Site Management and Monitoring Hub Head (oncology)

AstraZeneca • Gaithersburg, MD

2d • $304,856 - $457,285

About The Position

AstraZeneca’s Site Management and Monitoring (SMM) organisation is responsible for global site management delivery across the Oncology portfolio. Reporting to the Global Head, SMM Oncology, the Oncology SMM Hub Leader provides expert input to global Therapy Area partners, translating the Oncology clinical development strategy into a regional clinical site and market operational plan. The role drives operational delivery excellence and oversees the timely, high-quality, ethical and compliant delivery of interventional trials across the USA and Canada. It is also accountable for maintaining and developing SMM frameworks that support AstraZeneca’s Oncology and Haematology portfolio.

The role leads regional strategy and operational excellence, aligning regional objectives with global SMM priorities and translating global strategy into market-level delivery. It establishes study leadership and monitoring practices, optimises digital strategies and ensures appropriate resources for SMM roles. The role drives cross-functional collaboration, implements outsourcing strategies, develops people and capabilities, and advances effective processes and systems for clinical trial conduct.

The Hub Leader manages budgets and resource forecasts, coordinates financial reporting, oversees regional contributions to global site operations metrics, ensures compliance with ICH/GCP and applicable CFR requirements, promotes continuous improvement and best-practice sharing, and leads opportunities for portfolio delivery and synergies across countries. The role hires, manages, develops and recognises direct reports.

Requirements

• Bachelor’s degree or equivalent qualification in a relevant scientific discipline.
• At least 10 years of relevant experience focused on Development and Patient Safety.
• Relevant experience in big pharma.
• Leadership experience in a complex environment.
• Ability to communicate effectively with stakeholders across AstraZeneca.
• Mastery of the Clinical Development area, with multidisciplinary experience across functions or within a functional area.

Nice To Haves

• PhD in a scientific discipline.
• Expert reputation within the business and industry, with extensive knowledge of the latest technical and regulatory expectations.
• Ability to engage, influence and collaborate across boundaries, with a strong problem-solving and delivery focus.
• Ability to assimilate sophisticated information, identify key issues and communicate clear messages.
• Functional management experience, including resource management, budget planning and functional planning.

Responsibilities

• Translate the global Oncology clinical development strategy into a regional clinical site and market operational plan for the USA and Canada.
• Oversee timely, high-quality, ethical and compliant delivery of interventional trials across the assigned region.
• Maintain and develop SMM frameworks supporting the Oncology and Haematology portfolio.
• Drive operational excellence across regional markets, using competitor intelligence, industry trends and best-in-class benchmarks to improve performance.
• Align regional objectives with global Site Management and Monitoring priorities and translate global strategy into market-level delivery.
• Identify and implement regional study leadership and monitoring practices aligned with Therapy Area needs.
• Optimise digital strategies and ensure appropriate resourcing for SMM roles at market level.
• Drive collaboration across market-level functions, including Medical Affairs, Regulatory, Payor and institutional partners.
• Lead outsourcing strategy implementation to establish efficient and flexible sourcing models.
• Build a strong people agenda and ensure the function and its people are trained, equipped and ready to deliver.
• Promote excellence across markets, Therapy Areas and geographies, and identify external trends that support effective deployment of skills, assets and technologies.
• Develop frameworks for innovative and effective ways of working with partners.
• Ensure excellence in the development and implementation of clinical trial processes and systems.
• Build, lead, forecast and update budgets; forecast resource requirements; and implement efficient country staffing systems and processes where needed.
• Coordinate financial reporting and ensure adherence to relevant procedures.
• Lead the regional SMM contribution to the global development site operations metrics dashboard and deliver against quality and speed metrics.
• Ensure compliance with ICH/GCP regulations and applicable CFR requirements.
• Contribute to continuous improvement of SMM operations and share best practices across regions, countries and departments.
• Identify and lead opportunities for portfolio delivery and synergies across countries in the region.
• Hire, manage, develop and recognise the performance of direct reports.

Benefits

• Short-term incentive bonus opportunity.
• Eligibility to participate in an equity-based long-term incentive program for salaried roles, or receive a retirement contribution for hourly roles.
• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Health benefits, including medical, prescription drug, dental and vision coverage, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior