Clinical Program Director (Cell Therapy Clinical Operations)

AstraZeneca • Gaithersburg, MD

90d • $200,578 - $300,867

About The Position

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 and a diverse range of departments both within and outside of AstraZeneca.

Requirements

• Bachelor's degree in related field 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.

Nice To Haves

• 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.

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.

Benefits

• A qualified retirement program [401(k) plan].
• Paid vacation, holidays, and paid leaves.
• Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
• Short-term incentive bonus opportunity.
• Eligibility to participate in equity-based long-term incentive program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree