Clinical Data Solutions And Sciences (Senior Director)

Schrödinger seeks an outstanding leader of Clinical Data Solutions and Sciences (Senior Director) to join our Early Clinical Development Team. This hire will report to the Global Head of Clinical Operations and Strategy and will play an essential role in a broad range of activities necessary to drive and manage Clinical Data for first-in-human and proof-of-concept drug development.
As an integral member of the clinical development team, the Clinical Data Solutions and Sciences will be responsible for driving data collection/extraction and reporting strategy in alignment with the clinical protocol and industry standards. Responsibilities include oversight of CRO-led implementation, execution, delivery/reporting and submission of Clinical Data. You will closely collaborate with cross-functional experts in clinical sciences, clinical operations, regulatory sciences, and medical writing to drive the success of our clinical trials. You will also be responsible for supporting data needs for clinical biomarkers and clinical pharmacology.
Schrödinger applies a proprietary physics-based drug design and optimization platform to the drug discovery process, which expeditiously advances assets into the clinic. The Clinical Development team is responsible for transitioning these assets through for demonstrating proof of concept. This environment is dynamic and fast-paced, offering an exciting opportunity for impactful contributions.
Who will love this job:

• A seasoned, self-motivated Clinical Data Solutions and Sciences leader who enjoys performing the day-to-day tasks of Clinical Data sciences, but also has the knowledge and experience to establish the end-to-end capabilities of a developing Clinical Data Solutions and Sciences organization.
• A team player who is goal-oriented and has strong leadership skills to collaborate with cross-functional Clinical Data teams, including CRO and vendor partners, to achieve results on Clinical Data sciences timelines and deliverables.
• An experienced clinical researcher who can work independently to decipher complex clinical trial protocols, identify the Clinical Data required for the analysis of the study and align to appropriate Clinical Data standards (e.g., CDISC, CDASH).
• An experienced Clinical Data scientist with expert knowledge in the identification, set-up, testing and management of various electronic clinical trials data systems.
• An excellent communicator with a strong work ethic who thrives in a dynamic, high growth, entrepreneurial environment.
• A natural mentor with a proven ability to grow and develop talent.

What you will do:

• Lead and organize the Schrodinger technology systems strategy in collaboration with preferred vendors to support the timely and efficient delivery of global development programs with high quality and within allocated budget
• Strategic planning, resourcing, oversight of data deliverables including design and implementation of data capture tools, data processing, coding, validation, data quality and statistical programming
• Develops, implements and oversees an operational data ownership strategy in support of global development projects for all therapeutic areas
• Data standards development and adherence including guidance on data continuum; drives strategy to ensure compliance with CDISC standards for all development programs to ensure regulatory submission compliance
• Provide insight on latest technologies and changes in regulatory environments, enabling proactive approach and planning to meet future requirements and efficient study and data management support of global development programs
• Ensures the Clinical Data/statistical programming vendor's technology processes meet or exceed the regulatory requirements to support Schrodinger's global development projects
• Responsible for planning and management of external budgets related to data technology licensing, hosting and deliverables
• Technical oversight of other technologies (e.g. IRT, EDC, ECG, ePRO, etc.)

• Develop Clinical Data management documents for Schrodinger's clinical trials and execute data transfer plans for external data. Set up validated automated data flows and relays for data receipt through archive.
• Establish Clinical Data Solutions and science infrastructure, including the identification, set-up, testing and management of various electronic clinical trials data systems.
• Collaborate with internal and external stakeholders to ensure the quality and integrity of Clinical Data and data systems. Maintain a governance system to maintain acceptable levels of performance.

What you should have:

• Degree in Life Sciences/ Clinical Research (MS or higher).
• At least 12 years of clinical research and Clinical Data sciences experience (and early clinical development oncology) in both pharmaceutical and biotech environments, including 5+ years leading technical teams.
• Previous experience completing multiple complex clinical studies in oncology. Proven experience in the design, execution, and interpretation of first-in-human studies and proof-of-concept trials. Phase I-III experience preferred including IND and NDA filings.
• Experience in effectively managing CROs and other technical partners.
• Excellent leadership, communication, influencing and negotiating skills. Strong project management skills with demonstrated experience to manage multiple priorities while maintaining attention-to-detail, curiously solve complex problems and meet timelines.
• Expert knowledge in multiple vendor's clinical electronic data capture systems and other Clinical Data systems
• Experience leading multiple trials; leading global multidisciplinary trial teams in a complex matrix environment.
• Work well in cross functional team environment, both independently as well as be willing to help others
• Excellence working knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) Guidelines and other applicable regulatory regulations and guidelines.
• Familiarity with regulatory requirements for clinical development and submissions (e.g., FDA, EMA).
• Strong attention to detail and creative problem-solving skills are essential. Strong critical thinking skills and ability to work in a collaborative, fast-paced environment.
• Goal oriented, organized, capable of working on multiple projects, and able to execute to timelines that meet company goals
• Evidence of commitment to innovation and patient-centricity
• Ability to work independently and in a highly collaborative team environment
• Ability to travel (10% depending on project needs)

Pay and perks:
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 regular catered meals in the office, a company culture that is relaxed but engaged, and over a month of paid vacation time. Our Office Management team also plans 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 included in Crain's New York Best Places to Work, BuiltIn's NYC Best Place to Work, and Newsweek's list of America's 100 Most Loved Workplaces.
Estimated base salary range: $240,000 - $285,000. Actual compensation package is dependent on a number of factors, including, for example, experience, education, degrees held, market data, and business needs. If you have any questions regarding the compensation for this role, do not hesitate to reach out to a member of our Strategic Growth team.
Sound exciting? Apply today and join us!
As an equal opportunity employer, Schrödinger hires outstanding individuals into every position in the company. People who work with us have a high degree of engagement, a commitment to working effectively in teams, and a passion for the company's mission. We place the highest value on creating a safe environment where our employees can grow and contribute, and refuse to discriminate on the basis of race, color, religious belief, sex, age, disability, national origin, alienage or citizenship status, marital status, partnership status, caregiver status, sexual and reproductive health decisions, gender identity or expression, sexual orientation, or any other protected characteristic. To us, "diversity" isn't just a buzzword, but an important element of our core principles and key business practices. We believe that diverse companies innovate better and think more creatively than homogenous ones because they take into account a wide range of viewpoints. For us, greater diversity doesn't mean better headlines or public images - it means increased adaptability and profitability.