Clinical Operations Director/Senior Director

Location
New York, NY, United States
Posted
Apr 15, 2021
Ref
4315641003
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
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/Senior Director to join the NYC-based Early Clinical Development team. This hire will oversee study management activities, budgets, and contracts for Schrödinger's clinical assets and report to the Head of Early Clinical Development. 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 drug developers working within therapeutically agonistic indications. The group applies our proprietary physics-based drug design and optimization platform to the drug discovery process, which has successfully advanced ten programs into preclinical development, four programs into clinical development, and one to an FDA approval.

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 CRO 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 manage cross-functional team resources, external service providers (vendors, CROs, etc) and clinical sites to conduct trials on time, on budget, and in compliance
  • Ensure compliance training for clinical trial teams and sites
  • Take responsibility for writing, reviewing, and/or approving clinical project deliverables, such as investigational product labeling, pharmacy manuals, PK manuals, informed consent, IRB submissions/approvals, site activations, monitoring plans, CRFs, DMP, edit checks, safety plans, DMC charter, close-out plans, and CSRs
  • Identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient recruitment strategies to deliver enrollment targets
  • Oversee site monitoring activities
  • Ensure that all TMF-related documentation is current and on-file
  • Prepare teams for regulatory agency audits and address any audit observations appropriately
  • Proactively monitor and report trial progress and performance, timelines, and financial metrics on an ongoing basis
  • 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 domestic clinical trials (experience with early development oncology - i.e., Phase 1 oncology trials is strongly preferred)
  • Excellent project management skills with an ability to manage multiple priorities while maintaining attention to detail
  • 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.

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, or sexual orientation. 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.