Pliant Therapeutics is a public, clinical 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 disease. The Company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The Company’s lead product candidate, PLN-74809, is an oral, small molecule selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC), and are currently in Phase 2a clinical trials for these indications. Pliant’s second product candidate, PLN-1474, is an oral, small molecule selective inhibitor of the αvβ1 integrin, in development as a potential treatment for late-stage liver fibrosis under a partnership with Novartis. The Company also has discovery and development programs in oncology and muscular dystrophies. The Company is seeking passionate, creative, and dedicated individuals to join our team and contribute to our mission.

 

Description

 

Pliant Therapeutics, Inc. is seeking a Senior Counsel, Regulatory and Compliance who will help build and lead Pliant’s legal function. This is an on-site, Director level position, reporting to the General Counsel and Corporate Secretary. This position will be only the second attorney hire in a small but growing legal department and presents opportunities to grow with the company and have a strategic impact.

 

Responsibilities

 

  • Provide guidance and strategic counsel on relevant areas of US healthcare law and all applicable FDA regulatory laws, fraud and abuse laws, anti-bribery, Sunshine Act or price transparency laws product liability statutes and regulations.
  • Advise on information security matters and lead a third-party risk assessment program.
  • Build, administer and grow over time a stage-appropriate healthcare compliance program and FCPA compliance program.
  • Develop and provide organizational training as appropriate.
  • Work effectively with external counsel, wherever appropriate, and supervise their work.
  • Take on a variety of other matters depending on business needs

 

Qualifications

 

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

  • Working familiarity with at least some of the following relevant laws, regulations, guidance and industry codes including the FDCA, the federal anti-kickback statute, HIPAA, GDPR, U.S. PhRMA Code and OIG guidance and GxP principles.
  • Willingness and desire to develop other professional competencies, growing with the Company and working with outside counsel as necessary.
  • Help establish and grow a legal department and contribute to a positive work culture.
  • Excellent verbal and written communicator; delivers concise and clear advice that exhibits strong business judgment and ability to influence others.
  • In-house corporate legal and/or law firm experience that includes 5+ years of legal experience; and 3+ years of compliance and regulatory support relating to a biotech drug discovery and development. Other relevant experience, such as government and public service will also be considered.

 

 

 

To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/

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