Enable America Jobs

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 Senior Research Scientist (SRS), serves as the responsible person for strategic consultation, client insights and consultative selling, innovative solution development, defining best methods to address research needs, and partnering with research operations leadership to ensure flawless project execution. The SRS, will also be responsible for senior oversight of project design, protocol and final study report development, including delegating tasks to staff and ensuring the quality and timeliness of scientific deliverables. While the primary focus of this role will be on the pregnancy and lactation studies with a particular emphasis on safety, the SRS will also contribute to other study designs led by the ESA team.

Principal Duties and Responsibilities (Essential Functions):

• 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:

Scientific Strategy Consulting

• 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

Consulting Expectations

• 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.

Education, Professional Skills & Experience

• 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)

Benefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.