Clinical Program Director

The Clinical Program Director (CPD)-Cell Therapy has an impactful role, including responsibilities for the clinical program strategy and operational design inputs to deliver their assigned program(s). Within a program, they maintain accountability for the delivery and reporting of clinical studies to time, quality, and cost.

The CPD is a leadership member of the Global Project Team. This opportunity requires skills, including the ability to engage with a diverse range of departments both within and outside of AstraZeneca.

Job Responsibilities

• In collaboration with Cell Therapy leadership, is accountable for the clinical program strategy, including ways to delivery, e.g., new delivery platforms and technology to ensure patient engagement, recruitment, and retention.
• Plan, advise, and deliver the operational components of assigned clinical programs from design concept to final CSR, through to study closed and archived within agreed budget, time, quality and aligned Goals.
• Lead and deliver unique operational options for review at Investment Decision Governance interactions.
• Lead operational discussions with external entities including regulatory agencies, preferred partners/suppliers, and external collaborators.
• Provide expert clinical operational input into: Target Product Profile (TPP), Clinical Development Plan (CDP), Study Synopsis, Clinical Study Protocol, Clinical Study Report, IB, briefing documents to ensure seamless delivery of programs through collaboration.
• Responsible for the quality of study delivery planning information into relevant planning systems.
• Ensure compliance with company-wide governance controls (e.g., Delegations of Authority, study attestations, Letter of Assurance, financial system access, Clinical Trial Disclosure).
• Review and operational approval of program/study specific contracts or work orders.
• Operational management and oversight of external providers.
• Engagement with preclinical and translational science and statistics and regulatory to create clinical development plans.
• Develop, coach, build, and encourage individuals.

Minimum Qualifications

• Bachelor's degree in related discipline in medical or biological science.
• A minimum of 10 years of demonstrated experience.
• Knowledge of the clinical and pharmaceutical drug development process.
• Track record to develop programs to meet our goals and to assess our risk versus potential value; ability to understand global requirements.
• Experience of program management and use of project management techniques in projects, including resourcing and financial management.
• Experience in Clinical Trial methodology creative options based on a sound knowledge of operational delivery.
• Experience leading delivery through collaboration with internal and external providers.
• Excellent knowledge of ICH-GCP principles.
• Experience in selection of external providers and development of contracts.
• Oversight of external providers.

Desirable Experience

• Higher degree e.g. PhD, MSc, MPhil.
• Program management qualification (e.g. MBA, PRINCE2, PMP).
• Experience in variety of academic/CRO/Sponsor organizations and countries.
• Experience across the product life cycle and multiple therapeutic areas.
• Experience of early phase clinical delivery.
• At least 5 years global drug development experience within clinical function.