Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

• The SRS bears responsibility for scientific strategy for RWE, medical affairs, and certain clinical studies, including the leading of the overall research strategy development for proposals, the design and implementation of de novo data collection and diversified data design studies, as well as internal and external thought leadership. In particular, the SRS will:

• Be the responsible person for early client-facing interactions and development of strategies to maximize the potential for winning project work related to pregnancy and lactation studies through scientific consulting.
• Understand the regulatory context for RWE specifically related to pregnancy and lactation studies in key geographies and be able to advise clients to pursue the most plausible RWE strategies.
• Maintain current and in-depth understanding of the overall RWE landscape and provide leadership with ongoing recommendations for positioning the team and offerings.
• Collaborate on the development of innovative RWE solution-focused offerings
• Senior scientific oversight of studies.
• Be the responsible person for the design and implementation of selected.
• RWE/non-interventional study methods, conceptualize advanced study designs and develop/oversee the development of study protocols and statistical analysis plans and study reports; focus will primarily be on the pregnancy and lactation studies with a particular emphasis on safety, but will also provide scientific oversight on other study designs.
• Be responsible for the quality on-time completion of scientific deliverables; ensure study findings are valid and reliable.
• Responsible for final budget, deliverable and project timelines; identify scope expansion and need for amendments, as needed.
• Oversee and delegate tasks to mid-level staff.
• Internal thought leadership.
• Serve as consultant to other principal investigators or staff on other projects.
• Contribute to/lead growth in your area of responsibility.
• Serve as a subject matter expert in RWE, medical affairs, and epidemiology or biostatistics to the broader PPD organization.
• Mentor mid-level and junior staff.
• External thought leadership.
• Contribute to abstracts and manuscripts as co-author and when possible, first/senior author positions.
• Make presentations at scientific meetings.
• Contribute to Evidera's position as a recognized leader in RWE generation and integration.
• Contribute to the development and manage externally facing multi-stakeholder engagements.
• Business development
• Direct other "non-billable" activities, e.g. participate in proposals, design conceptual approaches for proposals, supervise mid-level staff, contribute to business development, identify and pursue business opportunities within Evidera and bring in new projects
• Travel (national and international) is expected

• Participates in client calls; addresses questions posed directly to him/her about his/her work.
• Responsible for scientific consultation and for use of best scientific methods to address research needs.
• Contributes to strategic thinking and innovation.

• PhD in Epidemiology, Masters in Epidemiology is required with at least 15 years' relevant expertise and experience in at least one (and preferably more) of the following key areas:
• Pregnancy experience is required
• Post-marketing experience
• Safety experience
• Medical affairs
• Clinical development in biopharma/biotech (especially peri- or post-approval late phase interventional studies)
• Medical device development (in-vitro diagnostics, SaaMD)
• Post-authorization drug/device safety, effectiveness, long-term follow-up
• HEOR/epidemiology/RWE
• 8+ years' management experience
• Knowledge of drug development process/familiarity with international regulatory requirements for drugs and devices in both pre- and post-authorization context
• In depth expertise on regulatory requirements for pregnancy and lactation studies
• In depth expertise and engagement in current global discourse around regulatory use of RWE is highly desirable
• Excellent understanding of core epidemiological study methodology and/or biostatistics
• Broad experience in quantitative methods in life-sciences research, focus on design and implementation of non-interventional and/or interventional studies
• Working knowledge of MS Office software; ability to read and understand SAS/STATA output; working knowledge of statistical analysis software (e.g., SAS, Stata, R) is a plus
• Analyzes complex issues and evidence, identify cause-effect relationships, and generate effective solutions
• Experience presenting ideas to individuals and groups in a formal presentation setting
• Tailors and delivers high-level presentations to diverse audiences using a variety of communication delivery methods (e.g., written, electronic, oral, interpersonal)