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

The Director of Clinical Development will be based in South San Francisco, report to the VP of Clinical Development, act as Pliant’s Medical Monitor, and be accountable for timely and high-quality execution of all clinical studies under his/her responsibility in the Pliant Portfolio. He/she will work in close cross-functional collaboration with Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Program Management, Quality Assurance, Biometrics and Data Management, Pharmacovigilance and Clinical Research Organizations (CROs). The Director of Clinical Development will support early to late-stage clinical studies across multiple indications, deliver on state-of-the-art clinical plans that will create differentiation and significant value for Pliant, and build and develop strong working relationships with Principal Investigators and study sites to optimize study conduct and position the Company as a true partner of choice in the clinical research landscape.

This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).

Responsibilities

• Act as the Sponsor’s Medical Monitor in close collaboration with clinical operations and CROs, responsible for conducting clinical studies in compliance with the protocol, interacting with study investigators and responding to protocol/medical questions related to participant eligibility, concomitant medications, safety issues and toxicity management
• Participate as a standing and/or ad hoc member in various clinical sub-teams (e.g., study execution team [SET], clinical study team [CST]) relevant to assigned molecule(s)/indication(s); support the CST lead with cross-functional integration, coordination, and alignment to enable effective and efficient clinical development plan execution
• Ensure that clinical study is conducted in compliance to GCP, company SOPs, governing laws, and regulations; review outstanding clinical or GCP issues, report and address issues across the study and, provide the study team with medical expertise during key activities
• Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Contribute to the design and development of clinical study protocols (Phases 1 to 3) from a concept sheet to a full protocol; participate in the review and finalization process with clinical operations, medical writing, regulatory affairs, clinical pharmacology, and other key cross-functional contributors
• In close collaboration with clinical operations, participate in the identification and selection of CROs, appropriate external investigators and sites
• Oversee and participate to protocol training, produce relevant training materials, and represent clinical development in Investigator meetings
• Coordinate with the study team to review and approve study processes and deliverables and participate in development of informed consent forms (ICF), case report forms (CRF), safety management plans, medical monitoring plans, statistical analysis plans (SAP) and clinical study reports (CSR)
• Lead the development of clinical responses to protocol questions by healthy authorities, independent review boards and ethical committees, in collaboration with regulatory affairs and/or clinical operations
• Collaborate with clinical teams to measure and monitor study progress against ob