. Review safety content for key study documents (Protocols, SAP, IB, ICF, IDMC Charter) and study reports. Oversee analysis and representation of safety data in Clinical Study Reports and safety sections of CSRs. Contribute to Partner/Affiliate agreements and interactions as needed. Serve as Subject Matter Expert in SOPs and Work Instructions development; lead medical staff in adverse event processing from a medical perspective. Lead and guide direct reports on the scope of DASH/DST Chair responsibilities and provide sound medical input for pre- and post-marketing activities. Support staff development and growth. Knowledge And Skills
Extensive knowledge of GCP, ICH and global regulations. In-depth knowledge of General Medicine. Strong leadership and matrix collaboration skills. Experience in critical data evaluation and synthesis into clear messaging. Extensive knowledge of Benefit-Risk strategies and decision-making. Ability to multi-task and manage multiple demands. Education And Experience
MD, DO or equivalent ex-US medical degree 12+ years of work experience with Pharmacovigilance experience and 7 years of supervisory/management experience, or equivalent combination Pay Range
$312,000 - $468,000 Disclosures And Benefits
The posted pay range is a reasonable base salary estimate for the position at posting. The role is eligible for an annual bonus and equity awards. Benefits include medical, dental, vision, paid time off, educational assistance, 401(k) plans and other programs. Overtime eligibility and final base pay will depend on skills, experience and applicable law. Vertex offers Total Rewards and flexible benefits to support employees across career stages and locations. This includes a company shutdown period in Summer and Winter, and resources to support growth and wellbeing. Flex Designation
Hybrid-Eligible or On-Site Eligible Flex Eligibility Status
In this Hybrid-Eligible role, you may be designated as Hybrid (remote up to two days per week) or On-Site (five days per week on-site with ad hoc flexibility). Note: The Flex status for this position is subject to Vertex’s Flex @ Vertex Program and may change 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. Vertex is an E-Verify Employer in the United States and will provide reasonable accommodations for qualified individuals with known disabilities as required by law. Applicants may request accommodations during the hiring process by contacting Talent Acquisition. Location
Boston, MA
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