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Director/Senior Director, Clinical Operations - Cambridge, United States - Schrödinger
Description
Schrödinger is revolutionizing drug discovery through the use of breakthrough computational methods that are advancing internal programs into the clinic.
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.
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
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 teamsResponsible 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)
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 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.
Estimated base salary range:
$220,000 - $290,000 (NYC only). 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.#J-18808-Ljbffr
