Associate Director, Combination Product Development Lead

Roles and Responsibilities

• Lead development of combination product systems from late-stage development through commercialization.
• Translate user needs into product requirements and executable development plans with defined milestones, risks, and timelines.
• Drive design verification and validation activities, including test strategy, execution, and documentation.
• Ensure alignment between device design, container closure systems, and fill–finish processes.
• Own and maintain the end-to-end Design History File / Design Development File (DHF/DDF) across device platforms, ensuring compliance and quality.
• Partner with Quality to support reviews, audits, and inspection readiness.
• Apply working knowledge of injectable drug product characteristics, including viscosity, injection forces, and dose delivery, to inform device design and performance.
• Anticipate and resolve device–drug product interaction challenges to ensure consistent and reliable delivery.
• Lead risk management activities, including hazard analysis and FMEA, and ensure risks are proactively identified and mitigated.
• Support human factors and usability efforts to ensure alignment with patient needs and intended use.
• Manage and coordinate development activities across external vendors and partners.
• Ensure deliverables meet technical, quality, and timeline expectations and are fully integrated into the DHF and overall development program.
• Support governance meetings and drive resolution of risks and dependencies.
• Partner across Supply Chain, Quality, Clinical, Commercial, Regulatory, and Manufacturing teams to align on priorities, timelines, and deliverables.
• Support regulatory submissions by ensuring device and combination product documentation is complete and consistent.
• Own program-level tracking of timelines, risks, decisions, and deliverables.
• Maintain plans and trackers in Smartsheet and communicate progress through clear timeline views using Office Timeline.
• Ensure documentation is controlled, accurate, and inspection-ready.

Skills and Competencies

• Combination Product Expertise: Strong understanding of combination product development, design controls, risk management, and verification and validation.
• Execution & Ownership: Ability to operate independently, manage complexity, and drive programs forward with clarity and accountability.
• Cross-functional Leadership: Proven ability to work across functions and align stakeholders in a fast-paced, matrixed environment.
• Problem Solving: Strong analytical and technical problem-solving skills, with the ability to anticipate risks and drive solutions.
• Communication: Clear and effective communicator, able to translate complex technical topics into actionable insights.

Education, Experience and Qualifications

• Bachelor’s degree in engineering or life sciences; advanced degree preferred
• 8–12+ years of experience in combination product, drug–device, or medical device development
• Demonstrated experience owning a Design History File / Design Development File (DHF/DDF) through development and commercialization
• Hands-on experience with parenteral injectors.
• Working knowledge of injectable drug product properties and their impact on device performance
• Experience managing external development and manufacturing partners in a regulated environment
• Strong organizational, program execution, and documentation management skills

Pay and Benefits

The salary range for the Associate Director, Combination Product Development Lead is expected to be between $170,000 and $195,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.

At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k).

From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond.