Pliant Therapeutics is a clinical-stage biopharmaceutical company and leader in the discovery and development of novel integrin-based therapeutics. Based in South San Francisco, California, Pliant was founded in 2015 to develop therapeutics to modulate specific pathways upregulated or dysfunctional in certain diseases. Our approach involves developing novel integrin-based therapeutics to treat solid tumors and other diseases. Integrins are a crucial link between a cell's internal structure and its external environment and function in cell signaling, regulation and adhesion as well as wound healing and immune response.
Founded by a team of world-renowned researchers from the University of California, San Francisco, this group discovered key insights into the integrin biology and developed small molecule therapeutics to target this devastating disease process. Launched in 2016 by Third Rock Ventures, a leading healthcare venture capital firm, Pliant has developed an industry-leading proprietary library of over 15,000 integrins that serve as a key driver to its portfolio. We believe our platform may be broadly applicable across multiple disease areas including delivery of drug payloads to cells utilizing integrin receptor-binding molecules as tissue-specific delivery and internalization mechanisms. Currently, Pliant is conducting a Phase 1 study of PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that has shown encouraging clinical activity in the development of a treatment of immune checkpoint resistant solid tumors.
Description
The Senior Director, Regulatory Affairs will report to the Vice President, Regulatory & Compliance and is responsible for leading, developing and executing the global regulatory strategy for Pliant's oncology programs. This involves oversight for regulatory activities across the product lifecycle, from development through post-approval, while overseeing department activities and representing Regulatory Affairs in cross-functional teams. This highly visible and hands-on role will provide both strategic and operational support to regulatory activities across multiple therapeutic areas. This person will also lead interactions with the FDA and other regulatory agencies.
The Senior Director, Regulatory Affairs, must have strong strategic regulatory experience in oncology and be able to provide sound guidance, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. In addition, the Senior Director, Regulatory Affairs, will support an environment in which the team is highly motivated and engaged to work collaboratively within their team as well as cross functionally to deliver exceptional results and ensure long-term success.
(Remote* = Must be in our S.SF office 1X/mo. However, during onboarding period, you will be required to be onsite 2X/mo.)
• Responsibilities
• Lead the development and implementation of regulatory oncology strategies that result in successful registration and post-approval commercialization of products and product-candidates.
• Provide guidance to the cross functional teams based on technical and regulatory knowledge towards the development and implementation of strategic and tactical plans in alignment with corporate objectives.
• Proactively identify and assess regulatory risks associated with product development for Pliant's oncology program.
• Serve as the regulatory agency contact (e.g. FDA and other agencies) and in this capacity, fosters strong agency relationships while acting as a credible, reputable, and effective advocate for the company.
• Effectively lead meetings with Health Authorities to ensure full resolution of issues and opportunities.
• Lead all interactions/submissions to global Health Authorities including initial IND/CTAs, NDA/MAAs, supplements and variations, and any other key areas of discussions.
• Ensure the regulatory strategy is aligned with global Health Authority requirements and review documents for submission readiness to ensure that all submissions conform to relevant guidelines.
• Ensure that content in regulatory applications is complete, well-written, and meets all relevant requirements for the program's development phase.
• Support the product team in managing and directing regulatory inspections.
• Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
• Facilitate the strategies for the approval of products in rest-of-world regions either by the company or by its partners/affiliates, and act as the regulatory contact for ongoing alliance management activities.
• Partner with and support clinical development, CMC, medical affairs
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