Senior Manager, Regulatory Affairs
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. The company recently reported positive data from its Phase 2a trial in IPF and is currently ramping up activities in preparation for a late-stage clinical trial at worldwide sites.
Pliant has also developed PLN-1474, a small molecule, selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant is initiating a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. 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.
Pliant is seeking an accomplished, creative, and dedicated regulatory professional to contribute to the Company’s mission of helping patients with life-threatening fibrotic diseases. The position will report to a Director of Regulatory Affairs and will support the regulatory activities for Pliant’s development programs. This includes supporting the strategic and operational activities for molecules from pre-clinical to clinical all the way to marketing applications.
- Lead activities in support of development and submission of regulatory dossiers as required to support global clinical trials, including initial INDs/IND amendments, CTA’s, IMPDs, annual reports, etc.
- Regulatory representative on internal clinical study teams and external CRO, review of clinical trial documents (protocols, ICF, investigator package).
- Support Regulatory Authority interactions and the preparations of meeting request and briefing document content.
- Support the strategy development, preparation and submission of global regulatory applications e.g. ODDs, PIPs.
- Participate in study and development teams and provide regulatory guidance as needed.
- Establish, manage, and maintain knowledge of current and emerging regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to cross-functional teams.
- Assure compliance with regulatory standards and guidance documents.
- Conduct regulatory risk assessments on issues that arise in development teams.
- Lead or support the generation or revision of SOPs related to regulatory affairs.
- Work with external regulatory consultants/CRO’s as required.
- Create Regulatory topic presentations and conduct educational activities for wider Pliant team members.
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.
- Bachelor’s degree in a scientific discipline required, advanced degree preferred.
- Minimum of 5 years of years in regulatory affairs in pharmaceutical industry.
- Experience and knowledge in preparation of initial INDs/CTA/IMPD and amendments ,health authority interactions and managing responses to health authority questions.
- Working knowledge of FDA, EMA and ICH regulatory guidance and regulations.
- Experience in working in small dynamic pre-commercial stage company is desirable.
- Strong collaboration and cross-functional team participation skills.
- Demonstrated ability to prioritize and manage multiple tasks while delivering on respective timelines for each project.
- Ability to interact effectively across all levels of management and external regulatory authorities.
- Preference for applying a solutions-oriented mindset and approach to resolving complex regulatory issues.
- High self-awareness and commitment to iterative learning and development.
- Effective oral and written communication skills, strong interpersonal skills, and detail oriented.
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 $160,000 - $170,000. 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 https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/.