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Executive Medical Director, Patient Safety

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Friday, June 7, 2024

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.

#LI-Hybrid #LI-AR1

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 ApplicationAssistance@vrtx.com.