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 Research Associate, DMPK

Position Overview

Pliant Therapeutics is seeking an enthusiastic Senior Research Associate to join our
department of Drug Metabolism and Pharmacokinetics (DMPK). In this rewarding, dynamic environment the successful candidate will be responsible for conducting in vitro assays including plasma protein binding, hepatocyte stability, CYP inhibition and related experiments to characterize the ADME properties of novel chemical entities. In addition, significant opportunity exists to directly support discovery project teams and represent DMPK in a highly impactful and visible role.

Responsibilities

  • Design and conduct in vitro ADME assays to support discovery/development project teams
  • Collect, analyze, summarize, and upload to internal databases and report high quality data in a timely manner
  • Effectively communicate and collaborate with multiple team members across disciplines
  • Participate in project and DMPK meetings

Experience

  • Hands-on laboratory experience with in vitro DMPK assays (plasma protein binding, metabolic stability, hepatocyte incubations, and related assays)
  • Experience with small molecule LC-MS/MS bioanalysis; sample processing and preparation
  • Solid understanding of key ADME/PK concepts and principles
  • Ability to troubleshoot in vitro assays and small molecule bioanalysis
  • Excellent interpersonal skills and team spirit
  • DMPK representation in project team environment

Education

  • Bachelor’s degree (B.S./B.A.) or equivalent in a scientifically related discipline

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.
  • 8-10 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

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

Sr. Scientist, DMPK

Sr. Scientist, DMPK

Description: 

Pliant Therapeutics is an early 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 meeting 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 is seeking passionate, creative and dedicated scientists to join our team and contribute to our mission.

Position Overview:

Pliant is seeking a versatile, self-motivated person to become an integral part of the DMPK team.  This position will be the drug metabolism and pharmacokinetics (DMPK) lead on project teams developing small molecule modulators of clinically meaningful targets in fibrosis.

This role will interact and collaborate cross-functionally with scientists in other groups, including chemists, biologists, biochemists, structural biologists, and computational chemists.

Job Responsibilities:

  • Serve as DMPK subject matter expert on dynamic cross-functional teams, provide in vitro and in vivo drug disposition data, interpretation, and presentations to teams.
  • Work closely with internal and external resources to assure a high level of quality and timely delivery of DMPK support.
  • Design and perform PK and PK/PD analyses to answer translational questions and to provide guidance for project teams.
  • Supervise associate scientists as required.

Qualifications/Experience: 

  • Requires a highly motivated individual with PhD degree in life sciences with 3-7 year experience.
  • Demonstrates excellent scientific skills in the design, execution and analysis of DMPK studies as well as organized data management and planning skills
  • Good verbal and written communication skills, demonstrated ability to work effectively in cross-functional teams
  • Requires hands-on experience in pharmacokinetics, drug metabolism or transporters

Expertise and experience in one or more of the following areas:

  • Mechanistic PK and pharmacodynamics (PD) analysis, design, interpretation, simulation, and reporting to provide guidance for drug discovery and development projects
  • Metabolite and metabolic soft-spot identification to facilitate structure-based discovery
  • Bioanalysis with previous experience in applying automation for higher throughput

 

Scientist/Sr. Scientist Biology – Antibody Engineering

Scientist/Sr. Scientist Biology – Antibody Engineering

Description:

Pliant Therapeutics is an early 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 is seeking passionate, creative and dedicated scientists to join our team and contribute to our mission.

Position Overview:

Immediate openings are available for Scientists/Sr. Scientists with experience in the fibrosis/inflammation area. Experience in cell signaling and previous research industry experience in drug development is a plus. This individual will join a dynamic and growing multidisciplinary team focused on discovery and advancement of new drug candidates and disease biomarkers. The primary responsibility of this position will be related to the field of fibrosis, notably in the discovery of novel signaling pathways.

Responsibilities:

  • Plan and execute experiments related to the evaluation of novel targets and signaling pathways.
  • Make detailed observations, record and analyze data.
  • Troubleshoot experiments.
  • Advance drug discovery programs by interacting with other biologists, chemists and external collaborators.
  • Contribute effectively to patent, report and scientific publication writing.
  • May have the opportunity to manage one or more Research Associates.

Job Requirements:

  • PhD. in Biochemistry, Molecular Biology, Structural Biology, or related field.
  • A minimum of 5 years of experience working in antibody engineering, preferably in the pharmaceutical or biotechnology industry.
  • Experienced in antibody humanization and maturation.
  • In-depth knowledge of state-of-the-art technologies and methods for design and optimization of antibody and antibody-based therapeutics.
  • Hands-on experiences with phage-display, yeast-display, and/or antibody engineering are required
  • Strong molecular biology skills
  • High level of creativity and productivity with strong problem solving skills.
  • Ability to champion the biology efforts into new directions to achieve project milestones.
  • Strong evidence of conceptual thinking, active follow through and vigorous scientific curiosity.
  • Proven ability to work well with others in a dynamic and highly collaborative environment.
  • Exceptional interpersonal, verbal and written communication skills