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Vera Therapeutics, Inc. · 1 day ago

Director, Combination Product Development

Brisbane, CA

Full-time

Onsite

Director/Executive

$212K/yr - $270K/yr

10+ years exp

Vera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. The Director of Combination Product Development will lead the combination product development team, overseeing the regulatory strategy and execution of biologic/device combination products from concept to commercialization.

BiotechnologyHealth Care

Responsibilities

Propose, seek alignment across functions, and establish clinical and commercial drug/device product development strategy meeting US and ex-US regulatory guidance

Lead the combination product development team in design control, human factors, risk management, and DHF creation/maintenance

Lead the cross functional design control subteam

Collaborate with cross-functional teams, including product development, analytical, packaging, manufacturing, clinical development, supply chain, commercial, quality, and regulatory affairs, to ensure successful project milestone deliverables

Manage and prioritize multiple projects simultaneously, ensuring adherence to timelines and budgets

Ensure compliance with all relevant regulatory requirements, including FDA and EU regulations (e.g., EDDO, MDR) and ISO standards for combination products, throughout the product lifecycle

Author relevant sections for regulatory submissions (i.e., BLA, MAA, IND/IMPD) and for notified body opinions

Represent the combination product group with regulatory inspections and audits

Manage suppliers and contracts for the support of combination product development (i.e., device suppliers and test labs)

Qualification

Combination product developmentRegulatory strategyDesign controlRisk managementDrug delivery systemsHuman factors engineeringVendor managementCGMP process developmentAgile environment experienceCommunicationInterpersonal skills

Required

Bachelor's degree in biomedical engineering, mechanical engineering, pharmaceutical sciences, or related field

10+ years of experience in biologic-device combination product development, with a proven track record of successful product launches

Experience in the pharmaceutical industry is required

Extensive experience with the development and commercialization of prefilled syringes and autoinjectors

Proven experience in implementing and managing design control design verification/validation, risk management, and human factors

Deep understanding of subcutaneous drug delivery systems, systems engineering, materials, and manufacturing processes

Demonstrated knowledge of regulatory requirements and industry best practices, including in-depth knowledge of current FDA and EU combination product/medical device regulations and quality systems

Proven experience in vendor management and contract negotiation

Experience in cGMP process development, manufacturing controls, and process risk analysis

Excellent communication and interpersonal skills in working across the organization

Must be able to operate in an agile, fast-paced environment

Ability to operate in alignment with Vera's Core Values