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

Required Experience and Skills:

• Minimum of 5 years of experience in industry

• 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:

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

• 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

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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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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

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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.

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Requisition ID:R341186