Location: Boston MA
Job Type: Contract
- The Director, Clinical Project Lead is responsible for 1) strategic oversight and operational accountability of a financially robust clinical development program and/or 2) direct report management of resources (e.g., Clinical Project Leads).
- The Director may be a member of the program’ s Core Team and as such, will ensure alignment and accountability with other Clinical Development functions for operational activities according to quality, schedule and cost standards set by the Global Development Plan (GDP), SOPs and GCP. As a direct report manager, the Director will manage clinical operations resources (e.g., CPLs) in the operational conduct of clinical studies.
- Accountable for the implementation and execution of a high priority Clinical Development Plan, including all clinical trials under the Program. Member of the Core Team, in representation of Clinical Operations. Leads and provides oversight to Senior Manager CPL and Associate Director CPL assigned to related Program. Ensures consistency across all studies within the Program. Reports to the Head CPL on changes in the Development Plan, Program metrics, issues, and rescue activities. Directly accountable and responsible for the planning, implementation and execution of pivotal, high corporate priority, key clinical trials.
- Depending on the program scope, the director may still have direct study management responsibilities similar to any other CPL.
- Leads an Extended Global Clinical Operations Team, as program scope requires.
- Contributes strategic and operational assessment (i.e., risk management/feasibility assessment) to the development of the Global Development Plan (GDP).
- Accountable to GDT Leader for planning, tracking and forecasting the Global Clinical Operations budget, resources (allocation) and timelines for the program against the agreed goals.
- Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.
- Collaborates with the appropriate Functions in defining the outsourcing strategy for the development programs.
- Establishes the operational standards for the program (e.g., monitoring plans, risk mitigation strategy, and oversight of operational vendors (e.g., monitoring, labs, imaging, etc.).
- Review all key deliverables (e.g., Protocol, ICF, www.clincaltrials.gov posting, CSR, etc ) for consistency across program. Ensure full compliance with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and EU Clinical Trial Directive throughout the entire clinical development plan. Develop in-depth knowledge of the clinical data and assure appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence.
- Provides input to Program & Portfolio Management, in case of project prioritization exercises within the portfolio.
- Lead or contribute to the GCO functional excellence efforts and initiatives, which affect cross- functional processes, as requested.
- > 12 years of clinical research experience, 8 of which in leading roles accountable for the planning, execution and reporting of global clinical trials of diverse development phases (I – IV)
- Bachelor’ s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
- Ability to lead cross-functional teams and to represent clinical operations in Core - Product Development Teams. Solid understanding of integrated development process for pharmaceuticals products.
- Leadership, project management, resource management are required.
- Advanced degree (Master, PhD, MD) is highly desirable.
- PMP certification desirable.
- Extensive experience for financial oversight of a global clinical development program is desirable.
- Line management experience is desirable.