Oncology Translational Medicine Operations Lead
At AstraZeneca, we work together across global boundaries to make an impact and find
answers to challenges. We do this with the utmost integrity even in the most difficult
situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe!!
We are seeking an Operations Lead in Oncology Translational Medicine to join a world class centre for discovery and development of innovative cancer medicines.
Are you ready to make that step and join us to see how you can impact the lives of people
living with cancer?
Translational Medicine supports programs in all phases of development and focuses on
making measurements on human samples to understand why, and identify which, patients benefit from particular treatments, what doses and schedules of treatments to use and the mechanisms underlying the development of resistance to treatment.
In early oncology studies, Translational medicine are responsible for the biomarker strategy and implementation which includes all exploratory analyses of clinical trial samples and
prospective testing for trial recruitment where required.
You will work closely with the Translational Medicine Leader and diagnostic vendors to
develop options for biomarker testing, collaborating with the clinical study team to implement the selected options. Monitoring ongoing activities to ensure quality of data output and being accountable for ensuring that all activities are delivered, demonstrating behaviours and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures, including compliant management of budget, safety, health and environment.
Main Responsibilities and Duties:
- Lead the delivery of the biomarker plan for individual clinical studies, ensuring that is based on translational strategy led by the translational, agreed by product teams working closely with the team and other supporting functions.
- Engage and leverage Translational Medicine expertise where novel technologies or vendors are being considered
- Work effectively with procurement to contract the biomarker operations to deliver fit-for purpose laboratory testing from sample receipt to delivery of results, aligned with clinical sample testing guidelines where necessary.
- Ensure biomarker plan commits CROs/laboratories to deliver timely, fit for purpose testing with sufficient clarity on input for the team to develop site requirements and contracts for sample logistics.
- Ensure regulatory function supplied with relevant testing data to support risk determination assessment
- Lead the creation and maintenance of study documents such as communication, quality management and issue plans.
- Ensure the frequency and content of data outputs for patient selection and/or exploratory measures are delivered as agreed with vendor and clinical team
- Ensure relevant sample meta-data effectively captured in clinical database
- Review and approve sample instructions for clinical sites
- Monitor biomarker data quality and timeliness via agreed QC plan, provide scientific troubleshooting when necessary.
- Build and maintain a knowledge of current and emerging biomarker assay technologies in area of expertise.
- Be accountable for the time, cost and quality of agreed deliverables.
- Provide dedicated Translational Medicine Alliance Management support for assigned vendor(s) as needed, working with Scientific Program Manager for matters requiring escalation.
- Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and address instances of non-compliance.
Education, Qualifications, Skills and Experience
- Bachelor's degree required, with at least 5 years of relevant experience in the biopharmaceutical industry
- Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting.
- Excellent knowledge of scientific literature with deep understanding in diagnostic related area demonstrated through publications in peer reviewed journals.
- Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, Quality Systems Regulation)
- Proven experience of delivery and use of data for biomarker projects - including quality control, test data monitoring and troubleshooting
- Experience of working with testing partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
- Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports
- Ability to identify risks and escalate appropriately
Skills & Capabilities
- Good interpersonal skills and ability to act as an ambassador for TM/AZ internally and externally
- Ability to interact successfully with multiple customers across functional boundaries
- Ability to work independently, designing, executing and interpreting tasks
- Can identify and address critical issues in the context of strategic direction
- A confident team player who is assertive, but willing to listen and learn from the views of others
- Ability to influence within own subject discipline and apply constructive challenge
- Excellent organisational skills, with the proven ability to deliver high quality work under pressure and against tight timelines
- Willingness to travel both nationally and internationally if required
- Masters / PhD or equivalent experience in a relevant subject
- An understanding of drug and companion diagnostic assay co-development and experience working in early and late phase projects.
- Understanding of related areas e.g. segmentation tool discovery, drug-diagnostic co-development.
Next steps - If this describes you, don't hesitate in applying today!!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.