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

Principal Scientist (R5), Early Program Monitoring

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

• 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

Salary Range:

$156,900.00 – $247,000.00