Director, Country Operations Management

About this role

Location: Boston, Seaport  

Hybrid: 60% onsite   

The Director Country Operations Management (DCOM) will lead a local execution team, fully accountable for all study deliverables and quality for programs in their country).  The DCOM is accountable for execution of all assigned operational trial deliverables, for assigned programs completed according to timelines, operational procedures, quality standards, SOPs and guidelines. Focus is on high quality delivery in a timely and cost-effective manner, in accordance with local regulations and ICH/GCP guidelines, and as aligned with country level ways of working.

The DCOM is a 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 study team, SDHCO, Dir SSU and Site Partnership, and RHCO to define those deliverables. DCOM is accountable for leading, managing, training, and developing a dedicated team of direct reports, and is responsible for planning and optimization of reporting resources including objective setting, performance follow-up, and contributes to shaping processes to standardize ways of working country level and managing change .

The DCOM will play a central role in 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: • Leads local execution team for assigned programs consistent with country level ways of working

• Utilize available technology proficiently to manage local study delivery and identify opportunity for operational optimization

• Directing country execution team to achieve quality and timeliness of all study deliverables (site identification, feasibility, start up, recruitment, data deliverables).

• Ensuring resource optimization of assigned team to deliver to committed clinical program targets.

• Development and performance management of direct reports and ensuring each direct report has development and training plans according to company policy and people plans. Hands-on support and coaching direct line reports on a regular basis to address challenges and needs

• Participate in succession planning and talent development discussions

• Prepares salary and bonus proposals for direct reports based on their performance, in close consultation with SDHCO and local HRBPs.

• Contributing to transformation initiatives, shaping processes to standardize ways of working country level, and manages change to ensure contribution to effective COM organization

• Accountable for monitoring metrics and Key Performance Indicators (KPIs) across all studies

• Ensuring cross-functional collaboration of team and PMCOs through proactive communication with global study team members (Global Study Directors, Global Study Associate Directors, Global Study Managers), and other local study team members (Study Start-up Managers, Site Contract Associate Directors, Site Alliance Lead, Site Solutions Manager, CRAs, and ADCOM) to raise and resolve study specific blockers quickly

• Partnering with Development Country Quality and Medical Advisor Pipeline to ensure quality mindset, and Inspection Readiness, and management of site engagement, respectively.

• Contributes to high quality re/feasibility work, using data driven approach balanced with local intelligence and site insights to develop credible plans and country commitments for assigned projects, and in accordance with country goals.

• Overseeing local team member interactions with IRB/Ethics Committees

• Approving site selections for each study

• Ensure timely completeness a of the eTMF

• Ensuring that a post-trial access plan is in place as part of study completion

• Compliance of local study team and contract workers (including FSP) with Alexion SOPs

• Proactively connecting with other Country leaders to share issues and learnings to ensure overall success of COM organization

• Managing internal and external stakeholders, and supporting local strategies within country and working in collaboration with local Medical Affairs, Regulatory, and AZ SMM colleagues

• Effectively manages risks, issues, decisions at the country and local study level; escalates to SD HCO appropriately

• Developing expertise in analyzing and resolving issues relating to study execution and compliance in fast evolving clinical trial landscape

• Ensuring that respective execution teams are appropriately qualified and trained for the roles they undertake

• Driving continuous improvement and team performance monitored via global, regional and country performance metrics ensuring high quality delivery

• Identifying performance issues and/or areas of opportunity for continuous improvement

Qualifications: • Minimum 7 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 delivery of clinical operations activities across multiple projects

• Previous line management experience (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 respective TA operational delivery, 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, includ

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