Pliant Therapeutics

Senior Director, Regulatory Affairs – Oncology Strategy

Pliant Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: South San Francisco • California • United States

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Salary

💰 $270,000 - $300,000 per year

Job Level

Senior

About the role

  • 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, commercial and corporate activities, including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle.
  • Support the Pharmacovigilance and Safety functions as an active member of the Safety Governance and Review team.
  • Lead, manage, and develop a high performing team to support organizational growth as a late-stage clinical organization, including providing professional and personal growth opportunities, mentorship, and change management.
  • Provide the business development team with guidance and critical evaluation of potential product opportunities, in support of strategic partnering and licensing activities.
  • Support long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.
  • Help manage the external regulatory vendor and service team members and providers.
  • Manage internal regulatory procedures to ensure compliance.

Requirements

  • BA/BS Degree required in a health/life sciences or related field. Advanced degree preferred.
  • A minimum of 15 years in Regulatory Affairs, of which at least 8 years have been in oncology and at least 6 years of leadership experience managing a team.
  • Direct and successful experience in Regulatory activities including IND/CTA, NDA/BLA/MAA, lifecycle management, and developing and implementing complex regulatory strategies.
  • Proven experience leading interactions and negotiations with Health Authorities (US and ex-US preferred).
  • Strong understanding of relevant US FDA regulations as well as international regulatory agencies (e.g. EU/EMA).
  • Experience in the ability to deliver high quality regulatory submission documents.
  • Strong strategic skills including demonstrated ability to make complex decisions and willingness to defend difficult positions.
  • Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment.
  • Demonstrated excellence in project management with a proven track record of effectively managing multiple projects / priorities simultaneously. Demonstrated excellence in project management with a proven track record of effectively managing multiple projects / priorities simultaneously.
  • Exceptional written and oral communication skills.
  • Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
  • Managerial and personal development experience required.
Benefits
  • Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Regulatory AffairsIND/CTANDA/BLA/MAAlifecycle managementregulatory strategiesregulatory submission documentsproject managementregulatory complianceoncologyPharmacovigilance
Soft Skills
leadershipstrategic decision-makingcommunicationinterpersonal skillsconflict resolutionconsensus buildingmentorshipchange managementteam managementcross-functional collaboration
Certifications
BA/BS DegreeAdvanced degree in health/life sciences or related field