Executive Medical Director, Patient Safety page is loaded Executive Medical Director, Patient Safety Apply locations Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id REQ-22226
Job Description
The Executive Medical Director, Disease-Area Safety Head (Physician) will lead all safety and benefit-risk related activities for products within the role's Disease-area and/or Franchise, directly and/or via oversight of direct reports, including pre-franchise products from first in-human clinical trials, into and throughout commercialization. The role will assist GPS Leadership in ensuring 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 also lead the strategy and development of the pre-marketing risk assessment, planning for First-In-Human studies, and oversight of safety content of key Modules (SCS, CLO, Labeling) 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 Research Physicians and their Teams, Medical Affairs leaders and their teams, 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:
Leads and oversees Disease-area Safety Team(s) (DST), directly or direct reports, for all products within assigned therapeutic area(s). Including pre-FIH activities, key benefit-risk assessment, and providing strategy for DSTs to meet goals and objectives.
Coordinates and oversees the regular 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 assist 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.
Conducts 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 liaises 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 GPS 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.
Oversee Aggregate Report & Risk Management Group and deliverables as designated by Head of GPS
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.
Solid 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
Typically requires 10 years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience, or the equivalent combination of education and experience
We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:
1. Hybrid and work remotely up to two days per week; or select
2. On-Site and work 5 days per week with ad hoc flexibility.
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 person's 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 .
Similar Jobs (1) Medical Director, Patient Safety locations Boston, MA time type Full time posted on Posted 2 Days Ago
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases - cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia - and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook , Twitter/X , LinkedIn , YouTube and Instagram .
The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.
Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.