Director, Regulatory Affairs CMC
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 αvβ1 and αvβ6 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/3 trial of bexotegrast for the treatment of IPF.
Pliant is conducting 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.
Description
Pliant is seeking a dedicated and creative regulatory CMC professional to contribute to the Company’s mission of helping patients with life-threatening fibrotic diseases. The position will report to the Sr. Director of Regulatory CMC and will be responsible for developing the regulatory CMC strategy for Pliant’s development programs. This includes strategic and operational leadership of global regulatory CMC activities for molecules in the pre-clinical to clinical stage and NDA readiness and post-approval activities. This position may also support clinical/nonclinical regulatory activities as needed.
This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).
Responsibilities
- Develop CMC regulatory strategies in collaboration with regulatory and CMC SMEs to meet business objectives for all Pliant’s development projects, registration, NDA-readiness, and commercial launch
- Lead the authoring and timely submission of regulatory dossiers as required to support global clinical trial applications, including initial INDs/IND amendments, IMPDs, annual reports, requests for information, etc.
- Support interactions with global regulatory authorities to ensure acceptance of CMC information in support of regulatory submissions and applications, including leading the authoring of CMC content in briefing documents.
- Ensure that CMC content in regulatory applications is complete, well-written, and meets all relevant requirements
- Evaluate proposed manufacturing changes for global impact to ongoing and existing applications and provides strategic regulatory guidance for optimal implementation of changes
- Participate on project teams and provide expertise on CMC regulatory matters.
- Knowledge of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to CMC and RA colleagues
- Ensure product labeling is in compliance with regulatory requirements in all regions
- Assure compliance with regulatory standards and guidance documents
- Conduct regulatory risk assessments on issues that arise in development teams
- May lead or support the generation or revision of SOPs related to regulatory affairs and inter-facing Quality workstreams.
- Work with external regulatory consultants/CRO’s as required.
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.
- Bachelor’s degree in a scientific discipline required, advanced degree preferred
- Minimum of 12 years’ experience with 6-10 years in regulatory affairs CMC experience with global clinical phase submissions and health authority interactions
- Small molecule development or manufacturing experience required, biological experience preferred
- Experience and knowledge in preparation of initial INDs/IMPD and amendments
- Experience in health authority interactions and addressing health authority questions
- Deep knowledge of FDA, EMA and ICH regulatory guidances and regulations
- Small company / pre-commercial stage company experience desirable
- Excellent collaboration and cross-functional team participation skills
- Ability to prioritize and manage multiple tasks while delivering on respective timelines for each
- Confidence in interacting with varying levels of internal 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 communicator, verbal and written, strong interpersonal and influencing skills
- Accuracy and attention to details
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 $230K – $240K. 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/.
