Vice President, Clinical Development

Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant seeks to develop targeted treatments to slow or halt the progression of multiple life-threatening fibrotic diseases. The company’s lead product candidate, PLN-74809, is designed to be a selective inhibitor of αvβ1 and αvβ6 integrins, which play  key roles 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 is currently in Phase 2 testing for IPF. Pliant’s second product candidate, PLN-1474, is designed to be an oral, small molecule selective inhibitor of αvβ1, targeting late-stage liver fibrosis and is partnered with Novartis.

Position Overview

Pliant is seeking a VP of Clinical Development with primary responsibility to lead the advanced clinical development of our first program. In addition to driving successful advanced development of the pipeline, the role includes being a thought partner with the CMO for innovative fibrotic disease development strategies.

Primary Responsibilities:

• Accountable for creating detailed and state of the art global clinical development plans from IND to NDA/MAA
• Drive the timely and high-quality execution of multiple assets and programs within our portfolio
• Develop and manage a world class development team and ensure that it is being challenged and developed to be ready to take on new roles and programs as the portfolio matures
• Provide clinical leadership and foster cross-functional collaboration for creating and delivering clinical plans and program strategies
• Ensure excellence in both strategy and execution, by partnering closely with clinical operations, regulatory affairs, nonclinical, clinical pharmacology, project management, biostatistics and data management
• Partner with regulatory affairs to support regulatory submissions and develop regulatory strategies. Represent clinical development during written or face-to-face regulatory interactions
• Ensure that scientific rigor and innovation continues to be integrated into and drives all clinical development strategies
• Ensure compliance to GCP, meet all statutory requirements and internal company policies and standard operating procedure
• Build and maintain relationships with key opinion leaders globally to ensure therapeutic strategy is aligned with patient, clinician and wider healthcare needs
• Adeptly translate development program strategies into clinical study concepts that can be executed without compromising the scientific rigor of the study
• Ensure data mining from existing studies is accurate and meets protocol standards and provide clinical guidance on study-related publication activities
• Support Business Development activities by providing scientific and technical expertise, insight into patient trends and modern technologies

Requirements:

• MD with fibrotic disease expertise or other relevant area, with at least 10 years’ experience working in the biotech and/or pharmaceutical industry
• Experience in IPF, liver disease including PSC and rare diseases drug development is a definite plus
• Strong early and late stage clinical development experience, in either small molecules or large molecules, preferably across multiple indications
• Hands-on experience in assembling, onboarding, managing and developing a clinical development team
• Proven track record of collaboratively leading cross-functional teams and the ability to partner with others to devise innovative development strategies
• Knowledgeable in current and possible future trends, technologies, policies, treatment guidelines and competitive landscape in fibrotic disease drug development and global health authority requirements for drug approval
• Has led or been intimately involved in face-to-face regulatory interactions (e.g.: Pre-IND, End-of-Phase 2 or pre-NDA meeting[s]) with the FDA, EMA or other key regulatory agencies, and be suitably qualified to defend clinical programs

The appointed candidate must be able to demonstrate:

• Hands-on mentality, able to “hit the ground running” and “run the show”
• Works best in an environment that demands high accountability, integrity and a high degree of autonomy, often in the context of limited resources
• Highly developed problem-solving capabilities with proven ability to balance timelines, quality and deliverables in multiple indications and development stages
• A strong commitment to achieving corporate and clinical development objectives while maintaining the highest ethical, regulatory and scientific standards
• Able to lead, manage and develop reports and help resolve team issues with the highest level of integrity. Self-aware and responsive to needs of others, demonstrates elevated levels of empathy, respect and engagement
• Have strong communication skills, oral and written, along with exceptional leadership skills and a track record of fostering cross-functional collaboration and timely and high-quality delivery of results
• Also, the ability to build relationships, and lead and influence teams in a thoughtful and purposeful fashion, to achieve defined objectives
• Attacks everything with drive and energy, endeavors to finish everything he/she starts