Associate Vice President, Companion Diagnostics

The Associate Vice President (AVP) / Companion Diagnostics will be responsible for leading the diagnostics strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development. The successful candidate will have an essential strategic and tactical role in overseeing the scientific direction of companion diagnostics (CDx). Specifically, the Diagnostics Lead will develop and execute diagnostic strategies and interact with various stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development, ensuring timely delivery of CDx solutions for pharmaceutical registration and launch. This individual is expected to stay up to date regarding industry trends and diagnostic regulatory requirements.

Essential Job Requirements:

• Develop end-to-end diagnostic strategy in collaboration with key stakeholders and ensure alignment with clinical development strategies and timelines.
• Interact early with Discovery to understand the predictive hypotheses to be tested for specific programs and develop assays to reflect these hypotheses. Collaborate with internal research capabilities or external vendors to develop a predictive assay if not already available.
• Interact at all stages with Early Development and Late-Stage stakeholders to ensure strategic alignment.
• Conceive and develop CDx strategies for clinical development programs and obtain endorsement from various governance bodies.
• Oversee the CDx team, ensuring coordination of strategy and execution as well as career development of team members.
• Therapeutic focus will initially predominantly be in the Oncology Therapeutic Area, with a plan to expand into other therapeutic areas such as immunology, neurology, cardiometabolic and others as needed by the pipeline.
• Work with Regulatory Affairs to ensure that regulatory documents (e.g., IDEs, PMAs, etc.) are delivered and communicate with health authorities when required.
• Oversee the CDx development and ensure timely delivery of CDx solutions for pharmaceutical registration and launch.
• Communicate updates to, and seek feedback from, cross-functional stakeholders surrounding the progress of the CDx program.
• Stay up to date with industry trends, technology advancements, and regulatory requirements for diagnostic assays.
• Drive diagnostic product innovation and improvement through both in-house R&D efforts and in collaboration with diagnostic partners.
• Participate in other training, supervisory and management activities as required by the company.

Education:

• PhD required
• MD or MD/PhD is a plus

Other Qualifications:

• 10+ years of industry experience in clinical biomarker testing and CDx development.
• Deep understanding of scientific concepts, clinical development processes, clinical testing guidelines, and the regulatory requirements for diagnostic products and CDx.
• Ability to identify key information and make data driven decisions.
• Ability to use critical and strategical thinking to handle complex or ambiguous situations.
• Ability to articulate facts, ideas, and strategies in all communication formats.
• Ability to set and manage stakeholder expectations, ability to influence without authority.
• Ability to work effectively in a matrixed environment, ability to manage cross-functional teams.

Travel: up to 25 %

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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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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
$250,800.00 - $394,800.00

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 .

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 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:
Assay, Assay, Assay Development, Business, Cell-Based Assays, Clinical Development, Clinical Research, Communication, Conflict Resolution, Detail-Oriented, Ethical Compliance, Evaluating New Technologies, Exercises Judgment, Experimentation, Immunotherapy, Information Technology Trends, Laboratory Techniques, Management Process, Mentoring Staff, Neuroethics, Neurology, Neuroradiology, Patent Writing, Persuasion, Professional Networking {+ 5 more}

Preferred Skills:

Job Posting End Date:
08/16/2025
*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: R360065