Senior Director, Head of Country Operations

Wilmington, Delaware

This job has expired.

This is what you will do:
The Senior Director Head of Country Operations (SDHCO) will build and lead a local country team, fully accountable for country execution of clinical trials, all associated study deliverables, and quality within their country. The SDHCO is accountable for all committed operational trial deliverables, across programs, and all phases of development, completed according to timelines, operational procedures, quality standards, SOPs and guidelines. Focus is on high quality delivery in a time and cost effective manner, in accordance with local regulations and ICH/GCP guidelines.
The SDHCO is accountable and key contributor in the overall deliverables for the country, including early planning, feasibility, site selection, study start-up, enrollment, data deliverables, and close-out, and works in partnership with global stakeholders to define those deliverables.
SDHCO manages a large stand-alone country, and acts as National Head leading country operating model, managing multi-disciplinary teams, driving local strategies and managing stakeholders internal and external.
SDHCO has direct accountability for achieving operational excellence across assets in multiple research indications and complex operational environment through strategic and operational leadership.
The SDCH is accountable for line managing a dedicated group of staff, including direct line managers, and is accountable for planning and utilization of staff resources, assigned budget, objective setting, performance follow-up, and shaping processes and driving transformational change in fast evolving external landscape.
The SDHCO is a member of the Extended COM Leadership Team, and plays a central role in establishing and maintaining oversight and effective management of vendors including CROs and will create an effective communication pathway with other stakeholders within their country e.g. Local Medical Affairs and Legal (where applicable).
You will be responsible for:
• Leadership of large stand-alone country, driving high proportion of global patient contribution
• Ensuring resource optimization of team to deliver to committed clinical program targets, across all phases of development, and all TAs
• Directing country team to achieve quality and timeliness of all study deliverables (site identification, feasibility, start up, recruitment , data deliverables) within the respective country.
• Development and performance management of country team, and ensuring everyone in the team has development and training plans, according to company policy and people plans. Coaching team members and all direct and in-direct line reports on a regular basis
• Ensuring regular succession planning and talent development discussions
• Delivering country budgets to plan and agreed RBU targets
• Prepares salary and bonus proposals for all team members based on their performance, in close collaboration with RHCO and local HRBPs.
• Leading transformation within country infrastructure, shaping process and driving changes to ensure respective country contributes to effective COM organization
• Monitoring metrics and Key Performance Indicators (KPIs) across all studies in assigned country
• Ensuring cross-functional collaboration of team and Project Managers Country Operations (PMCOs) are proactively communicating with global study team members (Clinical Project Leads (CPL), and Study Leads Country Operations (SLCOs) to raise and resolve study specific blockers
• Partnering with Country Quality and Medical Advisor Pipeline/Medical Science Liaison to ensure quality, and Inspection Readiness, and management of site relationships, respectively.
• Contributes to high quality re/feasibility work, using data driven approach balanced with local intelligence to develop credible plans and country commitments for assigned projects.
• Approving Ethics Committee submissions and approvals
• Approving site selections for each study in assigned country
• Management of site relationships
• Ensure completeness and timeliness of the eTMF
• Ensuring that a post trial access plan is in place at the country level
• Compliance of local employees and contract workers (including FSP) with Alexion SOPs
• Proactively connecting with other SD/Head Country Operations to share issues and learnings to ensure overall success of COM organization
• Managing internal and external stakeholders, and driving local strategies within country and working in collaboration with local Medical Affairs, Regulatory, and AZ SMM colleagues
• Developing expertise in analyzing and resolving issues relating to study execution and compliance in fast evolving clinical trial landscape
• Ensuring that country operations teams are appropriately qualified and trained for the roles they undertake
• Driving continuous improvement and organizational performance monitored via global performance metrics ensuring high quality delivery
• Identifying performance issues and/or areas of opportunity for continuous improvement
• Minimum 10 years of clinical research experience with experience in the development & management of a clinical operations function and management of staff in a pharmaceutical and/or biotechnology environment
• Experience with internal delivery of global clinical trials. Proven excellence in operational strategy and delivery of clinical operations activities across multiple projects, including ability to translate the science to operational delivery
• Advanced people manager skills (direct and in-direct lines)
• Experience leading, developing and implementing functional and cross-functional teams, SOPs and processes
• Deep knowledge of global regulatory requirements and ICH/GCP guidelines
• Demonstrated proficiency in the implementation, monitoring and management of clinical trials
• Deep knowledge of Country environment for clinical trials and rare disease landscape
• Demonstrated ability to prioritize, meet deadlines, and manage competing priorities and changing demands
• Demonstrated ability to build, coach, mentor, motivate and supervise a high performing team in a dynamic company, including ability to clarify roles and responsibilities
• Enhanced ability to collaborate effectively cross-functional, and demonstrated influential and networking skills to establish excellent internal and external relationships, including alliance partners and vendors
• Demonstrated learning agility, change resilience, working in ambiguity, and growth mindset
• Strong planning and budgeting skills
• Superior written, oral and presentation skills
• Ability to lead in a matrix environment
• Portfolio management capabilities, including project management, operational and finance capabilities
• Excellent interpersonal skills across countries, cultures and organizational functions. Well-developed problem solving, organizational, and negotiating skills.
• Available for domestic and international travel up to 25%, dependent upon progress of programs
• Bachelor's level degree required.
Preferred Qualifications:
• International experience in role within Development Operations/ Clinical Research
• Previous field CRA experience
• Experience in running clinical studies for ultra-rare diseases and capability to develop and implement innovative solutions for optimizing the conduct of ultra-rare disease studies.
• Experience of adult and pediatric clinical research in various therapeutic areas.
• Masters or Doctoral degree or equivalent in a scientific discipline

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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