Distinguished Scientist, Companion Diagnostics

Job DescriptionThe Distinguished Scientist/ Executive Director within Companion Diagnostics (CDx) Development, will lead one of our company's Diagnostic Development Teams (DxDTs), supervising PhD-/MD-level employees, developing and overseeing CDx strategy development, alignment and execution for specific projects, including associated digital pathology (DP) projects when applicable. Position reports to Associate Vice President, Companion Diagnostics (CDx).Primary Responsibilities:Lead cross-functional DxDT including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, etc. to drive CDx strategy, development and implementation of CDx projects – and associated DP when relevant – for a portfolio of various assets/biomarkers, mainly in the therapeutic area of OncologySupervise PhD-/MD-level employees leading and executing diagnostic projects within CDx subteams and coordinating the work conducted with our external Dx partners, including associated DP efforts when neededPartner with internal stakeholders (e.g. clinical/asset teams, Biomarker Leads, CDx Regulatory, Commercial) to assess DxDT needs and develop strategies to address those needsContribute to the selection of appropriate assays, platforms and Dx partners for the execution of biomarker strategies, including overseeing possible design/execution of pilot studies with Dx vendorsIdentify and assess novel technologies/platforms with potential for CDx applicationOversee team preparation of Dx-related regulatory documents including, for example, pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs, and participation in meetings with global regulatory agencies to provide CDx expertiseOversee team members performing operational tasks required to execute assigned projects as needed, e.g. ordering samples, QC of incoming clinical trial biomarker results, assay/data transfer troubleshooting, etc.Serve as a subject matter expert within our company, collaborating with project teams, biomarkers, clinical operations, regulatory affairs, medical affairs and commercial on the implementation of global CDx assay strategies in global clinical trialsOversee internal project-level senior management and governance interactions relevant to CDxOversee DxDT input into preclinical and early-stage oncology programsProvide CDx expertise/assessment for due diligence teamsEducation Minimum Requirements: Ph.D. in an appropriate scientific discipline such as molecular biology, biochemistry, genetics, biomedical engineering, biophysical chemistry, etc.Required Experience and Skills:Minimum of 8 years of experience in industry settingExtensive experience with one or more major biomarker platforms (i.e. NGS, IHC, PCR)Knowledge of the discovery, development and application of biomarkers in support of decision making for drug development and as CDxDemonstrated track record in the development and approval of CDxDemonstrated expertise in diagnostic development as evident by peer review publication record, patents, and/or productsDemonstrated experience in developing and implementing strategic approaches across functional groups and in conjunction with global pharma teams Demonstrated experience in working with clinical teams to support design, implementation and analysis of clinical trials incorporating key biomarkers in order to yield data that can support CDx development and regulatory submissionsFamiliarity with requirements for EU IVDR, China HGRAC, Japan PMDA, and other global markets for CDx development/registrationProven decision-making and planning skillsHigh level of verbal and written communication skills including presentation capabilities to senior executivesPreferred Experience and Skills:Experience in both pharma and Dx settingsDeep technical knowledge in an area of focus such as circulating tumor DNA (ctDNA), immunohistochemistry/ pathology, digital pathology, etc.Experience directly interfacing in meetings and written documents with global health authoritiesRequired Skills: Analytical Thinking, Assay, Bioanalytical Techniques, Biomarker Development, Clinical Trials, Communication, Companion Diagnostics (CDx), Drug Development, Innovation, Leadership, Scientific Leadership, Strategic ForesightPreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS 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 RightsEEOC 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 ActsThe salary range for this role is$210,400.00 - $331,100.00This 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 .You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation:Domestic/InternationalVISA Sponsorship:YesTravel Requirements:10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:08/21/2026*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. SummaryLocation: USA - New Jersey - Rahway; USA - Massachusetts - Boston (MA Parcel B Laboratory); USA - Pennsylvania - Upper Gwynedd; USA - Pennsylvania - West PointType: Full time