Associate Director, Combination Product Development Lead

Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide. When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies. Location: Boston, MA preferred Associate Director, Combination Product Development Lead We are seeking an Associate Director, Combination Product Development Lead to drive development of combination products. This role will have end-to-end accountability for the Design History File (DHF) and will play a central role in advancing device strategy, execution, and readiness for commercialization. You will operate at the intersection of device development, drug product, and external partner execution, with direct impact on product quality, program timelines, and patient experience. Roles and Responsibilities Combination Product Development: 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. DHF Ownership & Compliance: 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. Drug Product Considerations: 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. Risk Management & Usability: 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. External Partner Management: 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. Cross-functional Collaboration: 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. Program Management: 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 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. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Please visit our website at https://www.vorbio.com/ for more information.