Senior Operations Lead, Oncology Translational

hace 6 meses

Barcelona, España AstraZeneca A tiempo completo

**Location**: Barcelona

**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 disease. But we’re more than one of the world’s leading pharmaceutical companies.

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most demanding situations because we are committed to doing the right thing. We put patients first and follow the science to bring life-changing medicines to patients that need them.

**About the role and the project**

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. TM are responsible for the biomarker strategy and implementation, which includes analyses of global clinical trial samples. The aim is 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. 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 TM with set-up, oversight and closure of prospective testing for patient selection for entry to global early phase oncology trials. They will also lead delivery of secondary and exploratory biomarker endpoints on selected early and late phase trials.

They are 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, 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 requirements**
- Relevant experience in the biopharmaceutical industry or clinical institution
- Deep understanding of science in relevant areas (e.g. diagnostics, cancer biomarkers, genomics, oncology therapeutics)
- Experience of working with partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
- Ability to interact successfully with multiple stakeholders across functional boundaries, with clear oral and written communication
- Ability to work independently, designing, executing and interpreting tasks
- A confident team player with good interpersonal skills who is assertive but willing to listen and learn from the views of others, able to influence beyond own immediate team
- 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 and track multiple projects simultaneously
- Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, and Quality Systems Regulation

**Desirable requirements**
- Experience of analytical diagnostic a

  • Director, Translational Medicine Lead

    hace 6 meses

    Barcelona, España AstraZeneca A tiempo completo

    Do you feel passionate about the possibilities of great science changing lives of cancer patients? Do you have a background within oncology and/or translational research and have interest in working with antibody-drug and radio conjugates (ADCs and RC’s)? If so, this may be the role for you. We currently have an exciting opportunity for a highly motivated...

  • Senior Director, Translational Medicine, Oncology

    hace 6 meses

    Barcelona, España AstraZeneca A tiempo completo

    We are seeking a Senior Director in Oncology Translational Medicine to join a world class center for discovery and development of innovative cancer medicines. In this role you will be accountable for leading a team for delivery of robust, scientifically-driven biomarkers in drug discovery and development programs for a portfolio of targeted agents across our...

  • Associate Director, Translational Medicine Lead

    hace 6 meses

    Barcelona, España AstraZeneca A tiempo completo

    Do you feel passionate about the possibilities of great science changing lives of cancer patients? Do you have a background within oncology and/or translational research and have interest in working with antibody drug conjugates (ADCs) and an exciting portfolio? If so, this may be the role for you. We currently have an exciting opportunity for a highly...

  • Head of Translational Medicine Oncology Drug

    hace 6 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Head of Translational Medicine Oncology Drug Project Management** **Location: Barcelona, Spain (On-site)** The TM Oncology Drug Project Management group within Translational Medicine Oncology is accountable for providing project and portfolio management to the AZ TM Oncology portfolio to ensure successful delivery of Translational projects from...

  • Director, Translational Medicine, Oncology

    hace 3 semanas

    Barcelona, España AstraZeneca A tiempo completo

    **Position**: Director, Translational Medicine, Oncology **Location**: Barcelona - Spain (3 days working from the office and 2 days working from home) 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...

  • Director, Translational Medicine, Oncology

    hace 2 semanas

    Barcelona, España Astrazeneca A tiempo completo

    .Director, Translational Medicine, Oncology Position: Director, Translational Medicine, Oncology Location: Barcelona - Spain (3 days working from the office and 2 days working from home) 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...

  • Director, Translational Medicine, Oncology

    hace 2 semanas

    Barcelona, España Astrazeneca A tiempo completo

    Director, Translational Medicine, Oncology Position: Director, Translational Medicine, OncologyLocation: Barcelona - Spain (3 days working from the office and 2 days working from home)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...

  • Director, Translational Medicine, Oncology

    hace 2 semanas

    Barcelona, España Astrazeneca A tiempo completo

    Director, Translational Medicine, OncologyPosition: Director, Translational Medicine, OncologyLocation: Barcelona - Spain (3 days working from the office and 2 days working from home)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...

  • Director, Translational Medicine, Oncology

    hace 2 semanas

    Barcelona, España Astrazeneca A tiempo completo

    .Director, Translational Medicine, OncologyPosition: Director, Translational Medicine, OncologyLocation: Barcelona - Spain (3 days working from the office and 2 days working from home)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...

  • Director, Translational Medicine, Oncology

    hace 2 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Position: Director, Translational Medicine, OncologyLocation: Barcelona - Spain (3 days working from the office and 2 days working from home)At Astra Zeneca, 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...

  • Director, Translational Medicine, Oncology

    hace 8 meses

    Barcelona, España AstraZeneca A tiempo completo

    Location: Barcelona (On-site) 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,...

  • Director, Translational Medicine, Oncology

    hace 3 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Director, Translational Medicine, Oncology Position: Director, Translational Medicine, Oncology Location: Barcelona - Spain (3 days working from the office and 2 days working from home) 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...

  • Director, Translational Medicine, Oncology

    hace 2 semanas

    Barcelona, España Astrazeneca A tiempo completo

    Position: Director, Translational Medicine, OncologyLocation: Barcelona - Spain (3 days working from the office and 2 days working from home)At Astra Zeneca, 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...

  • Director, Translational Medicine, Oncology

    hace 6 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Position**: Director, Translational Medicine, Oncology - Breast cancer** **Location**: Cambridge, UK or Boston, US** 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....

  • Director, Translational Medicine, Oncology

    hace 6 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Position**: Director/Associate Director, Translational Medicine, Oncology - DNA damage response** **Location**: Barcelona (primary) with alternative locations as Cambridge UK and Boston US** 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...

  • Associate Director, Translational Data Science

    hace 8 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Associate Director, Translational Data Science, Oncology Data Science, Oncology R&D, AstraZeneca** **Location**:Barcelona, Spain**: **Salary**:Competitive with excellent benefits The Computational Biology group is growing in Barcelona, and we are looking for new team members to join us at different roles (Sr Scientist/ Associate Director). AstraZeneca...

  • Associate Director, Experimental Oncology

    hace 6 meses

    Barcelona, España AstraZeneca A tiempo completo

    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. Within Oncology Translational Medicine (TM), Experimental Oncology supports academic collaborations and external sponsored research that further our understanding of the mechanism of actions...

  • Project Manager, Oncology Translational Medicine

    hace 1 mes

    Barcelona, España AstraZeneca A tiempo completo

    Oncology is a core therapy area and an area of growth at AstraZeneca. 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. TM is responsible for the biomarker strategy and implementation, which includes...

  • Translational Regulatory Affairs Director

    hace 6 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona (on-site)** Are you a strategically focused Regulatory professional who would like to play an integral part in bringing life changing Oncology medicines to patients? If so, please join us! At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover. Within **Oncology Regulatory Science,...

  • Associate Director Of Translational Regulatory Science

    hace 1 mes

    Barcelona, España Astrazeneca A tiempo completo

    .Associate Director of Translational Regulatory Science Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients....