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Sr. Director, Clinical Operations
at Akebia Therapeutics
Reporting to the VP, Clinical Operations, the successful candidate will direct therapeutically focused teams and oversee clinical program(s) including development plan strategy, clinical trial design and execution (in patient Phase 1-4 and post-marketing regulatory studies). Establish consistent clinical research practices, and ensure regulatory compliance across assigned Global Project Teams. In conjunction with the VP, Clinical Operations and with cross-functional project team members, the Sr. Director, Clinical Operations is accountable for successful delivery of all programs. The Sr. Director of Clinical Operations must have experience managing and providing oversight of clinical programs and be able to effectively manage interactions across functions third party providers, and investigators/advisors/thought leaders. The individual will be responsible for management of budgets, timelines and resources for clinical development program(s) and may provide oversight to other staff and functions.
- Provide therapeutically focused support and oversight to staff for development and optimization of global clinical strategy and processes, including effective delegation to direct reports to meet program goals.
- Support VP, Clinical Operations with implementation of initiatives, serve as liaison / change management champion for Clinical Operations
- Proactively work with clinical teams to develop and assure effective implementation of compound development and study execution plans. Facilitate problem solving and conflict resolution with internal and external stakeholders to prospectively reduce issues / remove roadblocks and keep teams on track with key deliverables across the compound(s).
- Responsible and accountable for ensuring accurate and up-to-date study and program information within relevant tracking systems and providing regular updates; proactively identify, risk-manage and resolve issues that arise during study and program conduct; manage escalation of study and program - related issues.Oversee development of budgets and timelines for Program(s). Work with study team(s) to ensure accurate forecasting, tracking, timely review of study budgets. Facilitate timely escalation of variances within established processes.
- Translates corporate and product development goals into relevant, tangible and measurable objectives for the operational team and third party vendors and drives optimal delivery.
- Oversee and ensure development of accurate program and study level plans. Actively contribute to the Global Project Team, supporting the strategic planning and execution of clinical development plans, including all governance processes, external consultants, and partnering activities.
- Accountable for management of all clinical research activities including proactive identification of work streams and dependencies, key risk indicators, resources and milestones
- Interpersonal Skills – Strong interpersonal and project management skills.
- Communication Skills- Excellent oral, written communication, and presentation skills utilizing all available technologies.
- Productivity/Organizing/Planning –Must be proactive and self-disciplined and meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Collaboration & Teamwork– Advanced competence in collaboration and teamwork.
- Relationship Management– Must be able to manage the relationship with CROs and other service providers that includes clinical study site staff, such as investigators, study coordinators, pharmacists, as well as other relevant functional team members.
- BS Degree in science or a health related field is required.
- Must have at least 15 years of direct clinical trial management experience
- Must have multi-trial, Phase 2/3, global experience in a leadership role.
- Must be able to travel up to 25%.
- Detail oriented and good problem solving ability.
- Ability to work on teams and with multiple projects, and works well under general direction.
- Working knowledge of medical terminology.
- Excellent computer skills.
- Excellent knowledge of GCP, ICH and FDA regulations.
- Ability to provide appropriate leadership to clinical sites and team members as appropriate
- Independently motivated.