Director/Senior Director, Clinical Operations

Schrödinger is revolutionizing drug discovery through the use of breakthrough computational methods that are advancing internal programs into the clinic. We’re seeking a Director/Senior Director of Clinical Operations to join the New York-based Early Clinical Development team. This hire will oversee study management activities, budgets, and contracts for Schrödinger’s clinical asset(s) and report to the Global Head of Clinical Operations & Strategy. This is a high-visibility role with responsibility for the first clinical trial conducted exclusively by Schrödinger.

Who will love this job:

• A seasoned clinical operations professional who enjoys performing the day-to-day tasks of clinical operations, but also has the knowledge and experience to build out the end-to-end clinical capabilities of a developing clinical research organization
• An excellent communicator and negotiator with excellent project management skills and an ability to manage multiple priorities while maintaining attention to detail
• A leader and team-builder who can establish effective working relationships with internal and external stakeholders 
• A team player who is goal-oriented and has strong leadership skills to oversee clinical study teams, including CROs and vendor partners, to achieve results
• An advocate for patient centricity to ensure that our clinical trials always keep the needs of patients at the forefront of what we do

What you’ll do:

• Oversee, lead and matrix manage cross-functional study team, external service providers (CROs, vendors, etc.), and clinical sites to ensure all trial goals are met according to timelines, budget, and quality standards, and in compliance 
• Account 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 necessary changes to ensure compliant completion of trial conduct in a way that meets our business objectives
• Proactively monitor and report trial progress and performance, timelines, and financial metrics on an ongoing basis to study and program teams 
• Review and/or approve 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
• Maintain accurate trial information in all 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
• Account 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 
• Implement best practices and standards for clinical operations
• Develop internal SOPs as needed

What you should have:

• 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 preferred)
• Previous experience leadi