Senior Director, Regulatory Affairs - Strategy/Advertising, Promotion and Labeling
Location
South San Francisco, CA | United States
Job description
Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.
The Company's lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the &alfa;vβ1 and &alfa;vβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b trial of bexotegrast for the treatment of IPF and INTEGRIS-PSC, a Phase 2a trial of bexotegrast for the treatment of PSC.
Pliant has also developed PLN-1474, a small molecule, selective inhibitor of &alfa;vß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of &alfa;vß8 and &alfa;vß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.
Description Reporting to the Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs - Strategy/Advertising, Promotion and Labeling, is responsible for will be responsible for the development and implementation of our global regulatory strategy. This involves providing regulatory oversight for regulatory activities across the product lifecycle, from development through post-approval, while overseeing department activities and cross-functional teams. This person will also support interactions with the FDA and other regulatory agencies. In addition, the person will be leading regulatory activities in regards to product labeling and advertising and promotion; including being the regulatory representative at Medical Legal and Regulatory (MLR) reviews, development of TPPs, and labeling.
To be successful in this role, you must be able to provide sound regulatory guidance, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. In addition, the successful candidate will support an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross functionally to deliver exceptional results and ensure long-term success.
Responsibilities - Leads the design and implementation of regulatory strategies that result in the successful registration and post-approval commercialization of products and product-candidates.
- Provides guidance to the cross functional teams based on technical and regulatory knowledge towards the development and implementation of strategic and tactical plans.
- Identifies and assess regulatory risks associated with product development across the programs.
- Helps to manages the external regulatory vendor and service team members and providers.
- Serve as the regulatory agency contact (at the FDA and at other agencies) by fostering strong relationships and acting as a credible, reputable, and effective advocate for the company.
- Effectively lead key meetings with Health Authorities to ensure full discussion of issues and opportunities.
- Act as the Regulatory representative in the cross-functional review of non-promotional material.
- Review and assess non-promotional materials for regulatory compliance with the applicable regulations and guidance documents.
- Evaluate and propose mitigations strategies for potential risks identified
- Share learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents with cross-functional team
- Develop best-practices and SOPs in regards to TPP/labeling
- Lead the development of regulatory TPPs (both early and late stage) and draft labeling (CDS and regional labels) for Pliant's pipeline molecules
- 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.
- Provide regulatory review and approval of product labeling, promotional claims, and advertising to ensure compliance with corporate policy, and US and international laws and regulations.
- Direct long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.
- Manage internal regulatory procedures to ensure compliance.
- May oversee and manage other regulatory functions, e.g. regulatory operations and regulatory writing.
Qualifications: - BA/BS Degree required in a health/life sciences or related field. Advanced degree preferred.
- A minimum of 12 years of regulatory affairs experience with 5 years of ad/promo and labeling experience.
- Direct and successful experience in Regulatory 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).
- Deep understanding of relevant US FDA regulations as well as international regulatory agencies (e.g. EU/EMA).
- Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment.
- Strong strategic skills including demonstrated ability to make complex decisions and willingness to defend difficult positions.
- Demonstrated excellence in project management with a proven track record of effectively managing multiple projects / priorities simultaneously.
- Experience serving as the company's regulatory liaison to the FDA's Advertising and Promotional Labeling Branch and Office of Prescription Drug Promotion
- Lead submissions of promotional material to FDA's Advertising and Promotional Labeling Branch and Office of Prescription Drug Promotion
- Regulatory representative in MLR reviews
- Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment.
- Strong strategic skills including demonstrated ability to make complex decisions and willingness to defend difficult positions.
- Demonstrated excellence in project management with a proven track record of effectively managing multiple projects / priorities simultaneously.
- Outstanding interpersonal / relationship-building skills, as well as influencing and negotiating 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.
- Excellent communication skills (written and verbal) in English.
Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).
The annual base salary for this role is $260,000 - $270,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant's compensation package also includes benefits, equity, and annual target bonus for fulltime positions.
To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit .
Job tags
Salary
