[Hiring] Patient Safety Epidemiology Associate Director @Vertex Inc.

Role Description

The Patient Safety Epidemiology Associate Director leads safety and regulatory epidemiology activities for Vertex products across multiple therapeutic areas and throughout all phases of lifecycle. This includes execution of post-marketing regulatory study research strategies, leading comprehensive epidemiologic feasibility assessments, development of epidemiologic study designs, overseeing study implementation, interpretation of findings and communication to internal and external audiences.

• Major contributor and driver to the company safety risk management, signal detection, benefit/risk assessments, and post-marketing regulatory research strategies.
• Expected to research the epidemiology of specific disease areas and events of interest, lead evaluation of data sources and data collection approaches, apply subject matter expertise in the design of observational studies, develop epidemiology sections for regulatory documents, and lead the post-marketing regulatory research strategy implementation.
• Effectively communicates safety and regulatory epidemiologic strategy to product teams.
• Leads all stages of the design and implementation of regulatory post-marketing studies: from feasibility assessments, development of study designs and protocols, and execution of studies, to communication and dissemination of results to internal and external (e.g., Regulatory Agencies, scientific communities) stakeholders.
• Contributes to company publications strategy via development of conference abstracts, presentations, peer-reviewed manuscripts based on the findings of epidemiological studies.
• Leads the development of epidemiology sections for Risk Management Plans (EU RMP, REMS, etc.) and other regulatory filings (NDA, PSUR, etc.) for products throughout lifecycle.
• Leads systematic and targeted epidemiologic literature reviews to support safety evaluation and/or post-marketing research strategies.
• Supports signal detection analyses of safety reporting system databases (FAERS, Vigibase) or other sources (e.g. Sentinel).
• Leads study execution teams for post-marketing regulatory studies.
• Actively participates at strategic meetings including Disease Area Safety Teams and Global Patient Safety staff meetings.
• Collaborates cross-functionally to support company strategy for observational research, integrating innovative study methodologies.
• May supervise interns and/or contractors.

Qualifications

• Specialized knowledge in pharmacoepidemiologic methods, pharmacovigilance regulations, and specific therapeutic areas.
• Specialized knowledge of study design methodology in general medicine and clinical practice, evidenced by experience in designing/implementation of epidemiology studies.
• Strong knowledge in pharmacovigilance guidelines and regulations.
• Excellent verbal and written communication skills, including experience with scientific presentations and peer-reviewed publications, to translate epidemiologic research methods and results to diverse audiences.
• Excellent independent decision-making skills.
• Strong project management skills.
• Proven ability to build strong collaborative relationships with stakeholders and business partners and to work effectively in a diverse matrix environment.

Requirements

• PhD in epidemiology is required.
• Typically requires 5 years of experience in pharmaceutical/biotechnology industry, CRO, or academic setting or the equivalent combination of education and experience.

Benefits

• Annual bonus and annual equity awards.
• Eligible for overtime pay, in accordance with federal and state requirements.
• Inclusive market-leading benefits including medical, dental, and vision benefits.
• Generous paid time off (including a week-long company shutdown in the Summer and the Winter).
• Educational assistance programs including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) and more.

Flex Designation

• Remote-Eligible
• In this Remote-Eligible role, you can choose to be designated as:
  • Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site;
  • Hybrid: work remotely up to two days per week;
  • 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.