The Director, Epidemiology leads scientific contribution for epidemiology engagements and Real-World Studies, providing epidemiology content for proposals, capability presentations, bid-pursuit meetings, protocol development and analysis requirements. Facilitates study-design workshops, as well as harmonizes scientific input to proposals from other contributors including, but not limited to, medical, biostatistics, Clinical Outcome Assessment (COA) science, and market access. The Director, Epidemiology provides scientific guidance to Sponsors and internal project teams, and plays a key role in driving new business opportunities.

Director, Epidemiology contributes to Parexel’s participation in industry forums and thought-leadership engagements to advance Parexel’s epidemiology services and market positioning. Moreover, the Director, Epidemiology participates in developing and maintaining Parexel’s network of industry professionals and other collaborators, as well as contributes to the strategic development of the Epidemiology service line and leads selected parts of implementation plans for the department.

Key Accountabilities :

Accountability

Supporting Activities

Epidemiologic deliverables

• Develop and effectively communicate solutions, including study design conceptualization and protocol development, to meet Sponsor’s Epidemiology and Real-World Study needs
• Contribute to selection of appropriate secondary-data sources, and pharmacoepidemiology methods and analyses
• Lead development of project-specific study designs to meet Sponsors’ objectives for Epidemiological Real-World Studies (and other studies, as appropriate), ensuring high-quality scientific expertise and approach, within the appropriate operational and commercial contexts
• Contribute to or define planned analyses and requirements to support analyses for Epidemiological Real-World Studies, generally in collaboration with statisticians or other roles performing analyses, and roles responsible to provide analytics software and platforms
• Develop selected parts of deliverables for Epidemiological Real-World Studies, including study protocols and study reports (or supervises the development by a more junior epidemiologist)
• Review and comment on deliverables with Epidemiological content, including feasibility assessments, study protocols, statistical analysis plans, and study reports
• Facilitate study-design workshops for Epidemiological Real-World Studies, including preparation of the material for the workshop, leading the client interaction and summarizing the outcome of the workshop

Business-development support

• Effectively communicate Epidemiological considerations through written and oral contribution to proposals, capabilities, client engagement, and presentation at bid meetings
• Actively participate in proposal development by applying epidemiological expertise to the optimal design of Real-World Studies (and other studies, as appropriate), addressing key Epidemiologic questions around study / protocol design, epidemiologic-service models and others as appropriate, and by estimating the budget for the work of epidemiologists
• Lead development of responses to the epidemiologic and risk- management components of Requests for Proposals (RFPs) and Requests for Information (RFIs)

Cross-functional team support

• Support Parexel teams and staff in obtaining an appropriate level of understanding regarding sound Epidemiologic (and risk management, where applicable) principles, as agreed with upper management
• Serve as a senior-level scientific liaison to other functional service groups within Parexel (e.g., medical, biostatistics, pharmacovigilance, medical writing) requesting Epidemiologic support, as agreed with upper management, to ensure Real-World Studies incorporate appropriate Epidemiologic perspectives.
• Maintain a positive, results-oriented work environment while building partnerships through teamwork and communicating in an open, balanced and objective manner
• Develop and deliver training courses and materials on the role of Epidemiology in Real-World Studies, as agreed with upper management

Thought leadership

• Participate in developing and maintaining Parexel’s industry and collaborator network, as agreed with upper management
• Lead selected parts of Parexel’s Thought Leadership contributions, e.g. presentations, articles, posters, as agreed with upper management

Business strategy

• Contribute to the strategic development of the Epidemiology service line, as agreed with upper management
• Contribute to the development of highly competitive scientific and operational delivery models that optimize both internal and external validity, as agreed with upper management

Skills:

• Driven to deliver high-quality results on time and in a highly ethical and professional manner
• Ability to create a sense of urgency and take a proactive, solutions-based approach
• Strong interpersonal skills and the ability to quickly build and sustain positive relationships with customers and internal teams
• In-depth knowledge of the role of Epidemiology and Real-World Evidence applications across the biopharmaceutical and medical-device product lifecycle
• Demonstrated ability to strategically apply Epidemiology expertise in the determination of evidence gaps and design of real-world studies
• Demonstrated thought-leadership skills and ability to deliver high-quality industry and scientific publications and presentations
• Demonstrated ability to communicate complex ideas in a simple, understandable and compelling manner to both scientific and non-scientific audiences
• Demonstrated skill in Epidemiological project delivery
• Highly effective communication skills in English, both written and verbal, at all levels with customers, internally and with the industry at large
• Demonstrated ability to provide senior scientific support to study teams, direct more junior staff and value the importance of teamwork
• Comfortable operating in a demanding, fast-paced environment and capable of reacting swiftly to changing business demands
• Ability to thrive in a matrix environment and to value the importance of teamwork
• Demonstrated ability to digest information in a timely manner, assess it critically and provide thoughtful interpretations and guidance in meeting settings with customers and teams

Knowledge and Experience:

• 12+ years’ Epidemiology experience
• Experience in CRO, biopharmaceutical and/or medical-device industry setting(s)
• Significant experience in the application of expert epidemiologic knowledge to the conceptualization, design and successful delivery of epidemiology services in pharmacoepidemiology, Real-World research, risk management and pharmacovigilance
• Experience with key epidemiology study designs using different types of data sources across different global regions (e.g., prospective and retrospective comparative cohort studies, patient and physician surveys, cross-sectional studies)
• Remains current with evolution in industry on clinical data sources, methods and new and innovative study designs
• Remains current with regulatory and other industry positions on epidemiologic approaches and Real-World evidence
• Experience in adding value to epidemiologic study design and/or providing an innovative solution to Sponsor’s business needs in Real-World evidence generation and/or drug safety
• Demonstrated Thought Leadership and name recognition through published works and industry / scientific presentations
• Knowledge of regulations regarding pharmacovigilance, risk management and safety reporting; drug development; epidemiologic / non-interventional research methodologies; and pharmacoepidemiologic statistical-analysis models
• Experience working with Academic Institutions or Healthcare Providers a plus

Education:

• Advanced degree (i.e., MD/MPH, PhD, DrPH) in epidemiology