Description

The Director of Clinical Development will be based in South San Francisco, report to the Senior Director of Clinical Development, and be responsible for the execution of multiple Pliant clinical studies across therapeutic areas, and for monitoring safety in assigned clinical trials. The candidate will work in close cross-functional collaboration with Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Program Management, Quality Assurance, Biometrics and Data Management, Pharmacovigilance and Clinical Research Organizations (CROs). The Director of Clinical Development will serve as study physician for multiple studies across different indications and may participate in the development of state-of-the-art clinical plans that will create differentiation and significant value for Pliant. This role will be key to ensuring the safe execution of Pliant’s clinical studies within the clinical study teams.

Responsibilities

• Responsible for medical monitoring activities across Pliant’s programs in close collaboration with the therapeutic-area specific clinical development leads, study directors, clinical operations and CROs.
• Responsible for conducting clinical studies in compliance with the protocol, interacting with study investigators and responding to protocol/medical questions related to participant eligibility, concomitant medications, safety issues and toxicity management
• Participate and engage in regular safety review meetings for Pliant’s programs and closely collaborate with CRO medical monitors for Pliant’s clinical programs
• Support pharmacovigilance processes; review individual data with Serious Adverse Events (SAEs) and important medical events; author and/or review safety narratives and related regulatory reports (CIOMS, MedWatch)
• In charge of regular and timely safety surveillance of assigned clinical trials, including utilization of software to review core safety data
• Participate as a standing and/or ad hoc member in various clinical sub-teams (e.g., study execution teams) relevant to assigned molecule(s)/indication(s); support the clinical lead and study director with cross-functional integration, coordination, and alignment to enable effective and efficient clinical development plan execution
• Ensure that clinical studies are conducted in compliance with GCP, company SOPs, governing laws, and regulations; review outstanding clinical or GCP issues, report and address issues across the study and, provide the study team with medical expertise during key activities
• Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Contribute to the design and development of clinical study protocols (Phases 1 to 3) from a concept sheet to a full protocol; participate in the review and finalization process with clinical operations, medical writing, regulatory affairs, clinical pharmacology, and other key cross-functional contributors
• In close collaboration with clinical operations, participate in the identification and selection of CROs, appropriate external investigators and sites
• Coordinate with the study team to review and approve study processes and deliverables and participate in development of informed consent forms (ICF), case report forms (CRF), safety management plans, medical monitoring plans, statistical analysis plans (SAP) and clinical study reports (CSR)
• Participate in the development of clinical responses to protocol questions by healthy authorities, independent review boards and ethics committees, in collaboration with regulatory affairs and/or clinical operations
• Collaborate with clinical teams to measure and monitor study progress against objectives and plans
• Ensure that all clinical studies are conducted within timeline, budget, and quality specifications
• Review patient profiles, and study level data; review coding of adverse events (AEs), concomitant medications and protocol deviations
• In close collaboration with clinical operations, data management, biometrics and CROs, participate in all reviews and procedures required for database lock
• Review study data outputs; develop topline study reports in collaboration with biometrics and relevant stakeholders (e.g., clinical pharmacology, translational sciences, etc.)
• Collaborate cross-functionally in the development of clinical sections of investigator brochures (IB), annual safety reports, IND and IMPD updates

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.

• M.D. degree and at least 2 years of clinical research and development experience within the pharmaceutical/biotech industry
• Clinical development experience in an industry setting ranging from Phases 1 to 3 preferred
• Experience with development of clinical study related documents (e.g., clinical trial protocols, Investigator’s Brochures, clinical study reports)
• Knowledge of clinical trial methodology, statistics, regulatory and compliance requirements governing clinical trials, including GCP
• Previous experience as Medical Monitor in Phase 1-3 studies preferred
• Experience in MedDRA coding, review of concomitant medications and protocol deviations, safety reviews and use of safety monitoring software, signal detection, etc. preferred

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 $270,000 - $295,000. 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.