- Responsible and accountable for planning and execution of clinical projects: oversight and directional alignment of timelines, budget, and key deliverables as well as contributing to overall clinical strategy.
- Responsible for Clinical Operations functional, oversight of clinical operations staff including contractors and employees. Accountable for ensuring clinical trials are executed to corporate timelines and within agreed budget, including management of project budget, forecasting and long-range planning.
- Set operational performance goals, key performance indicators and targets.
- Provide input in development of clinical plans, detailed study plans, synopses, and protocols
- Responsible for outsourcing strategy including strategic partnerships/preferred relationships with CROs, vendors, investigators, and other external partners.
- Provide oversight and vendor management of all clinical vendors
- Provide leadership and support to Study Start-up: responsible for overseeing all clinical start-up activities including feasibility, site selection/recommendation, budget & timeline planning, supply chain, and regulatory preparation.
- Develop and implement robust risk identification and mitigation plans to solve complex issues that impact study or program milestones.
- Develops strong, collaborative working relationships with CROs/vendors, key investigators, and other key staff/vendors.
- Partners with CROs and cross-function teams to facilitate site engagement and recruitment activities. Ensure site training/communications are occurring as needed.
- Oversee clinical systems and technical integrations for databases, CTMS, eTMF, central reading, and other trial execution and/or data collection platforms.
- Be responsible for overall quality management systems for Clinical Operations including quality oversight, vendor oversight, SOP systems, training, documentation, and GCP compliance.
- Manage clinical site preparation activities in coordination with the selected CRO
- Establish relationship with study site personnel to keep track of patient enrollment and treatment schedules. Ensure patient follow-ups for clinical results are received in timely manner
- Bachelor's Degree in life sciences
- Strong people and project management skills
- Minimum of 15+ years of clinical operations experience in a pharmaceutical, biotech, or CRO setting
- Experience in Immunology drug development; experience with Inflammatory Bowel Disease (IBD) is a plus
- Experience in working in an outsourced model, including overseeing CROs and other vendors
- Trial execution experience from Phase 1 through Phase 3. Experience in Immunology drug development is a plus.
- Excellent leadership skills and ability to lead, direct and support cross-functional teams
- Strong interpersonal, organizational, and multi-tasking skills
- Excellent knowledge and understanding of GCP/ICH and EU Guidelines for conducting clinical trials, and have inspection experience
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Clinical Operations Development Leader - Boston, United States - Odyssey Therapeutics
4 weeks ago
Description
About UsOdyssey Therapeutics is propelling drug development beyond what is now possible to deliver medicines that address critical needs of patients with inflammatory diseases and cancer. We achieve unprecedented speed and efficiency by bringing together a target-centric approach, a toolbox of cutting-edge technologies, and a team of accomplished, world-class drug hunters. By reimagining the drug development process, we are creating a deep and broad drug pipeline that holds the potential to transform human health.
Position Details
Job Title: Clinical Operations Development LeaderLocation: Boston, MA
Employment Type: Full-Time, Hybrid
Department: Clinical Development
The Opportunity
We are currently looking for a Clinical Operations Development Leader to partner with the CMO to build clinical development during a phase of rapid clinical expansion.
You will support operations of regional and global trials with minimal supervision in a small fast-paced company environment. You are a seasoned clinical operations leader who is comfortable working independently and experienced managing cross-functional activities internally and externally. As an integral senior member of the Odyssey Clinical and Translational Development team, you possess strong skills for internal leadership and coordination as well as external vendor management with deep experience in selection and management of full-service CROs and other contracted partners.
You will be responsible for leadership and oversight of all clinical trial activities including vendor oversight and management, from Study Start-up thorough execution and close out of all clinical trials within assigned programs supporting Clinical Development within the R&D organization. This position will report directly to the Chief Medical Officer with grading commensurate with experience.
Key Responsibilities
