Global Medical Affairs Leader, Diagnostics

3 weeks ago

Cambridge, United Kingdom AstraZeneca Full time

A dedicated Oncology unit, this is the place to build a world-class career. AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm with the bold ambition to eliminate cancer as a cause of death. We are proud to work on ground breaking science with one of the broadest and deepest Oncology pipelines in the business.

We are seeking a **Global Medical Affairs Leader (GMAL) for Diagnostics**, to join us at one of our dynamic sites in either the greater DC Metro area in Gaithersburg MD, or Cambridge, UK Reporting to the Head of Diagnostics, OBU Global Medical, the GMAL will play a key leadership role, working to define and deliver medical strategies across a tumor area and will work collaboratively with colleagues on cross Tumor asset strategies. The post holder will have specific ownership of key strategic elements of the medical plans, for complex, large/multiple indications or have full responsibility for the medical plan single indications.

**What You'll Do**:
Serving as the strategic leader, representing the Medical vision in key internal forums driving agenda items and actioning accordingly, the key tasks of the Diagnostic GMAL include:

- Ensure the timely, quality input into global medical and lifecycle plans, to support optimal in-market companion diagnostics / testing solutions that enable optimal treatment choices and support patient access to the right drugs.
- Accountable for developing strategic and long-term partnerships with relevant external Oncology stakeholders and decision makers.
- Accountable, based on an understanding of the testing environment and the pathology of the tumor/micro-environment, for leading on defining strategic diagnostic interventions and tailored testing solutions.
- Be responsible for the leadership of all Medical Affairs activities related to diagnostics, in collaboration with the other Tumor/Asset medical leaders.
- Contribute to the broader strategic planning to build Astra Zeneca's medical leadership in the medical diagnostics arena.
- Deliver medical diagnostics insights into the development and execution of the overall Tumor/Asset strategy

**Minimum Qualifications**:

- Minimum of 4 years’ experience in pharma/life sciences and/or medical experience (e.g. significant clinical/academic/medical affairs agency roles/organizations)
- Minimum of Master’s degree in a scientific discipline or equivalent medical/scientific qualifications and/or significant industry and/or therapeutic experience.
- Diagnostics/Assay development/deployment knowledge and experience
- Good communication and presentation skills in English
- Experience of multistakeholder management
- Experience of leading on medical plans and strategic medical initiatives
- Ability to influence others without authority
- Strong project management skills and the ability to work effectively with cross-functional teams
- Good understanding of drug development and commercialization processes including understanding of outcomes research /payer access issues
- Proven ability to generate, analyze and interpret clinical trial and published data

**Preferred Qualifications**
- Advanced Scientific degree preferred (PhD, PharmD)
- Oncology experience
- Country launch experience
- Documented track record of successfully developing and executing Medical Plans both in terms of evidence generation, scientific communications, and external expert engagements

  • Global Medical Affairs Leader, Immunology

    7 days ago

    Cambridge, United Kingdom AstraZeneca Full time

    Introduction to role: Join our industry-leading BioPharmaceuticals team as a Global Medical Affairs Leader (GMAL) in Immunology. This strategic role offers the unique opportunity to combine your medical expertise with insights from markets, healthcare professionals, patients, and health systems to develop and execute world-class medical strategies for...

  • Global Medical Affairs Leader, Respiratory Inhaled

    6 days ago

    Cambridge, United Kingdom AstraZeneca Full time

    At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible. AstraZeneca is a science-led, global biopharmaceutical company, with a focused portfolio in core therapies. We are committed to improving the health and lives of people across the globe, through our...

  • Tumour Portfolio Leader, Obu Medical Affairs

    1 month ago

    Cambridge, United Kingdom AstraZeneca Full time

    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...

  • Global Medical Head, Immunology

    7 days ago

    Cambridge, United Kingdom AstraZeneca Full time

    Salary: Competitive & Excellent benefits package Location: Cambridge Closing date for all applications: 3rd May 2024 BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (AZ) therapies. We support our internal stakeholders with...

  • Global Regulatory Affairs, Associate Director

    1 month ago

    Cambridge, United Kingdom Gilead Sciences International, Ltd. Full time

    Description We are looking for a driven individual who is passionate about bringing transformational medicines to those in Europe and international countries with continued unmet medical need. This is an exciting opportunity for a Regulatory Affairs Associate Director to join the Gilead Global Regulatory Affairs Oncology team to support drug...

  • Global Regulatory Affairs, Associate Director

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Global Regulatory Affairs, Associate Director (Oncology) page is loaded Global Regulatory Affairs, Associate Director (Oncology) Apply locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Posted 6 Days Ago job requisition id R0040717 For Current Gilead Employees and Contractors: Please log onto your Internal Career...

  • Global Regulatory Affairs, Associate Director

    5 days ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Global Regulatory Affairs, Associate Director (Oncology) page is loaded Global Regulatory Affairs, Associate Director (Oncology) Apply locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Posted 6 Days Ago job requisition id R0040717 For Current Gilead Employees and Contractors: Please log onto your Internal Career...

  • Technical Project Leader

    7 days ago

    Cambridge, United Kingdom TTP Full time

    The Diagnostics team at TTP is committed to the development of diagnostic solutions that make high performance testing as broadly accessible as possible. We partner with start-ups and world-leading diagnostics companies to bring new products to market, working in close-knit teams of biologists, chemists, physicists, and engineers. We're now seeking an...

  • Senior Regulatory Affairs Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Senior Regulatory Affairs Manager CMC A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto injector)...

  • Senior Regulatory Affairs Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Senior Regulatory Affairs Manager CMC A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto injector)...

  • Quality and Regulatory Affairs Specialist

    7 days ago

    Cambridge, United Kingdom Biochrom Full time

    Biochrom is part of Harvard Bioscience (HBIO), a global business providing life science, laboratory apparatus worldwide. Reporting to Biochrom QRA Manager, the **Quality and Regulatory Affairs Specialist** (QRA Specialist) supports our _in-vitro_ diagnostic product registrations, timely undertaking of post market surveillance as well as monitoring...

  • Senior Manager, Regulatory Affairs

    4 weeks ago

    Cambridge, United Kingdom Relay Therapeutics Full time

    The Opportunity: We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to ​help define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the regulatory representative on relevant project teams...

  • Regulatory Affairs Specialist

    1 month ago

    Cambridge, United Kingdom Vector Recruitment Limited Full time

    Regulatory Affairs Specialist £45k-£55k (dep on exp) Cambridge We have a brand-new vacancy for a Regulatory Affairs Specialist to join a fascinating Cambridge based R&D technology company. This business is very well established and is undergoing rapid growth due to the impact that their market disruptive technology is having on the medical...

  • Associate Regulatory Affairs Director

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Global Regulatory Affairs, Associate Director (Oncology) page is loaded Global Regulatory Affairs, Associate Director (Oncology) Apply locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Posted 6 Days Ago job requisition id R0040717 For Current Gilead Employees and Contractors: For more than 35 years, we’ve...

  • Associate Regulatory Affairs Director

    5 days ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Global Regulatory Affairs, Associate Director (Oncology) page is loaded Global Regulatory Affairs, Associate Director (Oncology) Apply locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Posted 6 Days Ago job requisition id R0040717 For Current Gilead Employees and Contractors: For more than 35 years, we’ve...

  • Verification Engineer

    3 days ago

    Cambridge, United Kingdom LEX Diagnostics Full time

    LEX is currently seeking a Verification and Validation Engineer who will actively engage in hands-on testing of the LEX diagnostic system. You will be working closely with the head of Quality and Engineering team and will be responsible for defining, designing, and executing verification and validation activities for the LEX 5-minute PCR diagnostic...

  • Verification Engineer

    3 days ago

    Cambridge, United Kingdom LEX Diagnostics Full time

    LEX is currently seeking a Verification and Validation Engineer who will actively engage in hands-on testing of the LEX diagnostic system. You will be working closely with the head of Quality and Engineering team and will be responsible for defining, designing, and executing verification and validation activities for the LEX 5-minute PCR diagnostic...

  • Verification Engineer

    3 days ago

    Cambridge, United Kingdom LEX Diagnostics Full time

    LEX is currently seeking a Verification and Validation Engineer who will actively engage in hands-on testing of the LEX diagnostic system. You will be working closely with the head of Quality and Engineering team and will be responsible for defining, designing, and executing verification and validation activities for the LEX 5-minute PCR diagnostic...

  • Verification Engineer

    35 minutes ago

    Cambridge, United Kingdom LEX Diagnostics Full time

    LEX is currently seeking a Verification and Validation Engineer who will actively engage in hands-on testing of the LEX diagnostic system. You will be working closely with the head of Quality and Engineering team and will be responsible for defining, designing, and executing verification and validation activities for the LEX 5-minute PCR diagnostic...

  • Verification Engineer

    3 days ago

    Cambridge, United Kingdom LEX Diagnostics Full time

    LEX is currently seeking a Verification and Validation Engineer who will actively engage in hands-on testing of the LEX diagnostic system. You will be working closely with the head of Quality and Engineering team and will be responsible for defining, designing, and executing verification and validation activities for the LEX 5-minute PCR diagnostic...