Vera Therapeutics - Brisbane, CA
posted about 2 months ago
Vera Therapeutics is seeking a highly skilled and experienced Senior Manager for Drug Device Combination Product Development to lead the device and combination product development activities. This critical role is responsible for the overall strategy, development, and execution of biologic/device combination product projects from concept to commercialization. The ideal candidate will possess a deep understanding of drug delivery systems, medical device regulations, and a proven track record of successful product development. The candidate must have exceptional organizational, communication, and people skills, capable of communicating strategic plans to upper management, summarizing data, and effectively managing interactions with stakeholders across functions. This role involves collaborating with cross-functional teams to ensure that the combination products meet regulatory standards and are safe and effective for patient use. The Senior Manager will develop and execute a strategic roadmap for biologic/device combination product development, aligning with the company's overall objectives. This includes collaborating with product development, manufacturing, clinical development, supply chain, commercial, quality, and regulatory affairs teams to ensure successful project delivery. The role also requires providing technical leadership and expertise in drug delivery technologies, device design, and manufacturing processes, while managing and prioritizing multiple projects simultaneously to ensure adherence to timelines and budgets. Additionally, the Senior Manager will manage vendor relationships and contracts for outsourced development and manufacturing activities, ensuring compliance with all relevant regulatory requirements, including FDA and EU regulations for medical devices throughout the product lifecycle. The position also involves leading the implementation and management of design control processes, facilitating the maintenance of design history files, and leading human factors development activities to ensure usability and patient safety. The candidate will demonstrate expertise in prefilled syringe and autoinjector product development and will be responsible for authoring relevant sections for regulatory submissions such as IND, IMPD, BLA, and MAA. Building and maintaining strong relationships with key stakeholders, including internal and external partners, is also a crucial aspect of this role.