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About the position
The AD/Director, Clinical Operations (Oncology) will manage at least one oncology clinical trial under the leadership of the Head of Clinical Operations. This role will be responsible for overseeing the design and day-to-day execution of the clinical trial, ensuring timely completion and quality data, collaborating with clinical trial centers and investigators, management of trial timelines and budget, and management of vendors and CROs. This role will have regular interaction with senior management and will be expected to communicate with and foster effective relationships with internal and external stakeholders. This is an onsite/hybrid role based in Cambridge, MA.
Responsibilities
- Oversee the set-up, execution, and delivery of global clinical trial projects
- Work cross-functionally to coordinate the relevant and timeline exchange of information and materials to support clinical trial deliverables
- Set study goals, manage timelines, and oversee vendor deliverables
- Manage study budgets and track progress from start-up to close-out
- Assist in authoring of clinical trial protocols, investigator's brochures (IBs), informed consent forms (ICFs), clinical study reports (CSRs), and other clinical documents, as necessary
- Lead protocol implementation with vendors and sites, and ensure operational feasibility of the clinical trial
- Support the selection and management of investigators and clinical trial sites
- Collaborate and maintain strong relationships with CROs, vendors, and sites to ensure study deliverables are met and issues/risks are proactively identified and mitigated
- Support and manage oversight activities of all necessary vendors to ensure a high level of operational excellence is maintained
- Collaborate with CRO and sites to ensure the clinical study database is current, accurate, and routinely cleaned
- Support the clinical operations infrastructure build to maintain inspection readiness
- Line management responsibilities including hiring, performance management, career development, and mentorship
- Communicate program and trial updates, including risks and contingency plans, with senior management and key stakeholders regularly
Requirements
- 8+ years of clinical research experience with at least 5 years of industry experience (pharmaceutical or biotech)
- Minimum of 5 years of early (Phase 1-2) oncology drug development experience including experience supporting IND (CTA) submission activities. Experience in late-stage drug development is a plus.
- Knowledge of global clinical trial management in fast paced CRO outsourced environment with the ability to assemble a plan and execute on the details
- Excellent leadership skills and ability to lead, direct, and support cross-functional teams
- Ability to manage multiple priorities independently in a fast-paced environment
- Strong working knowledge of GCP/ICH and EU/EMA Guidelines for conducting clinical trials
- Bachelor's degree or equivalent in a scientific or healthcare discipline
- Anticipated travel up to 10-20%
