Senior Manager, Drug Device Combination Product Development

Title: Senior Manager, Drug Device Combination Product Development

Location: Brisbane, CA

About Us:

Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

Position Summary:

We are seeking a highly skilled and experienced Sr. Manager, Drug Device Combination Product Development to lead the device and combination product development activities at Vera. 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, be capable of communicating strategic plans to upper management, summarize data, and effectively manage 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.

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.

Qualifications:

• 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.

Vera Therapeutics Inc. is an equal-opportunity employer.

Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $157,000 - $199,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

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