- In collaboration with Cell Therapy leadership, is accountable for the clinical program strategy, including innovative ways to delivery, e.g., new delivery platforms and technology to ensure patient engagement, recruitment, and retention.
- Plans, advises, and delivers 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 KPIs
- Leads and delivers differentiated and robust operational options for review at Investment Decision Governance interactions
- Leads 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, etc., to ensure seamless delivery of programs through effective collaboration.
- Responsible for the quality of study delivery planning information into relevant planning systems
- Accountable for ensuring timely 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 as well as statistics and regulatory in order to craft and deliver robust clinical development plans.
- Develops, coaches, mentors, builds, and encourages individuals within the organization.
- Bachelor's degree in related discipline, preferably in medical or biological science.
- At least 10 years of proven experience.
- Extensive knowledge of the clinical and pharmaceutical drug development process
- Proven track record to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements
- Significant experience of program management and use of project management techniques in sophisticated projects, including resourcing and financial management
- Significant experience and expertise in Clinical Trial methodology with a proven ability to deliver differentiated options based on a sound knowledge of operational delivery
- Proven track record in problem solving and issues management that is solution focused
- Proven experience of leading delivery through collaboration with internal and external providers
- Excellent knowledge of ICH-GCP principles
- Experience in selection of external providers and development/review of contracts
- Proven oversight of external providers
- Higher degree e.g. PhD, MSc, MPhil
- Program management qualification (e.g. MBA, PRINCE2, PMP)
- Experience in variety of academic/CRO/Sponsor organisations 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
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Clinical Program Director-Cell Therapy, Early Oncology Clinical - Watertown, United States - AstraZeneca
Description
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. We have a bold ambition to provide cures for cancer in every form. We are following the science to understand cancer and all its complexities to discover, develop and deliver life-changing treatments and increase the potential to save the lives of people around the world. Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us.
One of our core values is 'Follow the science' - something that guides our decision-making at every level. It is up to each of us to keep pushing forward and pioneer new approaches. From bold innovations and integrated healthcare systems to harnessing data and technology.
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 strong collaborative communication skills, including the ability to engage with and influence a diverse range of departments both within and outside of AstraZeneca.
Job Responsibilities
Minimum Qualifications
Desirable Experience
As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move from Waltham to Kendall Square/Cambridge in 2026. Find out more information here:
Kendall Square Press Release
So, what's next:
Imagining yourself joining our team? Join us to be part of building an innovative pipeline and deliver potentially high impact treatments to patients. Submit an application today
Find out more:
Our Social Media, Follow AstraZeneca on LinkedIn
Follow AstraZeneca on Facebook
Follow AstraZeneca on Instagram
Date Posted
18-Apr-2024Closing Date
17-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.&v=024){kind=logo}
