Research Scientist, Clinical Outcome Assessment

Work Schedule

Environmental Conditions

Job Description

Overview:

ThermoFisher Scientifics 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.

Essential Functions

Projects

• 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 quantiative 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

Teamwork and Quality

• 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

Organizational Contributions

• 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

Qualifications:

Education and Experience:

• PhD in relevant scientific discipline
• or masters degree and at least five years of experience in relevant field
• or bachelors degree in a relevant scientific discipline and at least seven years of experience in relevant field

Knowledge Skills and Abilities:

• 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
• Experience in the analysis of qualitative and quantitative data desirable

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• 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 and 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

For more information on our benefits please visit: Experience:

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