Distinguished Scientist, Clinical Research

Merck; Upper Gwynedd Township (Montgomery County); Hybrid; USD 256,000 - 403,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Retirement benefits including 401(k)

Paid holidays and vacation

Job summary

Merck is seeking a Distinguished Scientist, Translational Clinical Biomarkers to lead a Biomarker Center of Excellence in oncology. You will supervise PhD-/MD-level scientists, develop end-to-end biomarker strategies from pre-FIH to Phase 3, and align translational plans with portfolio strategy in a multi-site environment.

Reporting to the Translational Clinical Biomarker head, you will drive hypothesis-driven research, collaborate with cross-functional teams, and contribute to regulatory

Qualifications

• Extensive experience in clinical trial development and translational biomarker work.
• Proven leadership in a matrixed, cross-functional environment.
• Strong publication record and biomedical research achievements.
• Deep knowledge of end-to-end biomarker and diagnostic development.

Responsibilities

• Oversee translational biomarker efforts across oncology clinical development programs.
• Lead PhD/MD-level scientists and develop end-to-end biomarker strategies.
• Collaborate with clinical, translational, informatics and diagnostic teams.
• Interface with health authorities and external collaborators; drive publication.

Skills

Biomarker strategy

Cross-functional leadership

Translational research

Clinical trial development

Data interpretation

Stakeholder communication

Matrixed team leadership

Education

PhD/MD with 15+ years oncology biomarker experience

Job description

Distinguished Scientist, Translational Clinical Biomarkers

The Distinguished Scientist/Executive Director within our Translational Clinical Biomarker team, will lead one of our company's Biomarker Centers of Excellence, supervising PhD-/MD-level scientists, developing and overseeing end-to-end biomarker strategy development, alignment and execution for multiple oncology therapeutic platforms, from pre-FIH to Phase 3 clinical studies and beyond. This New Jersey, Pennsylvania or Boston-based position reports to the head of the Translational Clinical Biomarker team.

Primary Responsibilities

• Oversight on cross-functional translational effort on key oncology therapeutic platforms.
• Oversight of translational biomarker efforts across clinical product development teams, in multiple indications.
• Lead a group of PhD-/MD-level scientists who are embedded in oncology clinical development programs.
• Hypothesis-building & definition of strategy: collaborate with stakeholders in clinical development team(s) and cross-functional translational teams, to formulate testable hypothesis and develop clinical biomarker and translational research strategy to test the hypothesis.
• Alignment, risk mitigation and strategy implementation with an enterprise mindset: align the development team strategy with broader portfolio strategy. Build critical scientific insights to identify gaps and risks, proactively develop mitigation plans. Work with matrixed stakeholders to ensure implementation.
• Collaborate with experimental experts, bio-informatics experts, statisticians and clinical stakeholders to build formal statistical analysis plans, analysis reports, and data communication plans. Participate in data analysis and interpretation.
• Effectively communicate the study plan, update and output across different function areas for optimal impact on projects.
• Collaborate with Asset Development Teams, Early Development Teams, Product Development Teams, Clinical Trial Teams, Discovery, Informatics, Diagnostics, quantitative modeling team, Biostats, Molecular Assay teams, and other key line functions to author protocol-specific biomarker plans and ensure their efficient implementation.
• Incorporate cutting edge scientific and technical advances to support clinical developments. Explore fit-for-purpose novel technologies/platforms to enable clinical biomarker analysis.
• Proactively identify and engage external KOL's on specific hypothesis-driven collaborations to complement internal effort. Drive the publication of biomarker and translational research for respective studies.
• Interface with translational and discovery laboratories to drive implementation of preclinical/translational projects based on emerging clinical/translational datasets.
• Incorporate cutting edge scientific and technical advances to support clinical developments. Form close partnership with clinical, BMx and companion diagnostics to ensure their efficient BMx implementation and seamless continuum to companion diagnostics.
• Contribute to Health Authority engagements, registrational efforts and Post Marketing Commitments.
• Provide Translational and biomarker expertise/assessment for due diligence teams

Education Minimum Requirements

PH.D. M.D or M.D./Ph.D. with a minimum of 15 years' experience in oncology biomarker studies and translational clinical research

Required Experience And Skills

• Must have extensive experience in clinical trial development and execution; clear strategic view on the translational needs in clinical studies; experience with experimental and bioinformatic aspects of translational research and biomarker development.
• Strong leadership skills in a matrixed team environment are essential. Proven track record in cross-functional, highly matrixed collaborative groups on drug discovery and/or clinical development.
• A proven track record in biomedical research, scientific scholarship and achievement;
• In-depth understanding of end-to-end drug and BMx/diagnostic development, with experience in biomarker discovery, biomarker and diagnostic development, and early or late drug development.
• Strong scientific expertise on translational and biomarkers over antibody-drug conjugates and T cell engagers. Deep scientific knowledge on cancer biology, and cancer immunology. Strong working knowledge of clinical oncology.
• Strong communication and analytical skills to regularly interface with broad stakeholders including senior leadership within the organization, as well as with external clinicians and scientists.
• Experience in communication with health authorities; experience with EU IVDR, China HGRAC, Japan PMDA, and other global markets for BMx and translational analyses strongly preferred.
• Prior direct management experience leading a team of PhD-/MD-level scientists with a demonstrated passion for and track record of talent development required
• Prior experience in drug discovery in oncology strongly preferred

Required Skills

Antibody Drug Conjugates (ADC), Biomarkers, Clinical Oncology, Clinical Studies, Clinical Trial Development, Diagnostics Development, Leadership, People Management, Strategic, Translational Research

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. Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is: USA - New Jersey - Rahway

The salary range for the primary location of this role is: $255,800.00 - $402,700.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

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 No

Travel Requirements 25%

Flexible Work Arrangements Hybrid

Shift 1st - Day

Valid Driving License No

Hazardous Material(s) n/a

Job Posting End Date 11/6/2026

• 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:R423522