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AstraZeneca

Global pharmaceutical company developing prescription medicines

Director – Country Operations Management

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeBoston, MA, USA

About the Job

Requirements

  • A minimum of 7 years of clinical research experience, including experience developing and managing a clinical operations function and managing staff in a pharmaceutical or biotechnology environment.
  • Experience with internal delivery of global clinical trials and proven operational delivery of clinical operations activities across multiple projects.
  • Previous line management experience with direct reports.
  • Experience leading, developing, and implementing functional and cross-functional teams, standard operating procedures, and processes.
  • Deep knowledge of global regulatory requirements and ICH/GCP guidelines.
  • Demonstrated proficiency in implementing, monitoring, and managing clinical trials.
  • Deep knowledge of therapeutic-area operational delivery, the country clinical-trial environment, and the 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, including clarifying roles and responsibilities.
  • Ability to establish internal and external relationships, including with alliance partners and vendors.
  • Strong planning and budgeting skills.
  • Strong written, oral, and presentation skills.
  • Ability to lead in a matrix environment.
  • Project management and administrative skills.
  • Interpersonal skills across countries, cultures, and organizational functions, along with problem-solving, organizational, and negotiating skills.
  • Availability for domestic and international travel up to 25%, dependent on program progress.
  • A bachelor’s-level degree is required.

Responsibilities

  • Lead the local execution team for assigned programs in accordance with country-level ways of working.
  • Use available technology to manage local study delivery and identify opportunities for operational optimization.
  • Direct the country execution team to achieve quality and timely study deliverables, including site identification, feasibility, start-up, recruitment, and data deliverables.
  • Optimize assigned team resources to deliver committed clinical program targets.
  • Develop and performance-manage direct reports, ensure each has development and training plans consistent with company policy and people plans, and provide regular hands-on support and coaching.
  • Participate in succession planning and talent development discussions.
  • Prepare salary and bonus proposals for direct reports based on performance, in consultation with the SDHCO and local human resources business partners.
  • Contribute to transformation initiatives, shape processes that standardize country-level ways of working, and manage change to support an effective COM organization.
  • Monitor metrics and key performance indicators across all studies.
  • Ensure cross-functional collaboration between the team, PMCOs, global study team members, and local study team members; proactively communicate to raise and resolve study-specific blockers.
  • Partner with Development Country Quality and the Medical Advisor Pipeline to support a quality mindset, inspection readiness, and site engagement.
  • Contribute to high-quality feasibility work using data and local intelligence to develop credible plans and country commitments aligned with country goals.
  • Oversee local team member interactions with institutional review boards and ethics committees.
  • Approve site selections for each study.
  • Ensure the electronic trial master file is complete on time.
  • Ensure a post-trial access plan is in place as part of study completion.
  • Ensure local study teams and contract workers, including functional service providers, comply with Alexion standard operating procedures.
  • Connect proactively with other country leaders to share issues and learnings for the success of the COM organization.
  • Manage internal and external stakeholders and support local country strategies in collaboration with local Medical Affairs, Regulatory, and AZ SMM colleagues.
  • Manage country- and local-study-level risks, issues, and decisions, escalating to the SDHCO as appropriate.
  • Develop expertise in analyzing and resolving issues related to study execution and compliance in the evolving clinical-trial landscape.
  • Ensure execution teams are appropriately qualified and trained for their roles.
  • Drive continuous improvement and team performance using global, regional, and country performance metrics to ensure high-quality delivery.
  • Identify performance issues and opportunities for continuous improvement.

Desired Qualifications

  • Previous field clinical research associate experience.
  • Experience running clinical studies for ultra-rare diseases and developing and implementing innovative solutions to optimize the conduct of ultra-rare disease studies.
  • Experience in adult and pediatric clinical research across various therapeutic areas in the United States.
  • A master’s or doctoral degree, or equivalent, in a scientific discipline.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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