Senior Principal Scientist/Senior Director Companion Diagnostics

Job Description

In this Senior Principal Scientist/Senior Director position in the Companion Diagnostic (CDx) Development Group, this team member will provide strategic leadership for CDx development and commercialization for a variety of programs, and oversee execution of those strategies in collaboration with the cross-functional CDx Teams, the Early Development Teams (EDTs), Asset Development Teams (ADTs), Product Development Teams (PDTs) and our diagnostic partners. Position reports to Executive Director, CDx Development.

 

Primary Responsibilities:

• Develop and direct CDx/IVD strategic approaches and lead CDx development projects spanning from preclinical through Phase 1-3 clinical trials and registration/launch

• Lead cross-functional CDx Teams for various assets/biomarkers including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, etc. to drive CDx strategy development and implementation of CDx projects

• Partner with internal stakeholders (e.g. ADTs, PDTs, EDTs, Biomarker Leads, CDx Regulatory, Commercial) to assess program needs and develop CDx strategies to address those needs

• Drive CDx partner/platform assessment and selection and provide leadership in Joint Project Teams with CDx partners to oversee execution

• Lead internal governance interactions relevant to CDx

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

• Responsible in conjunction with CDx Regulatory and other functions for CDx content for relevant regulatory documents including, for example, pre-submissions, briefing books, IDEs, PMAs

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

• Provide CDx input into preclinical and early-stage oncology programs

• Oversee transfer of assays from in-house efforts to Dx companies

• Provide CDx expertise/assessment for due diligence teams

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

Education Minimum Requirements: 

• PhD, MD or MD/PhD

Required Experience and Skills:

• Minimum of 7 years of experience in industry or academic setting

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

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

• Demonstrated experience in developing and implementing strategic approaches across diverse 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 molecular biomarkers in order to yield data that can support CDx development and regulatory submissions

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

Preferred Experience and Skills:

• Ten or more years' experience in industry, preferably in both pharma and Dx settings

• 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 focus such as circulating tumor DNA (ctDNA), immunohistochemistry / pathology, digital pathology

• Experience in development of digital pathology algorithms/assays

Required Skills:

Companion Diagnostics (CDx), Cross-Functional Teamwork, Diagnostics Development, Immunohistochemistry (IHC), Professional Networking, Strategic Leadership

Preferred Skills:

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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The salary range for this role is

$173,200.00 - $272,600.00

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:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/17/2026

*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.