AstraZeneca
Cell Therapy
LocalFeasibilityLead-CellTherapy
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“Local Feasibility Lead - Cell Therapy at AstraZeneca. Skills: Feasibility assessment, Recruitment strategies, Operational planning, Stakeholder management. Lead end-to-end country feasibility assessment activities.. Act as single point of contact for local feasibility operations.”
What You'll Achieve.
Ensure that feasibility commitments are achieved in a timely and efficient manner.; Support quality decision-making through standardized tools, processes, and strategic feasibility planning.; Support predictable study delivery and effective operational planning.; Support achievement of study planned milestones, Patient Recruitment Framework recommendations, and Global Medicines Development recruitment objectives.
Industry & Context.
analytical, problem-solving, and organizational skills.
Field-based position., Ability to travel approximately 15% as required.
What They're Looking For.
Must Have
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., 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 Have
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.
What You'll Do.
Lead end-to-end country feasibility assessment activities.
Act as single point of contact for local feasibility operations.
Support study design validation by identifying country-specific challenges.
Identify conflicts with clinical standard of care.
Provide transparency regarding delivery risks.
Partner with Medical Affairs and key stakeholders.
Leverage performance data to develop recruitment targets.
Provide transparency regarding recruitment approaches.
Collaborate with SMM Leadership Teams
Field Clinical Advisers
Support early country planning activities by sharing pipeline information.
and deliver country SMM feasibility responses.
Support achievement of study planned milestones.
Lead development of country-specific and site-specific recruitment and retention strategies.
Collaborate with LSADs
and SMM Leadership Teams to contribute to risk management.
Ensure effective transfer of country-specific feasibility knowledge.
Support global and local process improvement initiatives.
Maintain awareness of marketplace activities
and operational practices.
Champion recruitment and retention best practices.
Participate in training and mentoring of local study team members.
Ensure compliance with company policies
and applicable clinical development standards.
How You'll Work.
Team & Collaboration
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.; Represents SM&M in various cross-functional optimization and engagement workstreams.; Works closely with SMM Leadership Teams, Site Partnerships, Medical Affairs, and Global Feasibility teams.; Collaborates with SMM Leadership Teams, Site Partnerships, Field Clinical Advisers, and Medical Affairs.; Collaborates with LSADs, CRAs, and SMM Leadership Teams.; Ensures effective transfer of country-specific feasibility knowledge to Local Study Teams during handover meetings.; Ability to work effectively within remote and cross-functional teams.
Communication Scope
Excellent written and verbal communication; negotiation; collaboration; interpersonal skills
Process & Methodology
Proven project and budget management experience., Proven project management or cross-border management experience.
Full Job Description
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. **_Typical Accountabilities:_** * 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
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