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

Senior Clinical Research Associate

Description: Pliant Therapeutics is a 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 for progress to meet unmet medical needs for patients and physicians. The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules.

Position Overview: The Senior Clinical Research Associate (Sr. CRA) is responsible for assisting the Clinical Trial Manager in managing and/or leading the day-to-day operations of assigned study execution tasks to ensure completion per established project team goals and objectives.  The Sr. CRA will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical trials are conducted on time and within budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.

Primary Responsibilities:

  • Participate in preparation of vendor requirements and project scope and selection of study vendors.
  • Manage vendors to ensure timely and quality deliverables (e.g. central laboratory, imaging).
  • Provide study progress updates to CTM and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
  • Provide monitoring oversight through review of monitoring schedules, metrics and reports.
  • Participate in study monitoring visits, including CRA oversight visits.
  • Participate in and, if appropriate, facilitate cross-functional study execution team meetings; liaise with other functional areas to coordinate clinical study activities.
  • Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
  • Develop study plans and participate in system set-up (e.g. UAT of EDC, IRT).
  • Participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
  • Review clinical study plans, reports, and study metrics.
  • Participate in study feasibility assessments and selection of countries and sites for study conduct.
  • Participate in creation and conduct of study-specific training at investigator meetings.
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with Pliant SOPs.

Requirements:

  • Bachelor’s degree required.
  • 6-9 years of experience working with CROs to manage clinical trials in US and ex-US.
  • Experience independently managing vendors (e.g. imaging, central lab, etc.).
  • Excellent organizational skills and attention to detail.
  • Effective communication and interpersonal skills.
  • Able to set priorities and juggle multiple demands.
  • Able to think critically and be a proactive problem-solver.
  • Able to work independently while exercising initiative, flexibility and sound judgment.
  • Comfortable working with different levels of the company including senior level management.
  • Demonstrated proficiency in Microsoft Word, PowerPoint and Excel.
  • Ability to operate in alignment with Pliant’s values

Senior Manager/Associate Director, Clinical Supply Chain

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: The Sr. Manager/Associate Director of Clinical Supply Chain is a key function at the junction of clinical operations and CMC organizations, responsible for forecasting and tracking clinical trial supplies.

Primary Responsibilities:

  • Work with Clinical Operations to understand clinical study demand requirements and ensure alignment with CMC to supply plans and timelines
  • Manage GMP inventory (both drug product and drug substance) throughout the supply chain, develop inventory reports, manage upcoming expiry and temperature excursions, and ensure drug accountability
  • Support the evaluation, selection and quality audit of packaging/labeling and distribution vendors
  • Coordinate daily activities with distribution vendors as required
  • Serve as internal lead for triaging of product complaints, temperature excursions, and deviations originating from distribution vendors and clinical sites.
  • Investigate deviations to determine root causes and implement corrective actions
  • Ensure label text and proofs are in accordance with applicable regulations, product specifications, and clinical study protocols
  • Support IRT user acceptance testing, supply strategy, and oversee ongoing supply activities in system
  • Provide expert input on ex-US importation requirement
  • Coordinate import/export activities and track shipments to depots and clinical sites.
  • Ensure all necessary documentations are available to the clinical sites
  • Develop supply chain management strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
  • Establish internal SOPs for supply chain management related activities

Requirements:

  • B.S. or M.S in scientific or health related field with 7+ years’ experience in Clinical Supply Chain Management
  • Understands comprehensive global pharmaceutical regulatory requirements
  • Knowledge of IRT system setup and functionality and proficiency with Excel modeling of supplies
  • Knowledge and understanding of international pharmaceuticals shipping requirements
  • Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Effective communication, interpersonal skills, collaboration and negotiation skills
  • Highly organized and efficient, able to orchestrate multiple projects simultaneously
  • Excellent project management skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team.
  • Strong interpersonal skills including verbal and written communication.
  • Ability to operate in alignment with Pliant’s values