Senior Technical Program Manager, Product Dev

Position Summary

The Senior Technical Program Manager – Product Development is responsible for leading complex, cross-functional product development programs from concept through commercialization within a medical device and/or combination product organization using a stage-gate process. This role drives program strategy, planning, budgeting, execution, risk management, and delivery of key technical and business milestones across the product development lifecycle. In addition to managing device development programs, this position coordinates cross-functional activities supporting Investigational New Drug (IND) submissions and clinical program readiness, working closely with Regulatory Affairs, Quality Assurance, Medical Affairs, Clinical Operations, R&D, Engineering, Manufacturing, and other stakeholders.

Essential Duties & Responsibilities

Program Leadership and Pipeline Execution

• Lead assigned programs through feasibility, development, verification/validation, clinical development, regulatory submission, technology transfer, validation, and launch readiness, as applicable.
• Develop and maintain integrated plans, schedules, budgets, resource forecasts, critical paths, and key dependencies.
• Translate product, regulatory, and commercial strategies into clear cross-functional work plans.
• Lead core team meetings, clarify ownership and decisions, track actions, resolve barriers, and escalate risks with recommended options.
• Coordinate external laboratories, consultants, CROs, CMOs, and other development partners.
• Keep program execution aligned with approved business cases, portfolio priorities, and target milestones.

Development Process, Stage-Gate, and Design Control Ownership

• Author and maintain the Development Plan, program charter, stage-gate deliverable plan, governance calendar, and responsibility matrix.
• Plan and facilitate stage-gate and design reviews; prepare concise decision packages that summarize evidence, risks, resources, and recommendations.
• Track completion and quality of required development records, including applicable design and development files and medical device files.
• Coordinate traceability from user or patient needs and product requirements through verification, validation, risk controls, and transfer.
• Coordinate supplier qualification and development activities.
• Track supplier deliverables, samples, specifications, testing, and documentation.
• Initiate or coordinate change requests associated with projects.
• Track change-request activities (e.g., impact assessments) and implementation dates.
• Ensure key assumptions, decisions, changes, and deviations are documented through applicable development and quality processes.
• Partner with Quality and Regulatory Affairs to apply the development framework appropriately across BLA, device, combination product, and tissue-based programs to align delivery timeline.

Risk Management, CMC, and Development Strategy

• Lead the program risk process across technical, CMC, clinical, regulatory, quality, supply, and commercialization workstreams.
• Facilitate development and product risk assessments, including hazard analyses and FMEAs, as applicable.
• For BLA programs, integrate Quality by Design (QBD) principles from the starting material, raw material, process and analytical development, characterization, formulation, stability, comparability, control strategy, process validation, and manufacturing readiness activities into the program plan.
• Coordinate IND/BLA-enabling CMC deliverables and dependencies with nonclinical, clinical, Quality, Regulatory, and manufacturing teams.
• Track submission inputs, data availability, review cycles, validation readiness, and key regulatory commitments.
• Ensure critical risks and assumptions are addressed in development studies, protocols, acceptance criteria, control strategies, and program decisions.

Technical Deliverable Ownership

• Author or co-author selected deliverables consistent with the incumbent’s expertise, such as development plans, risk assessments, traceability matrices, protocols, reports, readiness assessments, and technology transfer plans.
• Lead selected technical workstreams, investigations, or structured problem-solving activities within the incumbent’s demonstrated area of expertise.
• Synthesize technical, scientific, quality, clinical, and regulatory information into clear recommendations and decisions.

Governance, Executive Communication, and Portfolio Support

• Prepare program dashboards, milestone forecasts, budget and resource summaries, risk updates, and decision logs.
• Support portfolio prioritization, resource planning, and pipeline scenario analysis.
• Translate leadership decisions into accountable actions and updated program plans.
• Promote consistent project management, stage-gate, documentation, and lessons-learned practices.

Skills & Abilities

• Strong knowledge of regulated product development, stage-gate governance, design controls, Quality by Design, risk management, verification/validation, technology transfer, and commercialization readiness.
• Working knowledge of biologics development and CMC expectations supporting IND/BLA programs.
• Ability to understand technical detail, challenge assumptions, and convert uncertainty into practical plans and decisions.
• Demonstrated ability to lead matrix teams and influence stakeholders without direct authority.
• Strong facilitation, executive communication, technical writing, negotiation, organization, and problem-solving skills.
• Proficiency with project scheduling, portfolio reporting, collaboration, and document management tools.

Position Expertise/Qualifications

• Bachelor's degree in Engineering, Biological Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, or a related technical discipline required; advanced degree preferred.
• 8+ years of experience in regulated product development, technical operations, CMC, engineering, or a related life sciences environment.
• 5+ years leading cross-functional product development projects or programs with responsibility for plans, risks, budgets, resources, and governance.
• Experience supporting biologics development and an IND, BLA, or major CMC submission program strongly preferred; medical device or combination product experience is advantageous.
• Knowledge of applicable FDA regulations (e.g., 21 CFR Part 820, 211, 212)) and guidances, ICH guidelines, cGMP requirements, and quality systems; knowledge of ISO 13485, ISO 14971, medical device design controls and Quality by Design required.
• PMP, PgMP, RAC, Lean Six Sigma, or similar certification preferred.