Senior Director, Program Management - Combination Products

Reporting to the VP of Program and Alliance Management, we are seeking a seasoned and results-oriented Executive/Senior Director of Combination Products Program Management to lead the development and commercialization of combination products integrating drug and device components. This role will provide strategic oversight and tactical leadership to ensure cross-functional alignment and successful program execution.

The ideal candidate will have a proven track record for bringing forward multiple drug-device combination products, and possess an understanding of the technical, quality and regulatory complexities involved. This role will require close collaboration across internal and external teams to drive operational excellence and may include oversight of one or more combination product programs.

Key Responsibilities

• Drive the day-to-day execution of combination product development from concept to commercialization ensuring delivery of milestones on time, within scope, and on budget, as aligned with company and program strategy
• Provide strategic leadership and tactical support for product development, design controls, and risk management
• Integrate cross-functional deliverables across including CMC, device engineering, regulatory, quality, clinical, nonclinical, and commercial functions, among both internal and external teams
• Develop and maintain comprehensive program plans, timelines, dashboards, and risk assessments to track progress and ensure proactive issue resolution
• In collaboration with functional leads, manage design history file generation, device master records, and combination product technical documentation, including failure mode effect analysis (FMEA), human factors studies and usability studies
• Ensure cross-functional alignment for compliance with relevant FDA and global health authority requirements, GxP regulations and ISO standards
• Partner with technical teams to execute on design control activities, including design inputs, outputs, verification, validation, human factors/usability studies, tech transfer and design history file maintenance
• Support regulatory submissions by contributing to dossier preparation, addressing health authority queries, and participating in audits related to devices
• Champion continuous improvement in program management practices and device technology strategies
  
  

Qualifications

• Advanced degree in Engineering, Life Sciences, or related field required (e.g., PhD, MS); PMP certification or equivalent preferred
• Minimum of 10 years of experience in a pharmaceutical, biotechnology, or medical device development company; at least 5 years managing cross-functional teams as a program manager
• Demonstrated success leading cross-functional combination product programs through product design and product registration
• Strong knowledge and understanding of quality and regulatory requirements for combination product development (e.g. 21 CFR part 820, ISO 13485, ISO 14971, IEC 62366, ISO 10993, MDR EU 2017/745)
• Exceptional leadership, communication, and stakeholder management skills with the ability to influence at all organizational levels
• High degree of flexibility and problem-solving ability, with a track record of innovative decision-making under pressure
• Salary is commensurate with experience
• Kiniksa Benefits Summary - USA
  
  

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.