Senior Operations Lead, Oncology Translational

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

**About AstraZeneca**

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we are more than one of the world's leading pharmaceutical companies.

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.

**This Opportunity**

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 Associate Director, TM Operations, will support Translational Medicine with set-up, oversight and closure of prospective and retrospective biomarker testing on clinical samples in oncology trials, delivered by 3rd party labs. Leading the contract biomarker operations to deliver fit-for-purpose lab testing. As a biomarker operations expert they will advise on testing with specific biomarker types, deliver process efficiencies, influence and mentor less experienced team members. They may line manage and/or matrix manage a small team.

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 to implement the selected options, monitoring ongoing activities to ensure quality of data output.

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
- 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.
- ** Train and mentor new operations team members in delivery of biomarker testing within own area of expertise**:

- ** Line manage or matrix manage one or more team members**:

- 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**

**Essential**
- Bachelor's degree required, with at least 3 years of proven 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)
- Extensive experience of delivering clinical biomarker testing
- Experience of working with partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
- Experience

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