Director, Early-Stage Clinical Development South San Francisco, CA
1 month ago
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 ??v??1 and ??v??6 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 ??v??8 and ??v??1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies. Description
Reporting to the Head of Clinical Pharmacology, the Director will support early–stage clinical development and strategy for new drug candidates, spanning across multiple therapeutic areas and new indications. The Director will assume a hands–on role in the design, planning, implementation, conduct, and oversight of first–in–human and early–stage clinical trials in close partnership with Nonclinical, Biology and Translational Sciences, Regulatory Affairs, Clinical Operations, and Program Management. The Director will lead the drafting of clinical sections of INDs through cross–functional collaboration, ensure the 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. The Director will work in close collaboration with cross–functional teams to develop the clinical strategy and achieve the clinical development goals and deliverables for assigned programs. The candidate must have relevant and direct experience in drug discovery and early–stage clinical development (Phases 1 and 2) within the pharmaceutical and/or biotech industry. Experience in oncology is a plus.
This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco). Responsibilities
Support the clinical development of Pliant's early–stage programsLead clinical sub–teams and drive the timely and high–quality execution of early assets and programs within the portfolioParticipate in the ongoing review of clinical study data, provide scientific oversight of CSR authoring, and prepare data for presentation at scientific/medical meetings as well as for abstracts and peer–reviewed publicationsDevelop early–stage clinical strategies and identify significant opportunities for differentiation of Pliant drug candidates, based on unmet needs and therapeutic landscapeSupport clinical advisory boards as needed to advance early–stage assetsBe accountable for creating a detailed and state–of–the–art global clinical development plans from pre–IND to Phase 2a, as needed across multiple indicationsLead the drafting of the clinical sections of INDs in close collaboration with Nonclinical, Biology and Translational Sciences, Regulatory Affairs, Clinical Operations, and Program ManagementEnsure that scientific rigor and innovation continue to be integrated into all early–stage programs and drive all early–stage clinical development strategiesBuild and maintain relationships with key opinion leaders globally to identify new opportunities, obtain strategic guidance (including via scientific or clinical advisory boards) and develop study concepts into state–of–the–art and workable study protocolsWork in close collaboration with Clinical Operations and designated CROs and Medical Monitors 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 coding reviews; statistical analysis plans; develop/present clinical slides at Investigators Meetings)Draft/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 authoritiesEnsure compliance to GCP, meet all statutory requirements and internal company policies and standard operating proceduresSupport Business Development activities by providing clinical input, technical expertise, and drafting early development plans for Pliant's pre–clinical programsCollaborate with Biology and Translational Sciences and Clinical Pharmacology to provide clinical support and guidance for translational studies or develop translational components for early–stage trialsDomestic and global travel may be required Qualifications 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, abilities, and prior experience required. Advanced degree in a health science related field (MD, PhD, PharmD) with a minimum of 8 years' experience in the biotech/pharma industryExperience in the drafting of INDs and the management and execution of first–in–human and early–stage clinical trialsExperience in immune–oncology, fibrosis, muscular dystrophies and/or rare diseases is a definite plusSound 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 regulationsHigh scientific acumen and demonstrated ability to independently evaluate, interpret and present complex scientific dataSound understanding of statistics and demonstrated ability to critically evaluate complex drug development programsDemonstrated ability to work collaboratively with a multi–disciplinary team of peers, consultants and vendorsExcellent communication skills including written, oral, and presentation skills. Evidence of publication of original scientific papers in translational and/or clinical research will be valuedAble to work effectively in a small dynamic organization; ability to assume multiple roles and responsibilities and meet stretch goalsStrong leadership skills that focus on teamwork and building alliances; ability to resolve conflicts and to negotiate effectivelyPositive approach to work and ability to motivate team members to meet timelines and project goals is requiredAbility to develop strong relationships with study investigators and key opinion leaders within a given therapeutic area 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 $245K – $255K. 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 fulltime positions.-
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