Director, Combination Product Development

Role Summary

We are seeking a highly skilled and experienced Director to lead the combination product development team at Vera, reporting into the Sr. Director of Biologics Development. This critical role is responsible for the regulatory strategy, development, and execution of Vera’s biologic/device combination products from concept to commercialization. The ideal candidate will possess a deep understanding of drug delivery systems, design control, human factors engineering, risk management, combination product regulations, and a proven track record of successful product development. The candidate must have exceptional organizational, communication, and people skills, in addition to being capable of communicating strategic plans to leadership and project teams. 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

• 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).

Qualifications

• Bachelor’s degree in biomedical engineering, mechanical engineering, pharmaceutical sciences, or related field. Advanced degree preferred.
• 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. Experience with biological drug products and packaging development is a plus.
• 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. Start-up experience is a plus.
• Ability to operate in alignment with Vera’s Core Values.

Education

• Bachelor’s degree in biomedical engineering, mechanical engineering, pharmaceutical sciences, or related field. Advanced degree preferred.