Summary of Position:Scholar Rock is looking for an experienced Senior Director, Device Engineering to be the company's technical subject matter expert for combination products and drug delivery devices. This is a hands-on technical role, in which you will help shape and execute device engineering strategy for biologic assets, including the development of subcutaneous presentations using prefilled syringe (PFS) and autoinjector technologies, as well as drug delivery solutions for future pipeline assets.
You will lead key device development activities, including design controls, drug-device integration, assembly process development, characterization/validation, device risk analysis, design history file (DHF) management, verification and validation, design transfer and human factors engineering. You will also partner with Regulatory CMC on combination product regulatory activities and work closely with Drug Product Development, Drug Product External Manufacturing, Regulatory CMC, Quality Control, and Quality Assurance. This role includes the opportunity to lead external consultants and device partners and support oversight of device testing at contract test laboratories.
Position Responsibilities- Serve as Scholar Rock's technical lead and subject matter expert for combination products and drug delivery devices providing hands-on technical leadership across development programs.
- Lead device engineering activities that support prefilled syringe, needle safety system and autoinjector development programs.
- Provide technical leadership for drug-device integration, including primary container/device interfaces, syringe functionality, injection performance, dose delivery, and other critical device performance attributes.
- Define and maintain device user requirements, design inputs, design outputs, traceability matrices, verification/validation plans and acceptance criteria.
- Develop and maintain design history files (DHF), EU technical documentation files, design control documentation, risk assessments, and supporting technical documentation.
- Lead human factors engineering activities, including formative and summative usability studies.
- Partner with Regulatory Affairs and Regulatory CMC on U.S. combination product requirements and EU device requirements, including EU MDR Article 117 and Notified Body Opinion activities, as applicable.
- Provide technical leadership for device platform evaluation, selection, and lifecycle management activities.
- Partner with and oversee external consultants, human factors vendors, and device development partners.
- Develop scopes of work, manage budgets, and help ensure outsourced device-related activities are executed successfully.
- Support device-related investigations, change controls, commercial readiness activities, and post-approval lifecycle management.
- Establish fit-for-purpose device engineering processes and best practices as Scholar Rock's combination product portfolio grows.
- Foster a culture of scientific rigor, innovation, collaboration, and continuous improvement.
Candidate Requirements- A bachelor's degree in Engineering, Life Sciences, or a related discipline; an advanced degree is preferred.
- 15+ years of experience in combination product, drug delivery device, or medical device development for the US and EU; global experience is a plus, with significant technical leadership responsibility for combination products
- Knowledge of ISO medical device standards (11608, 11040, 10993, 13485, and 14971), FDA/EU guidelines, and global regulatory expectations for commercializing combination products, including FDA combination product requirements, 21 CFR Part 4, applicable Quality System requirements, and EU MDR Article 117.
- Experience with prefilled syringes, autoinjectors, and injectable drug delivery systems from project initiation through commercialization and post-approval lifecycle management.
- Experience with biologic drug-device integration, including primary container/device interfaces and functional performance of prefilled syringe systems.
- Hands-on experience with design controls, design history files (DHF), EU notified body technical documentation, risk management, design transfer, and verification and validation activities.
- Experience with commercially available autoinjector vendors and platforms (e.g., Ypsomed, SHL, or similar platforms) and demonstrated experience evaluating, selecting, and developing platform-based autoinjectors.
- Experience leading human factors engineering programs and usability studies, including development of human factors strategy
- Experience authoring and reviewing technical documentation supporting regulatory submissions.
- Strong leadership, communication, project management, and influencing skills, with experience working with external consultants, vendors, and technical service providers.
- The ability to work effectively in a highly collaborative, cross-functional environment and to balance strategic leadership with hands-on technical execution.
- Up to 20% travel as required.
Preferred Experience- Experience developing high-concentration biologics in prefilled syringe and/or autoinjector presentations.
- Experience taking at least one combination product through regulatory approval and commercial launch.
- Experience with biologics and combination product development globally, including the US, EU, and rest-of-world markets.
- Experience with both prefilled syringe and autoinjector presentations, including progression from healthcare-professional-administered to patient/caregiver-administered products.
- Experience supporting transition of products from intravenous to subcutaneous administration.
$245,000 - $325,000 a year
