Schrödinger is revolutionizing drug discovery through the use of breakthrough computational methods that are advancing internal programs into the clinic. We’re seeking an outstanding Clinical Operations Director / Sr. Director to join the NYC-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 Schrodinger.

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
• 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 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

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 strongly preferred)
• Excellent communication, influencing and negotiating skills. Strong project management skills with an ability to manage multiple priorities while maintaining attention to detail and demonstrated ability to meet timelines.
• Previous experience leading multiple trials; leading multidisciplinary trial teams in a complex matrix environment.
• Demonstrated ability to lead teams and build capabilities and establish effective working relationships with internal and external stakeholders. 
• A deep understanding of good clinical practices (GCP) and regulatory requirements for the successful conduct of clinical trials
• Robust computer skills (Microsoft Office Suite; G-Suite; IXRS platforms)