Patient Safety Epidemiology Associate Director

Job Description

General

Summary:

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.

General

Summary:

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

• 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

• 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

$0 - $0

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…