Research Scientist, Clinical Outcome Assessment

Thermo Fisher Scientific•Waltham, MA

1d•Onsite

About The Position

ThermoFisher Scientific’s Patient-Centered Research (PCR) group helps sponsors to consider the patient voice in all relevant healthcare decisions, from development over regulatory to reimbursement and product launch. For that, PCR uses a unique combination of scientific fields, including health sciences, psychometrics, epidemiology, psychology, health economics and others. Our work has helped identify and clarify unmet clinical needs, assess burden of illness and evaluate patient outcomes, preference and/or adherence, while supporting promotional and labeling claims on a global scale. The advertised role will contribute to this research agenda and help ensure the patient voice is heard. The Research Scientist will lead the response to client requests and serve as Principal Investigator (PI) for Clinical Outcome Assessment (COA) strategy and research, including qualitative and quantitative studies to support instrument development, content validity, psychometric validation, and application. Responding to RFPs involves consulting with the study sponsor on their need, providing strategic advice on the study design to meet these needs and leading the development of a high-quality proposal. As PI the role provides end-to-end leadership of the awarded research activities, including study design, protocol development, execution, data analysis, reporting, and dissemination of high-quality research. The Research Scientist will work closely with Research Associates, who provide support across study execution, data collection, and analysis. The role will provide scientific guidance and direction to ensure high-quality outputs and efficient study delivery. The role also requires close collaboration with cross-functional teams, including the Project Management Office, Editorial Services, and Data Collection Management & Analysis, to ensure studies are delivered on time, within scope, and to the highest quality standards. This is a client-facing position, requiring strong communication and partnership with study sponsors across a range of applications. The Research Scientist will ensure scientific rigor, align research activities with client objectives, and contribute to innovative study design and execution. The successful candidate will bring strong scientific leadership, project ownership, and the ability to manage multiple studies in a fast-paced environment. This role offers the opportunity to further develop leadership capabilities, deepen subject matter expertise, and contribute to the strategic growth and impact of the organization.

Requirements

PhD in relevant scientific discipline or master’s degree and at least five years of experience in relevant field or bachelor’s degree in a relevant scientific discipline and at least seven years of experience in relevant field
Demonstrated expertise in COA strategy, including instrument selection, development, validation, and regulatory application
Demonstrated ability to lead and oversee qualitative and quantitative analyses, including development of analysis plans, interpretation of complex datasets, and integration of mixed-methods evidence to support COA strategy and regulatory objectives
Strong expertise in psychometric and statistical methods applied to COA research, with the ability to design, interpret, and critically evaluate quantitative analyses
Demonstrates strong analytical and problem-solving skills
Excellent written and oral communication skills: scientific, professional, and consulting
Demonstrates ability to independently manage, oversee, and/or lead a variety of project-related tasks and effectively delegates tasks to project team
Demonstrates ability to manage client relationships
Collaborative team member, capable of efficient multi-tasking
Ability to develop positive, collegial, and productive relationships with colleagues and clients
Proficient in the use of MS Word, PowerPoint, and Excel

Nice To Haves

Experience in the analysis of qualitative and quantitative data desirable

Responsibilities

Lead the development of study designs, budgets, and proposals as Principal Investigator, with full accountability for scientific and operational delivery, encompassing mixed-methods research integrating qualitative and quantitative (psychometric) approaches
Review and approve all deliverables for client review (e.g., protocols, qualitative and quantitative research reports, qualitative and statistical analysis plans, and regulatory briefing documents)
Effectively lead Research Associates and junior staff throughout projects
Communicate with internal and external partners (e.g., vendors, patient advocacy groups, other departments)
Lead the selection, development, and validation of COAs, including PROs, ClinROs, ObsROs, and PerfOs, in line with regulatory and scientific best practices.
Oversee data analysis strategy and ensure data quality control standards are met, including qualitative coding frameworks and psychometric evaluation (e.g., reliability, validity, responsiveness)
Lead scientific dissemination, where applicable (incl., manuscripts, posters, oral presentations at conferences)
Ensure accurate and timely recording of project time on a weekly basis
Contribute to strategic initiatives and/or research projects, depending on capacity and priorities
Complete relevant training courses on time (e.g., adverse event training, SOPs, ethics)
Efficiently direct, delegate, and communicate with project teams
Provide scientific support and on-the-job guidance to research associates and junior project team members particularly in COA methodology, qualitative interviewing, and regulatory expectations
Work with the study team and Project Management Office to track and drive the project timelines and budget use
Be familiar with electronic and paper filing requirements, relevant SOPs and IRB needs
Communicate effectively internally and externally with clients including providing strategic guidance on COA selection, development pathways, and regulatory positioning
Lead proposal development, delegate development, and contribute strategically to project bidding and study design.
Build and maintain long-lasting client relationships as a scientific lead
Stay up to date with research and integrate emerging insights into study design and delivery including regulatory guidance (e.g., FDA, EMA) and industry best practices related to COAs
Contribute to initiatives in the Patient-Centered Research (PCR) team (e.g., pillar initiatives, practical process improvements, contribution to training, serve as mentor), including advancing COA capabilities, tools, and methodologies within the organization
Actively participate in team meetings and organizational discussions, contributing scientific and strategic perspectives
May supervise junior staff

Benefits

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO)
10 paid holidays annually
Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
Accident and life insurance
Short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

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