Principal Scientist, Translational Clinical Biomarkers - Hematology/Oncology

Job Description We are seeking an accomplished and highly motivated Principal Scientist to provide strategic and scientific biomarker leadership across programs within the Oncology and Hematology portfolios. This role will lead the design, execution, analysis, and communication of translational and clinical biomarker strategies across programs spanning early through late clinical development. The successful candidate will develop decision-centric biomarker strategies that integrate therapeutic mechanism, tumor or disease biology, pharmacodynamics, molecular heterogeneity, patient selection, response and resistance, dose and regimen selection, and clinical endpoints. Biomarker plans should focus on generating high-value, interpretable evidence that informs program decisions rather than data generation alone. Key Responsibilities Develop and lead integrated biomarker strategies across oncology and hematology programs, in partnership with cross-functional development teams. Translate disease biology and therapeutic mechanism into clear translational hypotheses and fit-for-purpose biomarker approaches. Define how biomarkers can inform key development questions including proof of biology, target engagement, dose and regimen selection, patient selection, response assessment, resistance mechanisms, and go/no‑go decisions. Ensure biomarker strategies are focused and scalable, with clear linkage between the development question, proposed measurement, expected result, and potential action. Serve as the biomarker representative on cross‑functional program teams and provide strategic biomarker input to program-level decision making. Partner closely with Discovery, Clinical Development, Quantitative Sciences, Regulatory, Data Science, Clinical Operations, Pathology, Diagnostics, and other functions to develop integrated translational strategies. Lead interpretation of biomarker and clinical datasets and translate complex findings into clear, actionable recommendations. Develop approaches to characterize disease heterogeneity, molecular drivers, treatment response, mechanisms of resistance, and biological determinants of clinical outcome. Develop and evaluate patient‑selection and precision‑medicine strategies, including approaches based on genomic, transcriptomic, protein‑expression, cellular, or other disease‑specific biomarkers. Apply circulating and tissue‑based biomarker approaches, as appropriate, including ctDNA, minimal residual disease, molecular profiling, immunophenotyping, and pharmacodynamic biomarkers. For hematologic malignancies, develop strategies incorporating disease‑relevant measures such as molecular response, measurable residual disease, clonal evolution, mutational burden, lineage or cellular phenotype, and resistance‑associated alterations, as appropriate to the program. For solid tumors, develop strategies addressing target expression, tumor biology, molecular subtype, immune contexture, circulating biomarkers, mechanisms of response and resistance, and potential predictive biomarkers. Evaluate emerging biomarker technologies and analytical approaches based on their ability to address meaningful development questions and influence program decisions. Contribute to biomarker strategies supporting potential companion diagnostic or regulatory biomarker development, where appropriate. Communicate biomarker strategies, results, risks, and recommendations clearly to cross‑functional teams, governance groups, and key stakeholders. Provide scientific guidance and mentorship to biomarker scientists and contribute to a collaborative, strategically focused biomarker organization. Support publications, scientific presentations, external collaborations, and interactions with key external experts as appropriate. Qualifications Education Ph.D., M.D., or equivalent advanced scientific degree with relevant experience in oncology, hematology, translational medicine, biomarker science, drug development, or a related discipline. Required Experience and Skills Significant experience developing and executing translational or clinical biomarker strategies in oncology or hematology drug development. Strong scientific expertise in cancer biology, hematologic malignancies, translational oncology, or a related discipline. Demonstrated ability to translate scientific hypotheses into biomarker strategies that inform clinical development decisions. Strong understanding of the relationship between mechanism of action, disease biology, molecular heterogeneity, pharmacology, biomarkers, clinical endpoints, and development strategy. Experience with one or more relevant biomarker modalities, such as NGS, ctDNA, MRD, immunohistochemistry, flow cytometry, gene‑expression profiling, proteomics, or other molecular and cellular approaches. Ability to lead cross‑functional scientific work in a matrixed environment and influence without direct authority. Strong analytical and problem‑solving skills, including the ability to synthesize complex and multidimensional datasets into clear, decision‑oriented conclusions. Ability to prioritize high‑value, decision‑enabling biomarker work and distinguish it from lower‑priority exploratory activities. Excellent written and verbal communication skills and the ability to communicate scientific strategy to stakeholders. Working knowledge of biostatistics, bioinformatics, quantitative sciences, and multidimensional biomarker data analysis. Strategic mindset with a focus on scientific rigor, prioritization, scalability, and generation of actionable evidence. Preferred Experience and Skills Experience supporting oncology or hematology programs across multiple stages of clinical development. Experience with predictive, pharmacodynamic, prognostic, resistance, MRD, or precision‑medicine biomarker strategies. Experience integrating tissue, blood, molecular, and cellular biomarker data with clinical outcomes. Experience supporting biomarker strategies for targeted therapies, immune‑based therapies, antibody‑drug conjugates, cell therapies, bispecifics, or other novel therapeutic modalities. Familiarity with companion diagnostic development and associated regulatory considerations. Experience working across multiple programs or disease areas. Experience mentoring or providing scientific direction to other scientists. Required Skills Biomarkers, Clinical Development, Clinical Research, Ethical Compliance, Immuno‑Oncology, Mechanism of Action, Oncology, Patient Care, Pharmacodynamics, Protocol Development, Research Designs, Scientific Presentations, Scientific Writing, Strategic Thinking, Translational Medicine 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. Please click here if you need an accommodation during the application or hiring process. 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. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $190,800.00 - $300,300.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at . 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 No Travel Requirements 10% Flexible Work Arrangements Hybrid Shift 1st - Day Valid Driving License No Hazardous Material(s) N/A Job Posting End Date 10/9/2026 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: R417644 #J-18808-Ljbffr Merck & Co. Inc