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.

Our drug discovery and early clinical development team includes a cross-functional group of scientists and drug developers with experience working on all common target classes and therapeutic areas. The group is supported by more than 100 software developers and engineers as well as a large-scale compute infrastructure to apply our proprietary physics-based drug design and optimization platform. Several programs we have worked on have achieved Development Candidates, including progression to clinical development and FDA approval. You can view our entire pipeline of wholly-owned programs and collaborations here. 

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 leading multiple trials (i.e., leading multidisciplinary trial teams in a complex, matrixed environment)
• A deep understanding of good clinical practices (GCP) and regulatory requirements for the successful conduct of clinical trials
• Robust computer skills (e.g., Microsoft Office Suite, G-Suite, IXRS platforms)

Schrödinger understands it’s people that make a company great. Because of this, we’re prepared to offer a competitive salary, stock options, and a wide range of benefits that include healthcare (with dental and vision), a 401k, pre-tax commuter benefits, a flexible work schedule, and a parental leave program. We have catered meals in the office every day, a company culture that is relaxed but engaged, and over a month of paid vacation time.  Our Administrative and Human Resources departments also plan a myriad of fun company-wide events. New York is home to our largest office, but we have teams all over the world. Schrödinger is honored to have been selected as one of Crain’s New York Best Places to Work for the past three years running.

 

 

Sound exciting? Apply today and join us!