Join to apply for the Director of Clinical Operations role at EpiBiologics
Join to apply for the Director of Clinical Operations role at EpiBiologics
This range is provided by EpiBiologics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$202,500.00/yr - $247,500.00/yr
The Director of Clinical Operations will provide strategic leadership in support of our clinical development vision and manage and execute one or more first in human phase I-II global clinical trials.
Description
The ideal candidate must be able to manage all clinical operational aspects of one or more clinical trials. Experience in Early Phase clinical trial management is preferred, including study start-up activities, patient enrollment initiatives, study maintenance, and close-out. The applicant must be attentive to detail and able to contribute to writing study protocols, informed consent forms, study manuals, develop SOPs, etc. We are seeking an experienced leader capable of providing strategic insights and technical expertise while navigating a complex global clinical trial landscape. The candidate must maintain a balance between ensuring the highest quality standards and driving the vision for our platform under aggressive timelines.
ESSENTIAL JOB FUNCTIONS:
- Provide leadership and oversight in all aspects of clinical operations, from planning and executing programs to project oversight
- Provide strategic operational input to Clinical Development Plan (CDP) and project plans
- Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics, timelines, and critical study activities
- Creating and overseeing clinical trial budget
- Develop and maintain enrollment forecasts
- Identifying, assessing, and selecting study sites/PIs in partnership with CMO and Vendors (as applicable)
- Manage CROs and third-party vendors to ensure delivery against the contracted scope of work and budget
- Assist in executing and managing legal contracts from clinical sites, vendors, etc., in conjunction with outside legal counsel
- Participate in selecting CRO and vendors, including developing RFPs, budget negotiations, and management
- Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA, and contribute to IND filings
- Develop and assure compliance with SOPs, local regulations, and CFR, ICH, and GCP guidelines.
- Ensure development study plans and provide adequate oversight for vendor oversight, risk, safety, and communication
- Ensure ongoing TMF and data collection are on track and maintaining quality
- Drive & support preparation for data cleaning and cuts
- Study specific participation in system set-up for key systems (e.g., IVRS, EDC, TMF, other)
- Plan and oversee Investigator Meetings as applicable
- Provide supervision, coaching, and mentoring and contribute to hiring new staff.
- Ensuring cross-functional team project-specific training
- Hosting, documenting, and filing internal /external project team meetings
- Assess project risk through life of project and escalate/ problem solve as needed
- Proactively identify risks and develop and implement mitigation strategies
- Self-motivated and able to thrive in a fast-paced, start-up environment
- Plan, participate, and facilitate operational-level governance with vendors as appropriate
- Ensure timely and effective risk mitigation and escalation for projects and programs
- Provide senior executive management with project and program updates
- Leads collaborative teams for projects or groups both internal and external to business and across functional areas. Reacts well under pressure.
Other Duties
- Travel to client or prospective locations, conferences, or other professional development and networking events
- Attend staff, departmental, and other required meetings and trainings
- Partner with cross-functional peers & staff to build execution plans & meet critical business milestones
- Able to travel (