Senior Manager, Drug Device Combination Product Development

$157,000 - $199,000/Yr

Vera Therapeutics - Brisbane, CA

Full-time - Mid Level

Brisbane, CA

Professional, Scientific, and Technical Services

About the position

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.

Responsibilities

• Develop and execute a strategic roadmap for biologic/device combination product development, aligning with the company's overall objectives.
• Collaborate with cross-functional teams, including product development, manufacturing, clinical development, supply chain, commercial, quality, and regulatory affairs, to ensure successful project delivery.
• Provide technical leadership and expertise in drug delivery technologies, device design, and manufacturing processes.
• Manage and prioritize multiple projects simultaneously, ensuring adherence to timelines and budgets.
• Manage vendor relationships and contracts for outsourced development and manufacturing activities.
• Ensure compliance with all relevant regulatory requirements, including FDA and EU regulations (e.g., MDR) for medical devices, throughout the product lifecycle.
• Lead the implementation and management of design control processes and facilitate maintenance of design history file.
• Lead human factors development activities to ensure usability and patient safety.
• Demonstrate expertise in prefilled syringe and autoinjector product development.
• Author relevant sections for regulatory submissions (i.e., IND, IMPD, BLA, MAA).
• Build and maintain strong relationships with key stakeholders, including internal and external partners.

Requirements

• Bachelor's degree in biomedical engineering, mechanical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred.
• 6+ years of experience in drug product device development, with a proven track record of successful product launches. Experience in the pharmaceutical or medical device industry preferred.
• Extensive experience with the development and commercialization of prefilled syringes and autoinjectors.
• Proven experience in implementing and managing design control processes.
• Deep understanding of subcutaneous drug delivery systems, materials, and manufacturing processes.
• Experience with biological drug products is a plus.
• In-depth knowledge of current FDA and EU medical device regulations and quality systems.
• Experience with human factors engineering and usability testing.
• Proven experience in vendor management and contract negotiation.
• Excellent communication and interpersonal skills in working across the organization.
• Ability to operate in alignment with Vera's Core Values.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401k match
• Flexible time off
• Paid holidays
• Annual performance incentive bonus
• New hire equity
• Ongoing performance-based equity