Tbwa Chiat/Day Inc
Clinical Trial Manager
Tbwa Chiat/Day Inc, San Francisco, California, United States, 94199
Pliant Therapeutics is a late-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 to meet the unmet medical needs of physicians, patients, and families impacted by fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.
The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF.
Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.
DescriptionThe 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 a Senior CTM, Associate Director, or Director of Clinical Operations, and will work closely with a cross-functional team in a fast-paced high growth environment to ensure that clinical trials are conducted on time and budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements. This is a hybrid position, with a 3-day in the office expectation (South San Francisco).
Responsibilities
Manage the day-to-day operations of assigned studies or specific study deliverables as directed by the program lead.
Manage clinical research organizations (CROs), central labs, and/or other vendors (e.g., imaging, ECG, specialty labs) to ensure timely and quality deliverables.
Perform monitoring oversight, as needed.
Identify risks and mitigation strategies on assigned studies.
Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data.
Oversee assigned studies through review of monitoring visit reports and Trial Master File QC reports.
Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data-cleaning activities, and data reviews.
Author, review and/or edit written summaries of data reports, presentations, training materials, study plans, study manuals (pharmacy, laboratory), and other study documents.
Develop investigator and site monitor training materials for study start-up and maintenance.
Review vendor work orders, change orders, and invoices and participate in accrual reviews to track the financial status of the study against budget.
Adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.
As needed, complete other responsibilities and tasks related to trial management, study conduct, data integrity, GCP compliance and other regulatory requirements, study-related engagement with internal and external stakeholders, patient community, and the scientific and medical community.
QualificationsTo perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
5+ years of experience (3-6 years of vendor and CRO management) in support of clinical trials.
Excellent organizational and time management skills.
Effective communication and interpersonal skills.
Able to set priorities and juggle multiple demands.
Able to think critically and be a proactive problem-solver.
Ability to identify and provide solutions to logistical and/or operational challenges.
Ability to efficiently perform multiple tasks, adapt, and manage changing priorities.
Able to work independently while exercising resourcefulness, initiative, flexibility, and sound judgment.
Comfortable working with different levels of the company including senior level management.
Ability to read and understand regulatory documents and Standard Operating Procedures.
Demonstrated proficiency in Microsoft Word, PowerPoint and Excel.
Demonstrates a growth mindset and ability to take guidance productively.
Ability to demonstrate Pliant’s values.
Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).
The annual base salary for this role is $155K – $165K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for full-time positions.
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The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF.
Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.
DescriptionThe 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 a Senior CTM, Associate Director, or Director of Clinical Operations, and will work closely with a cross-functional team in a fast-paced high growth environment to ensure that clinical trials are conducted on time and budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements. This is a hybrid position, with a 3-day in the office expectation (South San Francisco).
Responsibilities
Manage the day-to-day operations of assigned studies or specific study deliverables as directed by the program lead.
Manage clinical research organizations (CROs), central labs, and/or other vendors (e.g., imaging, ECG, specialty labs) to ensure timely and quality deliverables.
Perform monitoring oversight, as needed.
Identify risks and mitigation strategies on assigned studies.
Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data.
Oversee assigned studies through review of monitoring visit reports and Trial Master File QC reports.
Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data-cleaning activities, and data reviews.
Author, review and/or edit written summaries of data reports, presentations, training materials, study plans, study manuals (pharmacy, laboratory), and other study documents.
Develop investigator and site monitor training materials for study start-up and maintenance.
Review vendor work orders, change orders, and invoices and participate in accrual reviews to track the financial status of the study against budget.
Adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.
As needed, complete other responsibilities and tasks related to trial management, study conduct, data integrity, GCP compliance and other regulatory requirements, study-related engagement with internal and external stakeholders, patient community, and the scientific and medical community.
QualificationsTo perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
5+ years of experience (3-6 years of vendor and CRO management) in support of clinical trials.
Excellent organizational and time management skills.
Effective communication and interpersonal skills.
Able to set priorities and juggle multiple demands.
Able to think critically and be a proactive problem-solver.
Ability to identify and provide solutions to logistical and/or operational challenges.
Ability to efficiently perform multiple tasks, adapt, and manage changing priorities.
Able to work independently while exercising resourcefulness, initiative, flexibility, and sound judgment.
Comfortable working with different levels of the company including senior level management.
Ability to read and understand regulatory documents and Standard Operating Procedures.
Demonstrated proficiency in Microsoft Word, PowerPoint and Excel.
Demonstrates a growth mindset and ability to take guidance productively.
Ability to demonstrate Pliant’s values.
Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).
The annual base salary for this role is $155K – $165K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for full-time positions.
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