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The Senior Director (Clinical) 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. The Senior Director Epidemiology provides scientific guidance to Sponsors and internal project teams and play a key role in driving new business opportunities. In delivery, this role performs as oversight epidemiologist in projects, including in complex projects, taking accountability of supporting lead epidemiologist. May also perform as lead epidemiologist or as back-up, owning the development of deliverables and leads scientific contribution independently. Leads study-design workshops, as well as harmonizes scientific input to proposals from other contributors including, but not limited to, medical, biostatistics, COA science, and market access. 
 

The Senior Director Epidemiology leads Parexel’s contribution to industry forums and thought-leadership engagements to advance Parexel’s epidemiology services and market positioning. They develop and maintain a network of industry professionals and expand their sphere of influence within the industry. The Epidemiologist contributes to or leads selected parts of the strategic development of the Epidemiology service line. Provides input to the development of strategic and implementation plans for the department and contributes their expertise to the development of innovative and highly competitive project-delivery models.

Accountabilities and Supporting Activities

Epidemiologic deliverables

Oversee delivery of epidemiologic projects/deliverables, taking accountability of supporting lead and other epidemiologists. This includes supervising and overseeing the following work of the more junior epidemiologistsauthoring deliverables or selected parts of deliverables for Epidemiological Real-World Studies, including study protocols and study reports as well as orphan drug applications and diversity, equity and inclusion plansCollaboration with medical writers to complete deliverables, such as study protocols, study reports, manuscripts and conference contributionsReviewing and commenting on deliverables with Epidemiological content, including feasibility assessments, study protocols, CRFs, statistical analysis plans, data applications and data extraction documentation, analysis outputs, and study reportsCommunicating Epidemiological aspects of studies internally and externally, including in Sponsor meetingsAdvising on the selection of appropriate secondary-data sources, and epidemiology methods and analysesPerforming comprehensive literature reviews to inform the development and review of reports, including orphan drug applications, diversity, equity and inclusion plans, and risk management plans, as well as systematic/targeted literature reviews (without more senior guidance) May perform as lead epidemiologist or back-up on the above deliverables Develop and effectively communicate solutions to meet Sponsor’s Epidemiology and Real-World Study needs Independently lead development of project-specific study designs to meet Sponsors’ objectives, ensuring high-quality scientific expertise and approach, within the appropriate operational and commercial contexts (without more senior guidance) Contribute 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 platforms (without more senior guidance) Lead 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. Typically in collaboration with more junior epidemiologist.  May support in delivery of clinical trials, when epidemiological competence is of relevance, e.g. strategic feasibility, externally controlled trials, pragmatic trials
 

Business-development support

Effectively communicate Epidemiological considerations through written contribution to proposals, capabilities, client engagement, and presentation at bid meetings. Perform as epidemiology lead in proposals, independently, and provides oversight support to more junior epidemiologists in proposal work 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) May support in proposals of clinical trials, when epidemiological competence is of relevance, e.g. strategic feasibility, externally controlled trials, pragmatic trials
 

Cross-functional team support

Serve as a scientific mentor to Parexel teams and staff to ensure an appropriate level of understanding regarding sound epidemiologic (and risk management, where applicable) principles Serve 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 principles. 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

Develop and maintain collaborations and industry network and identify potential new business opportunities, as agreed with upper management Expand and lead Parexel’s contribution to leading industry forums and regular Thought Leadership contributions, e.g. presentations, articles, posters, as agreed with upper management
 

Business strategy

Contribute to or lead selected parts of 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 Support the business strategies of the other businesses at Parexel supported by Epidemiology, and reflecting that in design decisions and recommendations Provide input to Parexel’s Real-World Research (RWR) strategy
 

Skills:

Driven to deliver high-quality results on time and in a highly ethical and professional manner 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 across the biopharmaceutical and medical-device product lifecycle Demonstrated 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 presentations Demonstrated ability to communicate complex ideas in a simple, understandable and compelling manner Demonstrated skill in a consultative selling and project-delivery environment Highly effective communication skills, both written and verbal, at all levels with customers, internally and with the industry at large Demonstrated ability to direct and mentor study teams, work in a matrix environment and value the importance of teamwork Comfortable operating in a demanding, fast-paced environment and capable of reacting swiftly to changing business demands Demonstrated ability to digest information, assess it critically and provide thoughtful interpretations and guidance in meeting settings with customers and teams. 

Knowledge and Experience:

12+ years’ Epidemiology experience in academia, CROs, biopharmaceutical and/or medical-device industry setting(s), or elsewhere relevant to the position 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 single-cohort and comparative cohort studies, patient and physician surveys, cross-sectional studies). Remains current with evolution in industry on epidemiology methods, new and innovative study designs, and clinical data sources. Remains current with regulatory and other industry positions on epidemiologic approaches and real-world evidence Requires 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 safety Demonstrated Thought Leadership and name recognition through published works and industry / scientific presentations Comprehensive knowledge of global 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, MPH, PhD, DrPH) in epidemiology