Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
Summary of Position:
Scholar Rock is seeking a highly motivated and innovative Associate Director to join our dynamic growing team. This role will provide oversight of combination product development with a keen focus on device development, including characterization testing, design verification testing and human factors/ usability engineering. The candidate will report to the Head of Drug Delivery Systems and collaborate closely with key internal and external stakeholders to revolutionize drug development and enhance patient lives through innovative dosage and drug delivery systems.
Position Responsibilities:
- Technical lead responsible for overseeing Design Control, Risk Management and Usability/Human Factors Engineering.
- Leverage comprehensive knowledge of relevant guidance, regulations, standards, and industry best practices in the design and development of medical devices and combination products.
- Lead technical efforts to evaluate appropriate device technologies by conducting exploratory research to gather user insights and design trends, translating user needs into product and system-level requirements and specifications.
- Provide expertise in use-safety engineering and usability risk management throughout the product development process, ensuring compliance with internal processes and external standards.
- Develop and maintain essential documentation, including Design and Development Plans, Design History Files, and Traceability Matrices. Actively participate in and drive Design Reviews, Design Control Boards, and Design Change controls.
- Onboard and manage vendors for Human Factors, User Research, and Visual Design. Develop Usability Engineering files in compliance with IEC and ISO standards.
- Design and execute Human Factors studies to evaluate product user interface- including hardware, software, packaging, instructional material, and training.
- Apply sound understanding of combination product regulatory requirements to compile CMC sections for IND/IMPD/BLA.
- Drive program execution excellence while ensuring efficient and timely escalation of urgent issues/risks to leadership.
- Develop and implement robust testing strategies to assess the performance, safety, and efficiency of combination products.
- Ensure compliance with relevant regulatory guidelines and standards (e.g., FDA, EMA) throughout the product development lifecycle.
- Stay abreast of emerging trends, technologies, and regulatory changes in the drug-device combination product field.
- Manage multiple projects simultaneously, ensuring timely delivery of milestones.
- Advanced degree (PhD, MEng, MS) in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline with 7+ years of relevant industry experience in device integration and development, combination product development, or advanced drug product development with a major pharmaceutical, biotechnological or a generic pharmaceutical company.
- Demonstrated experience in combination product development, including pre-filled syringes, pre-filled cartridges, auto-injectors, on-body devices, and novel devices for delivering complex formulations.
- Understanding of system thinking (drug+ primary container+ device+ software/app) and experience with human factors/ usability engineering.
- Experience with the development of connected devices is desirable but not required.
- Strong expertise in experimental design, statistical analysis, and data interpretation.
- Experience working within device standards: Design Controls (21CFR 820.30), Risk Management (ISO 14971); Quality Management (ISO 13485); Needle-based injection systems (ISO 11608-1); Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); EU Medical Device Requirements (EU MDR 2021); Medical Electrical Equipment (EN 60601) and related requirements ISO 11040, ISO 3951 and ISO 2859.
- Proven experience with IND/IMPD/BLA filings and maintaining Design History Files for combination products.
- Strong analytical and problem-solving skills, with the ability to think creatively and innovatively.
- Excellent communication and interpersonal skills, with the ability to work effectively in a multidisciplinary team environment.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.