Principal Scientist, Signals Strategy & Informatics Lead

Job Description We are a global biopharmaceutical leader with a varied portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to inspire our employees as we learn, develop and grow in our careers. We are proud of our over 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development. We are seeking a Principal Scientist, Signals Strategy & Informatics Lead to join our Digital Insights (DI) team within the Development Sciences and Clinical Supply (DSCS) Digital Technologies organization (DDT). Digital is the multiplier that will allow DSCS to deliver better experiments faster, efficient filing and launch, more robust supply chains and higher-confidence decisions across the portfolio. The DSCS Digital Technologies organization is responsible for the invention and application of new digital tools/workflows to support scientists across drug substance development, drug product development and analytical development. We aspire to embed digital technologies into the fabric of DSCS culture to drive transformational impact across the CMC space. In this role, the Principal Scientist will provide business ownership and scientific leadership for Signals, including its strategy, product roadmap, software development life cycle (SDLC), adoption, and sustained value delivery. The role will connect scientific business needs, digital product delivery, and informatics capabilities to ensure Signals is a trusted platform for structured data capture, method and process/product performance monitoring, predictive analytics, and prospective modeling. The successful candidate will lead Signals as a strategic scientific and digital capability across DSCS and in partnership with our Discovery and Manufacturing organizations. Responsibilities will include defining and executing the Signals strategy; partnering to establishing Signals data governance, prioritization, and releases through the SDLC; partnering with product, technology, scientific, and quality stakeholders; and advancing informatics solutions that convert structured Signals data into actionable insight. In addition to this role being the primary point of contact for Signals business ownership, the role will establish approaches for monitoring analytical methods, assay performance, product & process trending, performance monitoring, identifying trends and emerging risks, and developing prospective models that support more confident and timely scientific decisions. The role demands strong scientific and informatics leadership, technical supervision of Signals adjacent colleagues, organizational influence, product ownership discipline, and the ability to translate business needs into scalable digital capabilities across CMC development. Primary Responsibilities Champion the vision for a modern, data-rich DSCS by evolving Signals Notebook from an initial data repository platform into an integrated, automated data hub. Serve as the business owner and scientific lead for Signals, accountable for capability vision, value delivery, adoption, and alignment with DSCS priorities; coordinate activities with other functional areas utilizing Signals. Define and execute the Signals strategy and multi-year roadmap in partnership with Digital Insights, DDT, scientific functions, GxP-facing teams, Quality, and Enterprise Information Technology teams. Own the Signals software development life cycle, including demand intake, requirements gathering, prioritization, release planning, testing, deployment, lifecycle management, and continuous improvement. Establish transparent governance, decision rights, stage gates, and success measures for Signals enhancements and new use cases. Translate scientific and business needs into clear product requirements, user stories, acceptance criteria, and scalable informatics solutions. Lead the Signals informatics strategy for the use of structured data across drug substance, drug product, and analytical development workflows. Develop and deploy predictive analytics capabilities, such as method performance monitoring and product trending, to identify trends, variability, method performance, emerging risks, and opportunities for intervention. Lead prospective modeling initiatives based on structured Signals data to improve prediction, planning, investigations, and scientific decision‑making. Partner with laboratory scientists, analytical leaders, data scientists, statisticians, software engineers, and digital product teams to design solutions that align with scientific workflows. Ensure Signals data and workflows support appropriate data quality, traceability, metadata management, governance, and data reuse for analytics and modeling. Define and monitor product, adoption, data quality, and business value metrics; leverage evidence and user feedback to guide roadmap decisions. Drive change management, stakeholder engagement, training, and community‑building efforts to expand effective use of Signals across DSCS. Partner with IT and enterprise data teams to align Signals architecture, integrations, security, support, and lifecycle practices with corporate standards. Communicate scientific, product, and technical concepts effectively to both technical and non‑technical audiences. Influence strategic decisions through data‑driven recommendations, roadmap planning, and cross‑functional leadership. Required Qualifications Education Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a closely related field, with a minimum of six (6) years of industrial, pharmaceutical, or other relevant experience. Master’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a closely related field, with a minimum of eight (8) years of industrial, pharmaceutical, or other relevant experience. Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a closely related field, with a minimum of ten (10) years of industrial, pharmaceutical, or other relevant experience. Experience Relevant experience in the pharmaceutical, biotechnology, life sciences, or healthcare industry, with demonstrated impact in analytical development, laboratory informatics, scientific data management, or a related discipline. Recognized subject matter expertise with a proven track record of scientific contribution, innovation, and problem‑solving in analytical sciences, scientific informatics, data science, or digital product development. Demonstrated ability to independently lead complex, multidisciplinary scientific or digital initiatives from strategy and concept through implementation, adoption, and measurable value realization. Experience serving as a scientific lead, business owner, product owner, or capability lead for an enterprise digital platform, laboratory informatics product, or scientific data capability. Demonstrated experience defining scientific or product strategy, establishing multi‑year roadmaps, setting priorities, and making risk‑based decisions within a complex stakeholder environment. Strong understanding of software development life cycle (SDLC) practices, including requirements definition, prioritization, testing, release management, change control, adoption, support, and continuous improvement. Deep knowledge of structured pharmaceutical data, laboratory informatics systems, scientific data standards, metadata, data quality, traceability, and the use of governed data for analytics and modeling. Demonstrated experience designing, applying, or providing scientific oversight for analytical performance monitoring, statistical trending, multivariate analysis, or related approaches used to evaluate method and assay performance. Experience developing, deploying, validating, or governing predictive and prospective models based on structured scientific data. Ability to identify high‑value scientific opportunities and translate complex workflows and business requirements into product requirements, scalable informatics solutions, and measurable outcomes. Proven ability to influence without direct authority, provide technical and scientific leadership to matrixed teams, mentor colleagues, and build alignment across scientific, digital, technology, quality, and business stakeholders. Excellent written and verbal communication skills, including the ability to communicate strategy, scientific rationale, risks, and recommendations to senior leaders and both technical and non‑technical audiences. Demonstrated ability to establish new ways of working in emerging or undefined areas, including developing best practices for predictive analytics and informatics solutions that help expand adoption of new technologies. Required Skills CMC Development, Data Analysis, Data Science, Innovative Thinking, Leadership Mentoring, Predictive Analytics, Product Management Strategy, Product Requirements, Scientific Modeling, Scientific Presentations, Software Development, Software Development Life Cycle (SDLC), Strategic Thinking, Value Realization Preferred Skills Informatics, Pharmaceutical Industry US And Puerto Rico Residents Only Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Requirements As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation Domestic VISA Sponsorship Yes Travel Requirements 10% Flexible Work Arrangements Hybrid Shift Not Indicated Valid Driving License No Hazardous Material(s) n/a Job Posting End Date 11/12/2026 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID

R424375