Clinical Operations Director/Senior Director

March 28

Apply Now

Receive Emails with Similar Jobs

Schrödinger

WebsiteLinkedInAll Job Openings

Transforming drug discovery and materials research

Computational Chemistry Software • Molecular Modeling • Drug Design • Biologics • Materials Design

201 - 500

Description

• Oversee, lead and matrix manage cross-functional study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance • Accountable for all operational aspects of clinical studies, including management of external service providers. Monitor and manage performance of external service providers, escalate issues where appropriate, and make the appropriate changes to ensure trial conduct is completed in compliance and meets company’s business objectives. • Proactively monitor and report trial progress and performance, timelines, and financial metrics on an ongoing basis to study and program teams • Responsible for reviewing and/or approving clinical study documents, such as project timelines, pharmacy manuals, laboratory / PK manuals, informed consent, study start-up plans, monitoring plans, CRFs, data monitoring plan, edit checks, safety plans, DMC charter, close-out plans, and CSRs • In collaboration with CRO, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient recruitment strategies to deliver enrollment targets • Ensure compliance training for clinical study teams and sites • Oversee site monitoring activities • Accountable for accuracy of trial information in all trial databases and tracking systems. Ensure that all TMF-related documentation is current and on-file. • Prepare teams for regulatory agency audits and address any audit observations appropriately • Accountable for overall management of clinical study manager(s), who contribute to the planning, conduct and reporting of clinical trials. Contribute to talent and career development of staff through active participation in on-boarding, training and mentoring activities. • Responsible for implementation of best practices and standards for clinical operations, including sharing lessons learned. • Develop internal SOPs as needed

Requirements

• BS/BA in a science or health-related field (Master’s or PhD preferred) • At least ten years of clinical research and/or clinical project management experience in global clinical trials (experience with early development oncology - i.e., Phase 1 oncology and/or hematology trials is strongly preferred)

Benefits

• High-visibility role with responsibility for the first clinical trial conducted exclusively by Schrodinger • Opportunity to work with a cross-functional team of scientists and drug developers • Access to a large-scale compute infrastructure and proprietary drug design platform