Local Feasibility Lead - Cell Therapy

AstraZeneca

3d • $137,938 - $206,906 • Remote

About The Position

The United States Local Feasibility Lead, Cell Therapy is part of the country structure of the Cell Therapy Site Management & Monitoring (SMM) organization and is responsible for supporting the feasibility assessment and delivery of the early and late-development Cell Therapy Portfolio. The Local Feasibility Lead works in close collaboration with the CTCO Associate Director Regional Feasibility, SMM country teams, and key stakeholders within CTCO and wider Cell Therapy R&D teams to ensure that feasibility commitments are achieved in a timely and efficient manner. The Local Feasibility Lead acts as the single point of contact for all stages of local feasibility assessment operations and is responsible for supporting quality decision-making through standardized tools, processes, and strategic feasibility planning. The role sits within CTCO SMM within the country team and reports to the Director Feasibility, Cell Therapy. The Local Feasibility Lead also represents SM&M in various cross-functional optimization and engagement workstreams. This is a field-based position. The Local Feasibility Lead is responsible for leading end-to-end country feasibility activities for AstraZeneca internally delivered Cell Therapy studies, including development of local recruitment and retention feasibility strategies, country/site allocation planning, recruitment forecasting, and feasibility assessment operations. The role serves as the country Subject Matter Expert for feasibility and recruitment and works closely with SMM Leadership Teams, Site Partnerships, Medical Affairs, and Global Feasibility teams to support predictable study delivery and effective operational planning.

Requirements

• Bachelor’s degree in a relevant field such as Life Sciences, Business Management, or Project Management, or equivalent project management certification.
• Significant experience (~5 years) within pharmaceutical industry drug development processes.
• Proven experience managing stakeholder relationships and influencing senior stakeholders within complex and conflicting priority environments.
• Experience developing and delivering study delivery strategies and operational plans aligned with commercial and regulatory objectives.
• Experience with clinical trial patient and investigator recruitment and retention activities.
• Proven project and budget management experience.
• Excellent written and verbal communication, negotiation, collaboration, and interpersonal skills.
• Excellent knowledge of ICH/GCP guidelines and basic knowledge of GMP/GDP requirements.
• Good knowledge of relevant local regulations and clinical development processes.
• Good understanding of Clinical Study Management, including monitoring, study drug handling, and data management.
• Strong analytical, problem-solving, and organizational skills.
• Ability to work effectively within remote and cross-functional teams.
• Ability to travel approximately 15% as required.
• Ability to prioritize and manage multiple competing deadlines effectively.
• Good cultural awareness and adaptability within global organizations.
• Ability to identify and champion more efficient and effective methods for delivering quality clinical trials.

Nice To Haves

• Experience in new product development within the pharmaceutical industry.
• Prior experience developing study delivery strategies aligned with local regulatory objectives.
• Proven project management or cross-border management experience.
• Experience working with Clinical Research Organizations (CROs) and Academic Research Organizations (AROs).
• Experience in Cell Therapy preferred.
• Ability to influence strategically and persuade tactfully while maintaining positive organizational relationships.
• Process innovation mindset with the ability to evaluate workflows and identify opportunities for operational efficiency and innovation.
• Ability to work effectively in technology-enabled and data-driven environments.
• Team-oriented, flexible, and responsive to shifting priorities and business needs.

Responsibilities

• Accountable to Senior Director Feasibility Cell Therapy who sets the Feasibility Strategy Globally from design feasibility through operational feasibility and study baseline/re-baseline.
• Leads end-to-end country feasibility assessment activities and acts as the single point of contact for local feasibility operations.
• Supports study design validation by identifying country-specific operational and recruitment challenges.
• Identifies conflicts with clinical standard of care and provides transparency regarding delivery risks identified through investigator feasibility responses and competitive landscape assessments.
• Partners with Medical Affairs and key stakeholders to support targeted competitive landscape and recruitment trend discussions.
• Leverages AstraZeneca and competitor performance data to develop realistic and cost-efficient recruitment targets and strategies.
• Provides transparency regarding recruitment approaches, including use of recruitment vendors, site identification vendors, and site-specific recruitment tools.
• Collaborates with SMM Leadership Teams, Site Partnerships, Field Clinical Advisers, and Medical Affairs to provide country-level feasibility feedback and operational recommendations.
• Supports early country planning activities by identifying and sharing pipeline information and project updates with SMM Leadership Teams.
• Manages, validates, and delivers country SMM feasibility responses within planned timelines and quality expectations.
• Supports achievement of study planned milestones, Patient Recruitment Framework recommendations, and Global Medicines Development recruitment objectives.
• Leads development of country-specific and site-specific recruitment and retention strategies aligned with feasibility findings and operational requirements.
• Collaborates with LSADs, CRAs, and SMM Leadership Teams to contribute to study-specific risk management, mitigation planning, contingency planning, and escalation activities.
• Ensures effective transfer of country-specific feasibility knowledge to Local Study Teams during handover meetings.
• Supports global and local process improvement and simplification initiatives related to feasibility, recruitment, and retention activities.
• Maintains awareness of marketplace activities, technology, recruitment trends, policies, and operational practices impacting clinical trial delivery.
• Champions recruitment and retention best practices and supports knowledge sharing and process improvement initiatives within Clinical Operations.
• Participates in training and mentoring of local study team members while ensuring compliance with ICH/GCP guidelines and AstraZeneca procedural documents.
• Ensures compliance with company policies, local regulations, and applicable clinical development standards.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

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