Senior Director, Epidemiology

This position leads scientific contributions 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 and harmonizes scientific input to proposals from other contributors including, but not limited to, medical, biostatistics, COA science, and market access.

This position will actively participate in industry forums and thought-leadership engagements to advance Parexel’s epidemiology services and market positioning. They will develop a network of industry professionals to expand their sphere of influence within the industry and to contribute to the strategic development of the Epidemiology service line by identifying industry and client epidemiology needs. S/he assists the department head with the strategy development and implementation plans for the department and contributes their expertise to the development of innovative and highly competitive project-delivery models.

Accountability, Supporting Activities

Study designDevelop and effectively communicate solutions to meet Sponsor’s Epidemiology and Real-World Study needsContribute to selection of appropriate secondary-data sources, and pharmacoepidemiology methods and analysesLead development of project-specific study designs to meet Sponsors’ objectives, ensuring high-quality scientific expertise and approach, within the appropriate operational and commercial contextsContribute to or define planned analyses and requirements to support those analyses, generally in collaboration with statisticians or other roles performing analyses, and roles responsible to provide analytics software and platformsBusiness-development supportEffectively communicate Epidemiological considerations and actively participate in proposal development by applying epidemiological expertise to the optimal design of real-world studies. Lead development of responses to the epidemiologic and risk- management components of Requests for Proposals (RFPs) and Requests for Information (RFIs)ConsultingLead Consulting engagements with Sponsors, addressing key Epidemiologic questions around study / protocol design, epidemiologic-service models and others as appropriateLead engagements with internal teams requesting epidemiologic support related to ongoing or planned clinical trials, and with Pharmacovigilance in the development of aggregated safety reports and/or signal detectionProject and cross-functional team supportServe as a scientific mentor to Parexel teams and staff to ensure an appropriate level of understanding regarding sound epidemiologic (and risk management, where applicable) principlesServe as a senior-level scientific liaison to all functional service groups within Parexel (e.g., medical, biostatistics, pharmacovigilance, medical writing) to ensure Real-World Studies project deliverables 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.Thought leadershipDevelop industry network and identify potential new business opportunities through rainmaking activitiesActively participate in leading industry forums and regular Thought Leadership contributions eg presentations, articles, postersBusiness strategyContribute to the strategic development of the Epidemiology service line and to the development of highly competitive scientific and operational delivery models that optimize both internal and external validityProvide input to Parexel’s Real-World Data strategyQualificationsSkills:Driven to deliver high-quality results on time and in a highly ethical and professional mannerStrong interpersonal skills and the ability to quickly build and sustain positive relationships with customers and internal teamsIn-depth knowledge of the role of Epidemiology across the biopharmaceutical and medical-device product lifecycleDemonstrated ability to strategically apply Epidemiology knowledge 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 presentationsDemonstrated ability to communicate complex ideas in a simple, understandable and compelling manner Demonstrated skill in a consultative selling and project-delivery environmentHighly effective communication skills, both written and verbal, at all levels with customers, internally and with the industry at largeDemonstrated ability to direct and mentor study teams, work in a matrix environment and value the importance of teamworkComfortable operating in a demanding, fast-paced environment and capable of reacting swiftly to changing business demandsDemonstrated ability to digest information, assess it critically and provide thoughtful interpretations and guidance in meeting settings with customers and teams. Knowledge and Experience:10+ years’ Epidemiology 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 (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 designsRemains current with regulatory and other industry positions on epidemiologic approaches and real-world evidenceRequires consulting experience where the candidate added clear value to epidemiologic study design and/or provided an innovative solution to Sponsor’s business needs in real-world evidence generation and/or drug safetyDemonstrated Thought Leadership and name recognition through published works and industry / scientific presentationsComprehensive knowledge of global regulations regarding pharmacovigilance, risk management and safety reporting; drug development; epidemiologic / non-interventional research methodologies; and pharmacoepidemiologic statistical-analysis modelsExperience working with Academic Institutions or Healthcare Providers a plusEducation:

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

Travel:

This role requires up to 30% travel time (Europe and overseas).