Research Associate II – Biology: High-Throughput Screening (HTS)

Description:

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.

Position Overview

Immediate openings are available for Research Associates in Molecular and Cell Biology in the High-Thoughput Screening (HTS) Group.  This individual will join a dynamic and growing multidisciplinary team focused on screening and discovery of new drug candidates.  The primary responsibility of this position will be in the development and execution, cellular phenotypic assays utilizing robotic liquid handling platforms.  A key component of the position will be to provide regular, high quality assay results, and troubleshoot and develop approaches to optimize experimental procedures.  The successful candidate will work with some direct supervision of a Senior Research Associate or Scientist.

Responsibilities:

  • Independently execute assigned tasks following appropriate laboratory/technical procedures under supervision.
  • Make detailed observations, record and analyze data
  • Troubleshoot experiments, suggest improvements to supervisor
  • Evaluate and clearly report experimental results to supervisor and colleagues on a routine basis with special attention to data quality and reproducibility.
  • Learn new laboratory techniques, troubleshoot experiments, and ensure experiments are well designed and performed to a high standard.

Job Requirements:

  • BA/BS or M.S degree in Molecular Biology or Biochemistry or Cell Biology
  • Minimum of 5 years’ experience mammalian cell tissue culture working in a laboratory research environment in either industry or academia.
  • Broad practical experience and knowledge in common cell biology laboratory procedures (cell culture, cell adhesion assay, ELISA, SDS/PAGE, Western blot, etc.).
  • Experience with use of biological assays to characterize and optimize small molecules and data graphing analysis is an advantage.
  • Experience with flow cytometry and liquid handling automation is desirable.
  • Ability to evaluate and clearly communicate results.
  • Candidate should exhibit strong, positive attitude for teamwork and learning.
  • Ability to thrive in a culture of respect, accountability, transparency, and collaboration.

Stock Administration and Payroll Manager

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.

Position Overview:

The Stock Administrator and Payroll Manager will primarily be responsible for the day-to day stock administration oversight and  for our payroll activities.  Responsibilities include developing and maintaining partnerships with Legal, Human Resources, Accounting and other departments as needed. The successful candidate will have experience driving innovative and best-in-class payroll processes to ensure timely and accurate employee payroll and provide efficiencies in the payroll process.  This person will also thrive in a fast-paced environment and welcome the opportunity to make a difference in a growing, fast-paced organization.  This position will report to the Chief Human Resources Officer with a dotted line to the Corporate Controller.

Responsibilities:

  • Oversee the payroll and stock administration process
  • Manage the technical accounting aspect of compensation and stock-based compensation
  • Maintain Equity Edge database and ensure accuracy at all times.
  • Generate reports from Equity Edge database, including but not limited to participants’ summary.
  • Assist in answering employee questions on equity.
  • Manage the month-end close process for all payroll and stock compensation accounting including but not limited to journal entry review, account reconciliation, accounting memos
  • Review ESPP transactions, stock options, and awards grants, cancellations, and exercises and releases on a timely basis for all employees and other option and equity holders
  • Ensure that internal controls and procedures are followed to satisfy the periodic review of compliance with Sarbanes-Oxley
  • Lead all process improvement efforts for the compensation-related processes
  • Lead ad-hoc projects for payroll and stock compensation
  • Assist in accounting and finance system implementation projects
  • Manage 3rd party payroll vendor (ADP) and continuously drive improvements in operational processes and design and implement those initiatives.
  • Research and understand the applicability of a new rules, tax code or relevant legislation pertaining to payroll at the federal and state levels.
  • Absorb and manage the payroll process for new entities and/or countries, as needed.
  • Manage and support periodic external audit, 401(k), IRS and worker compensation audits.

More about you / Qualifications:

  • Bachelor’s degree required and CPP (Certified Payroll Professional) preferred.
  • Must have at least 3 years-experience in stock administration in a publicly traded company and 3 years direct payroll management experience.
  • Must have experience with stock options and RSUs.
  • Strong knowledge of US GAAP.
  • Knowledge of local and occupational tax withholding and reporting requirements for all US states.
  • Proficient using ADP for payroll.
  • Proficient in Microsoft Excel including advanced formula function.
  • Excellent problem-solving skills, analytical mindset with good judgement and high level of attention to details and accuracy.
  • Ability to maintain strict confidentiality of materials and information.
  • Able to multi-task, prioritize, and work under tight deadlines.
  • Ability to identify an assess relevant metrics/analytics to manage the payroll process and team.
  • Strong written and verbal communication skills; appropriately communicates with all levels of customers within the organization.
  • Able to work independently and effectively with a range of individuals.
  • Candidate should exhibit strong, positive attitude for teamwork and learning.
  • Ability to thrive in a culture of respect, accountability, transparency, and collaboration.

Please submit your resume to careers@pliantrx.com

Sr. Manager / Associate Director, Quality Assurance

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. 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 U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC), has completed Phase 1b testing. 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

The ideal candidate will have extensive experience managing cGMP aspects of Quality Systems, Quality Operations, and deep understanding and demonstrated working knowledge of Code of Federal Regulations (CFRs), ICH guidance documents, and other regulations that govern GxP compliance during clinical development of drug candidates.  This includes Quality oversight of GxP computerized systems and software validation, training, product disposition, and management of CMO/CTL activities related to manufacturing and testing of Pliant drug substance, bulk drug product, and packaged/labeled drug product for clinical trials.

Essential Functions

  • Review and approve change controls (CMO and internal) associated with validated computer systems, manufacturing, and testing of clinical products. Responsible for performing impact assessment of proposed changes.
  • Review and approve SOPs, Mater Batch Records, test methods, test results, labeling materials, specifications, analytical validation protocols and reports, and stability protocols and reports and associated records/data.
  • Perform oversight review and batch disposition of drug substance, bulk drug product and packaged/labeled drug product to be used in clinical studies and as applicable distribution. Review and approve records, including associated change controls, investigations (deviations, out-of-specification/out-of-trend), and analytical data.
  • Establish and maintain phase-appropriate procedures and processes that will effectively support cGMP activities during the various phases of drug development.
  • Review and approve Contract Manufacturing Organization (CMO) or Contract Testing Laboratory (CTL) investigations (deviations, out-of-specification/out-of-trend, complaints).
  • Perform internal annual audits as applicable.
  • Conduct trainings as needed for Quality owned systems.
  • Manage and trend product complaints.
  • Track, monitor, and generate Quality metrics for Management Reviews.
  • Apply the principles of ICH Q8 (Pharmaceutical Development) and Q9 (Risk Management) to the development of manufacturing processes. Ensure a systematic approach to development with pre-defined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management.
  • Support departmental functions and build partnerships and collaborate with applicable stakeholders in other areas of the business to ensure success of the Quality Operations and continuous process improvements.
  • Support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Represent QA on product development teams as applicable and assigned.

Requirements

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, and/or ability required.

  • Experience with batch disposition and review of analytical-related documents (test method and stability protocols and reports) is strongly preferred
  • In-depth knowledge of ICH guidelines related to stability (Q1A-Q1F), Analytical Validation (Q2), and Specifications (Q6A-Q6B)
  • Comprehensive working knowledge of local, state, federal, and international regulatory compliance pertaining to GMP, and European manufacturing requirements
  • Prior experience participating in or hosting regulatory inspections
  • Must be able to maintain compliance perspective necessary to meet deliverables and deadlines
  • Ability to make appropriate risk-based assessments and decisions based on phase-specific GMP requirements
  • In-depth knowledge and experience implementing phase appropriate procedures and processes related to QA Operations
  • Experience with interacting with domestic and international CMOs for early phase to late stage clinical trials
  • Strong and clear understanding of cGMPs and pharmaceutical industry best quality practices
  • Demonstrated leadership in cross-functional and culturally diverse team settings
  • Travel as needed

Preferred Education/Experience:

  • Bachelor’s degree in a scientific discipline
  • 15+ years of hands on experience in the pharmaceutical or biotechnology industry, with specific experience in GMP Quality Assurance, CMO oversight, auditing and Quality Systems
  • Experience in either a GMP manufacturing or Quality Control testing role is a plus
  • Knowledgeable in validation of computerized systems, software, and 21 CFR Part 11 Electronic Records, EU Annex 11 and Electronic Signatures
  • Understand and able to interpret regulatory authority regulations, guidelines and policies. Communicate and ensure compliance with Quality objectives, policies and procedures and escalate to Sr. Management as appropriate

Knowledge, Skills and Abilities:

  • Results and goals oriented
  • Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met
  • Excellent verbal, written, interpersonal, organizational, and communication skills are necessary with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship
  • Ability to work independently with minimal guidance
  • Ability to build and manage relationships with business partners
  • Accuracy and attention to detail
  • Excellent cross-functional team collaboration skills
  • Ability to grasp new technologies
  • Ability to work under deadline pressure, and to effectively prioritize and manage multiple projects (multi-task) and rapidly shifting priorities in a very fast-paced environment
  • Solution oriented with analytical thinking and problem-solving skills

Clinical Site Liaison (CSL)

Description:  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

Position Overview:  The Clinical Site Liaison (CSL) is a critical position within Pliant’s clinical team and will be responsible for providing non-promotional clinical, educational, and study support across Pliant’s Development portfolio.   The CSL position may be an office-based or a field-based member of the Clinical Operations team, reporting to the VP, Clinical Operations.

Primary Responsibilities:

  • Develops and maintains relationships with key clinical site personnel to build a well-informed and motivated clinical site base for Pliant’s clinical development portfolio.
  • Provides accurate clinical trial information to investigative sites (e.g. Principal Investigators, Sub-Investigators, Study Nurses, and Study Coordinators), in compliance with all relevant company policies.
  • Partners with sites to understand barriers to clinical trial participation and develops pragmatic solutions to enable successful execution of studies.
  • Identifies and communicates key clinical trial issues and insights from industry leaders to appropriate departments to help influence clinical trial execution including, but not limited to, site identification, site start-up, patient screening and accrual, and patient retention.
  • Facilitates the identification of clinical trial site (and corresponding community) educational needs around of IPF and PSC clinical trials.
  • Maintains business and clinical knowledge of the treatment landscape including current treatment strategies, current and pending competitors, and new therapeutic developments.
  • Participates in the education for clinical trial site professionals through presentations at office visits, investigator meetings, advisory boards, and other appropriate venues to enhance current and future clinical trial awareness.
  • Collaboration with internal (Clinical Operations and Clinical Development) and external stakeholders in support clinical trial sites’ needs.
  • Provides tailored presentations to clinical site personnel and community outreach organizations to meet specific needs of the audience.
  • Adheres to regulatory and compliance guidelines and company policies.

Requirements:

  • BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience.
  • Previous experience in a CSL, MSL, Community Engagement and Outreach role, or similar.
  • Ability to travel domestically 60% or greater (US based).
  • Working knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
  • Knowledge of ICH/GCP guidelines.
  • Excellent organizational skills and attention to detail.
  • Effective communication and highly-developed 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

Please submit your resume to careers@pliantrx.com

Clinical Trial Manager / Senior Clinical Trial Manager

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 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.
  • 10-12 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

Senior Clinical Research Associate (Sr. CRA)

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 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 Clinical Data Manager (Associate Director)

Description:  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

Position Overview:  The Senior Clinical Data Manager is responsible for data management activities across multiple studies from study start-up through study closure to ensure completion per established project team goals and objectives.  The Sr. CDM 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 data are complete, high quality and delivered on time and budget.

Primary Responsibilities:

  • Leads EDC development, including CRF development, EDC specification process and sponsor User Acceptance Testing including test scripts and execution logs, validation documents such as edit check documents, issue logs, UAT summary reports, etc.
  • Ensures complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans.
  • Ensures clinical data within EDC and other databases is of quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock Reviews and reconciles clinical database with external database/datasets.
  • Reviews coded adverse events and concomitant medication data.
  • Reviews data for discrepancies and communicates any outstanding issues.
  • Leads data cut / database lock process and release of data for analyses.
  • Coordinates transfers of SAS datasets or electronic data transfers from CROs.
  • Monitors and tracks the quality of all data management deliverables ensuring audit practices have been enacted to validate the quality and assurance of database content and supporting documents, from CROs as well as other external electronic data transfers.
  • Actively participates in team meetings and presents Data Management concerns and issues.
  • Effectively manage contracted vendors, or vendor groups within CRO, to ensure data are complete, accurate and delivered within agreed on timelines.
  • Collects and uploads data management documentation to the study TMF.
  • Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practice.

Requirements:

  • Bachelors Degree or equivalent in life science, computer science, or related discipline.
  • 10+ years of experience working within a pharmaceutical or CRO environment, with experience in managing Phase I, II and III studies, from start-up through closure.
  • Demonstrated proficiency in the data management processes.
  • Experience in managing external EDC vendors for Data Management.
  • Understanding of Clinical Data Interchange Standards Consortium (CDISC), CDASH, and SAS® terminology.
  • Understanding of the coding process and terms in MedDRA, WHODRUG and CTCAE.
  • Thorough knowledge of applicable regulatory rules and guidelines.
  • 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

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

Please submit your resume to careers@pliantrx.com

Senior Research Associate, Biology

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.

Position Overview

Immediate opening is available for a Senior Research Associate in Biology and Translational Sciences. This individual will join a dynamic and growing multidisciplinary team focused on discovery and advancement of new drug candidates and disease biomarkers in fibrosis.  The primary responsibility of this position will be in the development, characterization and execution of tissue, cellular and molecular biological assays.  The successful candidate will work under the direct supervision of a Senior Scientist or Scientist.

Responsibilities

  • Execute assigned tasks following appropriate laboratory/technical procedures.
  • Make detailed observations, record and analyze data, including maintain an organized physical and electronic laboratory notebook.
  • Evaluate and clearly report experimental results to supervisor and colleagues on a routine basis with special attention to data quality and reproducibility.
  • Learn new laboratory techniques, troubleshoot experiments, and ensure experiments are well designed and performed to a high standard.
  • Provide support to various team projects based on dynamic prioritization.

Qualifications

  • BS, MS in Cellular Biology or related field.
  • Minimum 4 years full time laboratory experience  (SRA I position) or 7 years full time laboratory experience (SRA II position), preferably in industry.
  • Broad practical experience and knowledge in common laboratory procedures including histology, cell culture, qPCR, and ELISA.
  • Experience working with ex vivo tissues (human and rodent).
  • Experience with use of biological assays to characterize and optimize small molecules and data graphing analysis.
  • Experience with cell isolation, single cell sequencing, and spatial transcriptomics is an advantage.
  • Candidate should be flexible with changes in lab schedule based on scope and prioritization of the project(s).
  • Candidate should exhibit strong, positive attitude for teamwork and learning.
  • Ability to thrive in a culture of respect, accountability, transparency, and collaboration.