Associate Director / Director, Regulatory Affairs CMC
Harpoon Therapeutics is a clinical-stage immunotherapy company located in South San Francisco. Harpoon Therapeutics is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for small cell lung cancer and other DLL3-associated tumors. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. Harpoon has also developed a proprietary ProTriTAC™ platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. The company’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
Reporting into the VP/Head of Regulatory Affairs, the AD/Director of Regulatory CMC will be responsible for Regulatory CMC activities for the company’s current and upcoming investigational biological product(s). Key responsibilities for this position include developing regulatory CMC strategies to support the clinical development of the company’s investigational product(s), leading the preparation of CMC sections of regulatory submissions, interacting with global regulatory authorities, and providing relevant guidance to cross-functional teams to ensure that all applicable regulatory requirements are appropriately met. The AD/Director, Regulatory Affairs CMC, will also be responsible for ensuring product development compliance with global regulatory and quality standards.
- Develop global Regulatory CMC strategies for biologic products in early to late phase development to ensure acceptance, rapid review, and approval
- Identify the required CMC documentation for INDs, IMPDs, meeting packages, etc. and any content, quality and/or timelines issues for global submissions; negotiate the delivery of approved technical source documents in accordance with project timelines.
- Lead the development and review of high-quality CMC documentation for submission, applying global regulatory strategies and current regulatory guidelines.
- Serve as Regulatory Lead for CMC-focused FDA and EU Scientific Advice meetings, and the Regulatory point of contact for Contract Manufacturing Organizations and Qualified Persons.
- Support the CMC team by providing regulatory strategies for the development of the company’s novel therapeutics.
- Evaluate proposed manufacturing changes for global impact and provide strategic regulatory reporting strategies that support compliance change implementation
- Develop and maintain excellent relationships with the internal CMC functional, contract manufacturing organizations, and corporate partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory goals
- Represent the Regulatory Affairs CMC function on assigned cross-functional project teams
- Review and provide comments on SOPs, product container labeling, product specifications, comparability protocols and reports, quality agreements, pharmacy manuals, investigator brochures, and other related CMC documents
- Perform regulatory gap analysis of available CMC documents against regulatory requirements and plan appropriate remediation strategies.
- Monitor, interpret, and provide guidance to CMC teams minimally on ICH and EU CMC guidelines and keep current with changing regulatory requirements and expectations such as developments in guidance, regulations, practices and policies concerning CMC topics
- Contribute to the improvement, design and implementation of company regulatory processes and procedures where appropriate
Skills and Qualifications
- Bachelor’s degree (or equivalent) in life sciences, Masters or advanced degree preferred
- 10+ years of experience in the pharmaceutical industry, direct experience in regulatory affairs CMC or related function required
- Extensive experience in CMC aspects of biologic drug and analytical development, validation, and approval (INDs, BLAs, MAAs) across all phases of development in US and EU
- Direct experience leading End of Phase CMC-focused meetings with FDA required; experience with CMC elements of EU Scientific Meetings advantageous
- Ability to coach and mentor junior staff; prior experience with management of direct reports is desirable
- Strong understanding of GMP
- Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing
- Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority-setting to work effectively in a dynamic environment to meet aggressive timelines
- Self-motivated, self-disciplined, and able to function independently as well as part of a team
- Excellent computer proficiency (MS Word, Excel, PowerPoint, Visio, Adobe Acrobat, and document management systems); experience with Veeva RIM preferred
- Experience with eCTD requirements and electronic submissions
- Ability to work effectively across teams, functions and with outside partners.
- Excellent oral and written communication skills