Senior Director Clinical Programs
Cambridge - UK
Gaithersburg - US
Do you have expertise in, and a passion for, Early Oncology Clinical Operations? Would you like to apply your expertise to impact the lives of patients living with cancer, in a company that follows the science and turns ideas into life changing medicines, Then AstraZeneca might be the one for you!
About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation 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. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.
Pioneers of collaborative research we have built an unrivalled scientific community both internally and externally. Fusing academia and industry, we have united some of the world’s foremost medical centres. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers.
Our pioneering approach and breakthroughs from studies have enabled us to lead integrated healthcare systems to rethink the way we work. From cancer charities to the NHS, leaders across the industry are requesting to partner with us.
Site Description Welcome to Cambridge, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you.
Where Science thrives…Cambridge is one of the most exciting bioscience hotspots in the world, playing a central role in our mission to deliver life changing medicines to patients across the globe.
This role could be located in either the Melbourn Science Park (Cambridge UK), Central Cambridge offices, or Gaithersburg in the US.
Located in stunning offices set in 17 acres of landscaped grounds. The Melbourn Science Park offers an impressive mix of refurbished open plan office space on two floors and a suite of fully furnished conference and meeting rooms. The building benefits from a full height atrium and stunning views overlooking the lake.
Central Cambridge – Located in walking distance from the Train station, you will have access to an onsite gym, restaurant facilities and experience working within a calm and relaxing agile environment, inspired by the University Botanical gardens.
Both sites provide access to a stylish, fully air conditioned fitness centre, an onsite restaurant, Lunch & Learn development activities, all within a bright and spacious environment while utilising the most advanced technology.
Business area 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. A place built on courage, curiosity and collaboration – we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.
We are focused on identifying and treating patients earlier, where there is greater curative potential. With the greatest number of early stage cancer trials in the industry, we are getting closer to finding cures every day.
It’s our unique people-first approach that keeps us grounded and inspired to improve outcomes for all. Listening to our patients to evolve with their needs and tailor their medicines.
What you’ll do The Senior Director, Clinical Programs has a sizeable scope , including accountability for the clinical program strategy and operational design inputs to deliver their assigned program(s) as part of the product development team. Within a program, they maintain accountability for the delivery and reporting of clinical studies to time, quality and cost.
The Clinical Program Director also provides expert input to other non-assigned drug programmes, and process-related improvements and workstreams.
The Clinical Program Director is a key leadership member of the Global Project Team. This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and outside of AstraZeneca.
In collaboration with the Medical Science Director, this role is accountable for the clinical program strategy, including innovative approaches to delivery, e.g., new delivery platforms and technology to ensure patient engagement, recruitment and retention.
- Plans, directs 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
- Responsible for providing strategic and operational input to cross-functional program development plans, data interpretation and accountable for cross-functional leadership roles as delegated from the Global Project Team, e.g., leadership of cross functional product development team activities.
- 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.
- Develops and maintains effective program level risk management/mitigation plans to ensure timely delivery to quality and budget
- Accountable for planning and leading issue escalation and resolution
- Accountable for the acquisition of clinical trial data from internal and external sources
- Input to the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
- Accountable for the quality of study delivery planning information into relevant planning systems
- Accountable for ensuring timely compliance with company-wide governance controls (e.g. Sarbanes-Oxley Act of 2002, Delegations of Authority, study attestations, Letter of Assurance, financial system access, Clinical Trial Disclosure)
- Accountable for coordination of selection of external providers for programme/study specific tasks
- Provision to procurement of clear specifications for program/study specific outsourcing
- Review and operational approval of program/study specific contracts or work orders
- Operational management and oversight of external providers at program/study level
- Engagement with preclinical and translational science as well as statistics and regulatory in order to design and deliver robust clinical development plans.
- Develops, coaches, mentors, motivates and inspires individuals within the organization.
Essential for the role
- Bachelor’s degree in related subject discipline, preferably in medical or biological science.
- Experience in drug development leadership experience with progressive levels of responsibility.
- Comprehensive knowledge of the clinical and pharmaceutical drug development process
- Proven ability 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 complex projects, including resourcing and financial management
- Strong strategic influencing skills; ability to influence broadly within and outside the organisation
- 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 ability in problem solving and issues management that is solution focused
- Extensive and proven experience in driving operational delivery to timelines, cost and quality
- Proven experience of leading delivery through collaboration with internal and external providers
- Excellent knowledge of ICH-GCP principles
- Experience in providing clear requirements for external contracts
- Experience in selection of external providers and development/review of contracts
- Proven oversight of external providers
Desirable for the role
- 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
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.