Associate Director/Director, Regulatory Affairs CMC

Pliant Therapeutics is a clinical stage biopharmaceutical company focused on developing 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 that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the US FDA in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and is currently initiating Phase 2 clinical trials for IPF and PSC. 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 passionate, creative and dedicated regulatory CMC professional to contribute to the Company’s mission of helping patients with life-threatening fibrotic diseases. The position will report to the Head of Regulatory Affairs and will lead 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.

Description

Essential Functions

 

  • Independently develop CMC regulatory strategies to meet business objectives for Pliant’s development projects
  • Lead the authoring, review, and timely submission of regulatory dossiers as required to support global clinical trials, including initial INDs/IND amendments, IMPDs, annual reports, requests for information, etc.
  • Lead Regulatory Authority interactions with regards to CMC
  • Participate on project teams and provide expertise on CMC regulatory matters.
  • Establish, manage, and maintain a 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.
  • Work with external regulatory consultants/CRO’s as required.

 

 

Requirements

  • Bachelor’s degree in a scientific discipline required, advanced degree preferred
  • Minimum of 7 years of related pharmaceutical or biopharmaceutical industry experience including at least 2 years in regulatory affairs supporting CMC submissions
  • 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
  • Working knowledge of FDA, EMA and ICH regulatory guidances and regulations
  • Small company / pre-commercial stage company experience desirable
  • Strong 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 detail
  • Ability to operate in alignment with Pliant’s values

Senior Associate/ Manager, Regulatory Affairs

Pliant Therapeutics is a clinical stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases.  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 designed to be a selective inhibitor of αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. 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.   The Company is seeking passionate, creative and dedicated individuals to join our team and contribute to our mission.

Description

Pliant is seeking a passionate and dedicated regulatory professional to contribute to the Company’s mission of helping patients with life-threatening fibrotic diseases. The position will report to the Head of Regulatory Affairs and will lead the planning and compilation of global regulatory submissions and provide clinical trial support for Pliant’s development programs.

Essential Responsibilities

  • Lead the planning, compilation, and timely submission of regulatory deliverables in accordance with applicable regulations, including initial IND applications and amendments and international equivalents as well as routine submissions such as annual reports etc.
  • Representing the Regulatory Affairs function on assigned cross-functional project teams and with external vendors
  • Manage the regulatory sub-team meetings and lead meetings with regulatory objectives
  • Assist in coordinating meeting with Regulatory Authorities and associated briefing document preparation
  • Researching and interpreting global regulations to support regulatory objectives and deliverables
  • Proactively identify and communicate potential regulatory issues/risks and recommend solutions to cross-functional and regulatory affairs team
  • Manage regulatory document management systems to ensure archiving and tracking of regulatory deliverables

Requirements

  • Bachelor’s degree in a scientific discipline required, advanced degree preferred
  • Minimum of 2-3 years in Regulatory Affairs or related pharmaceutical or biopharmaceutical industry experience
  • Experience in management and submission of clinical/nonclinical global regulatory documents
  • Experience and knowledge in preparation of initial INDs and amendments preferred
  • Experience in participating and representing Regulatory Affairs on clinical study management teams preferred
  • Experience with regulatory document management systems
  • Working knowledge of FDA, EMA and ICH regulatory guidance and regulations
  • Strong collaboration and cross-functional team participation skills
  • High self-awareness and commitment to iterative learning and development
  • Effective communicator, verbal and written, strong interpersonal skills with the ability to communicated cross-functionally in a collaborative manner
  • Commitment to accuracy and attention to detail
  • Ability to operate in alignment with Pliant’s Values

Medical Director/Senior Medical Director

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 αvβ6 and αvβ1 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:

Reporting to the VP, Clinical Development, the Medical Director manages the day-to-day activities of clinical development of drug candidates, from early to late-stage, and across multiple therapeutic areas. The Medical Director will assume a hands-on role in the planning, implementation, conduct and oversight of clinical trials, in close partnership with the Clinical Operations group.

The candidate must have relevant and direct experience in clinical development within the pharmaceutical or biotech industry (at least 5 years preferred). Strong clinical background, high scientific interest and effective communication skills are required.  The Medical Director will be responsible for ensuring proper clinical conduct of study protocols in compliance with GCP and local/global trial regulations, oversee and provide clinical guidance to CRO medical monitors (and study investigators, as needed) and study team, lead development of study protocols, protocol amendments and clinical study reports. The Medical Monitor will work in close collaboration with Clinical Operations and Project Management  to achieve clinical development goals and deliverables.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Develop study protocols and obtain cross-functional input to execute on clinical development strategies
  • Work in close collaboration with Clinical Operations and designated CROs to ensure quality and timely execution of the clinical programs (i.e.: study startup, conduct and database lock activities; medical monitor training and oversight; safety monitoring plans; protocol deviation lists; data and AE codingreviews; statistical analysis plans; develop/present clinical slides at Investigators Meetings)
  • Write/review/edit clinical study reports, investigator brochures and clinical aspects of regulatory submissions and clinical trial applications; supports all other regulatory activities, including protocol-related questions from health authorities
  • Ensure that the Clinical Development department is working in lockstep with Clinical Operations and Project Management and along with Regulatory Affairs, Drug Safety/Pharmacovigilance, Clinical Pharmacology and Medical Affairs, as appropriate, for effective and high-quality execution of various programs

Domestic and global travel may be required

KNOWLEDGE AND SKILL REQUIREMENTS:  

  • M.D. degree with a minimum of 5 years industry experience, in the management and execution of Phase 1-3 trials; clinical pharmacology background a plus
  • Experience in fibrosis and/or rare diseases is a definite plus
  • Sound and comprehensive knowledge of the drug development process, trial management and vendor oversight, safety reporting, MedDRA and WHODrug dictionaries, study methodology, data reviews, statistical analysis plans and local and global clinical trial regulations
  • High scientific acumen and demonstrated ability to independently evaluate, interpret and present complex scientific data
  • Sound understanding of statistics and demonstrated ability to critically evaluate complex drug development programs
  • Demonstrated ability to work collaboratively with a multi-disciplinary team of peers, consultants and vendors
  • Excellent communication skills including written, oral, and presentation skills.Evidence of publication of original scientific papers in translational and/or clinical research will be valued
  • Able to work effectively in a small dynamic organization; ability to assume multiple roles and responsibilities and meet stretch goals
  • Strong people management skills that focus on teamwork and building alliances; ability to resolve conflicts and to negotiate effectively
  • Positive approach to work and ability to motivate team members to meet timelines and project goals is required
  • Ability to develop strong relationships with study investigators and key opinion leaders within therapeutic area.

Senior Clinical Trial Manager

Department: Clinical Operations

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 Clinical Trial Manager is responsible for managing the day-to-day operations of assigned clinical studies to ensure completion per established project team goals and objectives.  The CTM will report to the VP, Clinical Operations and 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 budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.

Primary Responsibilities:

  • Lead internal cross-functional study team for assigned studies to identify risks and mitigation strategies.
  • Manage the day-to-day operations of assigned studies.
  • Manage clinical research organizations (CROs) to ensure timely and quality deliverables.
  • Lead preparation of vendor requirements and project scope and selection of study vendors.
  • Lead feasibility assessment and selection of countries and sites for study conduct.
  • Implement appropriate systems, standards and processes to ensure quality at the level  of investigative sites, vendors and data.
  • Oversee maintenance of clinical trial master files.
  • Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews.
  • Author, audit and/or edit written summaries of data reports, presentations, training  material, and study documents (including pharmacy, laboratory, and operations manuals).
  • Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members.
  • Create and conduct study-specific training at investigator meetings.
  • Review study invoices and participate in accrual reviews to track the financial status of the study against budget.
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.

Requirements:

  • Bachelor’s degree required.
  • 10 years of experience working with CROs to manage clinical trials in US and ex-US.
  • 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