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 and 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, coaches, builds, and encourages 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 our 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
The annual base pay for this position ranges from $200,578 to $300,867 and may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program.
Our 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. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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