Principal Scientist - Early Program Monitoring, Device Product Assessment and Innovation

Job Description

Role Overview

The Principal Scientist (R5), Early Program Monitoring is responsible for leading early-phase and preclinical engagement for drug and drug–device combination candidates. This role guides drug delivery strategy from concept through development, aligning formulation characteristics—such as stability, viscosity, concentration, delivery volume, and excipient compatibility—with intended delivery models and use cases. The Principal Scientist partners with Discovery Pharmaceutical Sciences and serves as a primary interface across device, formulation, clinical, discovery, and Commercial/Marketing teams to enable coordinated planning, Device Target Product Profile creation, drug-device integrated timeline development, and timely, strategic iteration.

By integrating patient, provider, market access, and commercial insights, the Principal Scientist focuses development on the essential user needs & requirements, while minimizing program risk, including late-stage rework, for the device or drug-device combination product. The position drives structured assessments of drug delivery feasibility approaches & technologies, establishes the strategic and business rationale for delivery approach selection, and leads delivery-related inputs to product profiles and broader strategy, translating complex requirements into clear, actionable outcomes.

Key Responsibilities

Early Strategy and Portfolio Integration

• Lead early‑phase and pre‑clinical engagement for drug and drug–device combination candidates, guiding drug delivery strategy across route of administration, delivery approach, regimen feasibility, and device enablement from concept through transition to development teams.

• Partner closely with Discovery Pharmaceutical Sciences (DPS) to evaluate and align drug substance and drug product formulation characteristics (e.g., stability, viscosity, concentration, delivery volume, excipient compatibility) with intended delivery approaches and clinically relevant, use models.

• Collaborate with Human Health (Marketing and Commercial Strategy) to ensure early delivery and formulation decisions reflect patient, provider, market access, and commercial viability insights, focusing development efforts on what matters most and minimizing late‑stage rework. 

• Drive structured assessments of drug delivery feasibility, integrating formulation constraints, delivery route options, device‑ability, platform suitability, patient use considerations, and commercial trade‑offs into portfolio decision‑making.  Utilize structured approaches to ensuring comprehensive, cross-functional assessments are completed and aligned across the team.

• Serve as a primary interface across DPS, delivery, device, formulation, drug product, discovery, clinical, and Human Health organizations, enabling coordinated early planning and rapid feedback as formulation, delivery, and value propositions evolve.

• Establish and clearly communicate the strategic and business rationale for drug delivery strategy selection, including timing of formulation lock, device delivery decisions, drug-device development approach, resourcing assumptions, and lifecycle considerations, to support aligned governance outcomes.

 

Technology Evaluation and Execution

• Lead development and operationalization of delivery‑related inputs to the Device Target Product Profile (DTPP) and broader product strategy by translating DPS‑supported formulation attributes and Human Health‑informed use cases into clear, actionable delivery and device requirements.

• Guide alignment between formulation evolution, delivery system requirements, clinical development strategy and commercial intent, ensuring changes in strategy remain compatible with intended delivery technologies, patient experience, and market expectations.

• Advocate for early consideration of usability, human factors, dosing paradigms, administration environments, and value‑driving differentiated delivery attributes to ensure patient‑ and provider‑focused solutions with clear commercial relevance.

• Evaluate drug delivery technologies, platforms, and external solutions, including compatibility with formulation and clinical use models, IP considerations, freedom‑to‑operate, regulatory risk, and market access implications, in collaboration with DPS, Human Health, Legal, and Commercial teams.

• Assess competitive landscape and emerging drug delivery trends; challenge assumptions and recommend innovative approaches aligned with portfolio strategy and anticipated customer needs.

• Provide expert input to governance forums on drug delivery risk & mitigation strategies, opportunity, strategic fit, and downstream impact, helping teams avoid unnecessary churn and late‑stage misalignment.

• Develop high‑level, delivery‑enabled development strategies, transition plans, and timelines that support early commercialization readiness and long‑term lifecycle value.

• Influence and mentor cross‑functional teams through matrix leadership, fostering accountability, transparency, and collaborative problem‑solving.

• Contribute to continuous improvement of early program monitoring methodologies, tools, and decision frameworks as they relate to drug delivery, formulation–delivery alignment, and commercial relevance.

Qualifications & Experience

• 10+ years of experience in medical device development, drug–device combination products, and/or early‑stage program or portfolio leadership within pharma, biotech, or medical device organizations.

• Experience utilizing effective project management tools for managing risks & opportunities, as well as for communication of strategic decisions.

• Demonstrated success leading early‑phase, cross‑functional programs, including technology evaluation, portfolio strategy, and external collaboration.

• Strong understanding of medical device development, regulatory requirements, quality systems, and design controls, particularly as applied to combination products.

• Experience collaborating & communicating effectively with commercial, clinical, legal, and external partners to inform strategic decisions.

• Proven ability to lead, mentor, and influence global teams in complex, matrixed environments.

• Advanced degree in engineering, biomedical sciences, materials science, or a related discipline.

Required Skills:

Combination Products, Communication, Cross-Functional Communications, Detail-Oriented, Medical Devices, Program Monitoring, Vendor Relationship Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/5/2026

*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.