Associate Director, Device Development

ABOUT THE ROLE

This is a key role within our Technical Operations team as we aggressively advance our two lead assets into mid- and late-stage clinical development. Both assets include a transition from vial to prefilled drug delivery devices with a subcutaneous route of administration.

The Associate Director, Device Development will be Marea’s technical lead for the device constituent of both programs, responsible for driving development of combination product configurations through Phase 3 clinical readiness and on toward the BLA and commercial readiness. The role owns device design controls end-to-end: user needs and design input requirements, risk management, design verification, human factors, and the device content of regulatory submissions. It also carries primary and secondary packaging development, container closure integrity, and shipping and distribution testing for both programs. The individual will work closely with the Drug Product, Analytical, Quality, Regulatory, Clinical Development, and Supply Chain teams and will direct the day-to-day technical work of Marea’s external combination product partners.

Marea operates a lean, outsourced model. External partners support combination product design and development, device platform supply, verification testing, and clinical assembly and packaging under Marea’s design controls. This role is Marea’s technical owner across all of them. We expect the candidate to be hands-on: writing and reviewing requirements, protocols, and reports; running technical reviews with partners; and working at partner sites during critical builds and studies.

This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.

KEY RESPONSIBILITIES

• Serve as Marea’s technical lead for combination product development of these programs, owning the design and development files for all product configurations
• Define user needs and design input requirements that integrate drug product attributes, such as viscosity, fill volume, and container closure, with device performance, and keep them traced through verification and validation
• Lead device risk management to ISO 14971:2019, including the use-related risk analysis, design FMEA, and process risk assessments with partners
• Plan and oversee design verification for Phase 3 clinical readiness to ISO 11608-1:2022 and program requirements: test method development and validation, statistically justified sample sizes and acceptance criteria, preconditioning and aging, and review of protocols and reports executed by partners and test laboratories
• Work with human factors specialists to plan formative and summative studies to IEC 62366-1:2015 and FDA human factors guidance, and carry the findings into design, labeling, and the instructions for use
• Direct the day-to-day technical work of external design and development partners, device constituent suppliers, and test laboratories, including statements of work, technical reviews, deliverable acceptance, and tracking against timeline and budget
• Support selection and technical oversight of the clinical assembly and packaging CMO, including design transfer, assembly process development, equipment qualification, and on-site support during clinical builds
• Lead primary and secondary packaging development, covering container closure integrity strategy and testing as well as shipping and distribution simulation testing
• Define the device portion of combination product stability and shelf-life studies with the Drug Product and Analytical teams
• Author and review device content for IND amendments, IMPDs, and the BLA and represent combination product development in meetings and correspondence with FDA and other health authorities
• Work with Quality on nonconformance, investigations, and CAPAs arising from development and clinical builds
• Plan and develop scope of work for external partners in alignment with internal CMC team and project team, work with the partners on execution and on-time delivery of the SOW scope.
• Travel to partner sites in the U.S. and abroad, approximately 10% of the time (with potential peaks during builds and critical studies.

QUALIFICATIONS

• B.S. in Mechanical, Biomedical, Chemical Engineering, or a related discipline with 10+ years of relevant experience, an M.S. with 8+ years, or a Ph.D. with 6+ years, in combination product or drug delivery device development in the biotech, pharmaceutical, or medical device industry
• Hands-on development of prefilled syringe and autoinjector combination products through design verification into Phase 3; BLA or NDA device experience strongly preferred
• Working command of design controls under 21 CFR Part 4 and 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019, IEC 62366-1:2015, and the ISO 11608 series
• Track record of directing external design firms, platform suppliers, test laboratories, and CMOs in an outsourced model, including scoping statements of work and holding partners to technical deliverables
• Demonstrated ability to write technical protocols, reports, and regulatory content, including statistically justified sample sizes and acceptance criteria
• Excellent written, oral, and interpersonal communication, especially with device partners and CMOs

PAY RANGE

The salary range for this role is $190,000-$220,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.