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Senior Clinical Trial Manager/Associate Director, Clinical Operations

Cambridge, MA · Science/Research
Company Description

Rubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics™. Our proprietary RED PLATFORM® was designed to genetically engineer and culture Red Cell Therapeutics™ that are selective, potent and off-the-shelf allogeneic cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Our therapies can potentially be used to kill tumors in cancer and to regulate the immune system for the treatment of autoimmune diseases. Our IND for RTX-240, our first oncology candidate for the treatment of solid tumors, has been cleared by the FDA. Additionally, we plan to file an IND for RTX-321 for the treatment of HPV-positive tumors by year-end.

We are proud of our passionate, high-performance culture – one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2013, we are based in Cambridge, MA and currently expanding across all functions within the organization. Red blood cells are no longer just for carrying oxygen. Check us out at www.rubiustx.com, or follow us on Twitter and LinkedIn or like us on Facebook.

Job Summary

We are seeking an experienced clinical operations professional to join our growing Clinical Development Organization. This role will be key to leading the planning, execution and oversight of clinical trials in our Oncology program.  This position will also have the opportunity to help develop Clinical Operations processes and procedures for a growing department. Representing clinical operations on the program team, this role is responsible for adhering to timelines and milestones of study goals as well as identifying and communicating risks to the team.  

Responsibilities
  • Participates in authoring IND and study documents including protocols, IB, ICF pharmacy, lab and other study and program related manuals.
  • In partnership with regulatory affairs and quality, participates in global study submissions as well as oversight of additional resources needed (including QP readiness, document translations, etc.).
  • Representing clinical operations on the program team, provides overall status updates, escalates issues and presents on risk mitigation strategies to the cross-functional team
  • Lead in the selection and oversight of CROs and other vendors
  • Ensures appropriate oversight of CROs and other external vendors, including assessment of performance against contractual obligations
  • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
  • Develops close relationships with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress
  • Partners with Clinical Supply and Technical Operations to oversee drug supply of the applicable study drug(s).  This includes participating in long range supply planning for trials within the oncology program
  • Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)
  • Performs quality assurance checks (e.g. reviewing protocols for operational effectiveness, monitoring trip reports, conducting co-monitoring visits at clinical sites as needed, reviewing data listings or profiles at specified timepoints)
  • Demonstrates accountability for the management of assigned clinical study budget(s) through review of study-level scopes of work, invoices, and change orders in accordance with the evolving needs of the study
  • Anticipates, recognizes, and manages issues: exhibits the ability to recognize the need to seek assistance from or inform Senior Management of specific risks/issues; understands when decision making can occur at the study team level versus when there is a need for escalation to the program level or to Senior Management; applies appropriate preventative and corrective actions.
  • Drives quality efforts to proactively identify and manage risks to trial quality and ensure inspection readiness
Qualifications & Education
  • Bachelor’s degree (scientific or healthcare discipline preferred) plus at least 8+ years in clinical operations or drug development
  • Proven experience in the oversight of the operational aspects of all stages of clinical studies
  • Experience and familiarity with operating clinical trials outside the US
  • Extensive experience managing complex protocols
  • Prior experience managing Oncology trials
  • Experience with cell therapy will be favorably considered
  • Knowledge of ICH GCP
  • Excellent organizational as well as problem-solving skills as well as the ability to work independently
  • Ability to work in a fast pace, cross-functional, start-up environment
  • Ability and willingness to travel 10-15% of the time
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