Senior Operations Lead, Oncology Translational Medicine

Oncology is a core therapy area and growth platform at AstraZeneca and our vision is to deliver life-changing medicines that improve outcomes for patients most in need.

Oncology Translational Medicine (TM) supports programs in all phases of clinical cancer drug 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. Translational Medicine are responsible for the biomarker strategy and implementation which includes exploratory analyses of global clinical trial samples. The Translational Medicine Biomarker Operations Group’s remit is to deliver this clinical biomarker testing, using 3rd party laboratories.

The Senior Operations Lead  in the Biomarker Operations Group will support Translational Medicine with set-up, oversight and closure of prospective testing for patient selection onto global early phase oncology trials.  They will also lead delivery of secondary and exploratory biomarker endpoints on selected early and late phase trials.

The role holder will work closely with the Translational Medicine Lead and diagnostic vendors to execute the clinical biomarker plan for multiple trials.   They will work closely with the clinical study team and other supporting functions to implement the selected options, monitoring ongoing activities to ensure quality of data output, delivering fit-for-purpose lab testing.

The role holder is accountable for ensuring that all activities are delivered, demonstrating behaviors and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures, including compliant management of budget, safety, health and environment. 

Typical Accountabilities:

• Set up and oversee biomarker testing work packages at third party laboratories, for individual global clinical studies, aligning with the Translational Medicine Lead, and working closely with the clinical team and other supporting functions.

• Work effectively with Procurement and other functions to ensure contracts for biomarker testing commit CROs/labs to deliver timely, fit-for purpose laboratory testing, compliant with clinical sample testing guidelines.

• During trial set-up, provide timely information to the clinical team on sample collection requirements at sites, and on sample logistics. 

• Ensure Regulatory function is supplied with relevant testing data to support Risk Determination assessment and IVDR submissions.

• Lead the creation and maintenance of relevant study documents such as communication, quality management and issue escalation plans, and contribute to Trial Master File.

• Ensure relevant sample meta-data are effectively captured in clinical database and that data transfer requirements are defined for exploratory data.

• Oversee the delivery of biomarker testing, ensuring the frequency and content of data outputs for patient selection and/or exploratory measures are delivered as agreed, monitoring via an agreed QC plan.

• Develop good relations with 3rd party labs, working with TM Alliance Management where relevant, maintaining timely and clear communications, and understanding appropriate routes for matters requiring escalation.

• Build and maintain a knowledge of current and emerging biomarker assay technologies in area of expertise.

• Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and address instances of non-compliance.

Essential:

• Bachelor's degree in relevant subject

• Minimum of 3 years  Relevant experience in the biopharmaceutical industry.  

• Excellent knowledge of scientific literature with deep understanding in relevant areas (e.g. diagnostics, cancer biomarkers, genomics, oncology therapeutics)

• Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, and Quality Systems Regulation)

• Experience of working with partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.

• Ability to  communicate with stakeholders for study updates, reporting progress through oral presentations and written reports

Skills & Capabilities:

• Good interpersonal skills and ability to act as an ambassador for TM/AZ internally and externally

• Ability to interact successfully with multiple stakeholders 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 beyond own immediate team  and apply constructive challenge

• Excellent organisational skills, with the proven ability to deliver high quality work under pressure and against tight timelines

• Attention to detail coupled with ability to manage multiple projects simultaneously

• Ability to identify risks and escalate appropriately

Desirable:

• Demonstrable experience of analytical diagnostic assay validation and/or use in a clinical testing setting.

• Proven experience of delivery and use of data for biomarker projects - including quality control, test data monitoring and troubleshooting

• Experience of outsourcing work packages with commercial partners, developing Statements of Work

• Experience working in early and late phase oncology clinical trials.

• An understanding of drug and companion diagnostic assay co-development

• Masters / PhD or equivalent experience in a relevant subject

Education, Qualifications, Skills and Experience

Locations Waltham, MA or Gaithersburg, MD, or Barcelona

So, what’s next-

Are you already envisioning yourself joining our team? Good! We can’t wait to hear from you!

Competitive remuneration and benefits apply

We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We have a generous paid time off program and a comprehensive benefits package.