Principal Scientist, Companion Diagnostics, Translational Oncology

Job Description

In this Principal Scientist/Director position within Translational Oncology, this team member will provide leadership for aligned and integrated development and commercialization strategies for diagnostics (Dx)/companion diagnostics (CDx), including associated digital pathology (DP) projects when applicable, and execution of those strategies in collaboration with Product Development Teams (PDTs), Asset Development Teams (ADTs) and our diagnostic partners. Position reports to Executive Director, CDx.

 

Primary Responsibilities:

• Direct CDx/IVD development projects, including associated DP efforts when needed, within Translational Oncology

• Lead cross-functional CDx (and where relevant, DP) development teams for various assets/biomarkers (including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, Alliance Management, etc.) to drive the implementation of Dx projects and coordinate the work conducted with our external Dx partners.

• Interface directly with scientists and physicians in discovery sciences, early-stage clinical development, and late-stage clinical development, as well as other PDT & ADT members, to craft the project team’s CDx (and associated DP if relevant) development strategy.

• Lead the selection of appropriate assays and Dx platforms for the execution of biomarker strategies.  

• Lead digital pathology efforts as needed for each individual CDx project

• Serve as a subject matter expert within our Company, collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global CDx assay strategies in global clinical trials.

• Participate in preparation of Dx-related regulatory documents including, for example, pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs.

• Participate in meetings with global regulatory agencies to provide CDx expertise.

• Provide CDx input into early-stage oncology programs.

• Assist in the transfer of assays from in-house efforts to in vitro Dx companies.

• Provide CDx expertise/assessment for due diligence teams.

• Evaluate relevant new technologies including possible design/execution of pilot studies with Dx vendors. 

• Perform 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.

 

Education Minimum Requirements: 

• MD/PhD, MD or PhD in Biology, Pathology, Oncology, Genetics/Genomics, Biochemistry, Chemistry, Biomedical Engineering, Bioengineering, Computer Science, Computational Biology, Biophysics, or related STEM field.

Required Experience and Skills:

• Minimum of 7+ years of experience in industry or academic setting, preferably in both pharma and Dx settings

• Extensive experience with one or more major molecular biomarker platforms (i.e. NGS, IHC, PCR)

• Knowledge of the discovery, development and application of molecular biomarkers in support of decision making for drug development and as CDx

• Demonstrated track record in the development of CDx

• Demonstrated expertise in molecular diagnostic development as evident by peer review publication record, patents, and/or products

• Experience influencing without direct authority, navigating complex or matrix organizations and successfully networking and forming partnerships with cross-functional teams.

• Proven decision-making and planning skills

• High level of verbal and written communication skills including presentation capabilities to senior executives

Preferred Experience and Skills:

• Experience in development of digital pathology algorithms/assays

• Experience with requirements for EU IVDR, China HGRAC, JPMA, and other global markets for CDx development/registration

• Experience directly interfacing in meetings and written documents with global health authorities

• Deep technical knowledge in an area of interest such as circulating tumor DNA (ctDNA), immunohistochemistry / pathology, digital pathology

#EligibleforERP

Required Skills:

Biomarker Assay Development, Clinical Development, Clinical Judgment, Clinical Medicine, Companion Diagnostics (CDx), Cross-Departmental Collaboration, Data Analysis, Diagnostics, Diagnostics Development, Drug Development, IVD, Mentoring Staff, Molecular Diagnostics, Project Reviews, Regulatory Affairs Compliance, Regulatory Experience, Research Proposal Development, Scientific Writing, Translational Oncology

Preferred Skills:

Digital Pathology, Global Regulatory

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

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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.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$156,900.00 - $247,000.00

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

You can apply for this role through https://jobs.merck.com/us/en (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 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:

04/2/2026

*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.