Global Development Medical Director Hematology

hace 7 meses

Barcelona, España AstraZeneca A tiempo completo

**About AstraZeneca**

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies.

AstraZeneca has a multifaceted environment that cultivates collaboration and innovation. We attract top minds, and we nurture and build talent.

**Hematology Research and Development, Early and Late Development Hematology**

Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy and Epigenetics) to help address unmet clinical needs in a host of hematological cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death. This unit has responsibility for the value chain from discovery through to late-stage development, enabling rapid acceleration of promising early-stage assets and life-cycle management programs

**Role and Responsibilities**:
**The **Global Development Medical Director** is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The Global Development Medical Director and counterpart Global Development Scientist work collaboratively in the clinical aspects underpinning a product. Accountabilities include clinical support for the development and implementation of **early and/or late** phase AstraZeneca sponsored clinical program strategies, including providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to (s)NDA/(s)BLA).**:
**The Global Development Medical Director plays a critical role in the medical monitoring of a clinical study ensuring safety to patients. They share responsibility with Clinical Operations team members in the planning, execution and closure of a clinical study. The Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset, cross-indication working groups depending on the level of experience.**:
**This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.**:
**Main duties**:

- ** Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as AZ SOPs regarding safety**
- Work cross-functionally and lead all aspects of the design and implementation of clinical hemato-oncology projects, as a leader of our Clinical Product Team (CPT) and member of the Clinical Sub-Team (CST). Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
- Significant contributor to the development of program strategy for assigned compound(s)/programs and work with GPT/CPT members to develop a compelling business case for governance approval
- Provide expert clinical input to influence the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets the strategic program objectives.
- Participate or lead as needed the review and assessment of new opportunities and ESRs.
- Accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.
- Provides expert input into/lead the development of the protocol and related documents and the development and delivery of the clinical study report
- Full responsibility for the planning, implementation and daily operation of assigned drug development projects in hemato-oncology.
- Supports or leads interactions with glob

  • Global Development Medical Director Hematology

    hace 7 meses

    Barcelona, España AstraZeneca A tiempo completo

    **_This opportunity is available at our R&D HUB in Barcelona._** **About AstraZeneca** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading...

  • Global Development Medical Director Hematology

    hace 7 meses

    Barcelona, España AstraZeneca A tiempo completo

    **_This opportunity is available at our R&D HUB in Barcelona._** **About AstraZeneca** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading...

  • Associate Director, Global Medical Information And Medical Review

    hace 3 meses

    Barcelona, España Medical Assistant A tiempo completo

    This is what you will do:The Associate Director of Global Medical Information and Medical Review is responsible for managing Global Medical Information service functions within a given therapeutic area (TA), including but not limited to the medical review of promotional and scientific materials, and planning and implementation of medical information...

  • Global Development Medical Director

    hace 6 días

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    .As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader (GCPL) and Global Clinical Head (GCH) with the design and interpretation process, establishing clear design objectives for clinical programs and studies. Provide medical input into the content of core labelling texts and medical...

  • Global Development Medical Director

    hace 6 días

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    .As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader (GCPL) and Global Clinical Head (GCH) with the design and interpretation process, establishing clear design objectives for clinical programs and studies. Provide medical input into the content of core labelling texts and medical...

  • Global Development Medical Director

    hace 2 días

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    .As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader (GCPL) and Global Clinical Head (GCH) with the design and interpretation process, establishing clear design objectives for clinical programs and studies. Provide medical input into the content of core labelling texts and medical...

  • Global Development Medical Director

    hace 7 días

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader (GCPL) and Global Clinical Head (GCH) with the design and interpretation process, establishing clear design objectives for clinical programs and studies. Provide medical input into the content of core labelling texts and medical...

  • Medical Director

    hace 7 meses

    Barcelona, España AstraZeneca A tiempo completo

    **_This opportunity is available at our Gaithersburg, MD, Waltham, MA (USA); Mississauga (CAN); or Barcelona (ESP) location._** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more...

  • Medical Affairs Manager

    hace 1 mes

    Barcelona, Barcelona, España Grifols Sa A tiempo completo

    Medical Affairs Manager - Hematology SpecialistGrifols Sa is seeking a Medical Affairs Manager - Hematology Specialist to join our international team. As a key member of our Medical Affairs department, you will be responsible for building partnerships with external healthcare professionals and internal stakeholders to communicate evidence-based critical...

  • Global Development Medical Director

    hace 6 días

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader (GCPL) and Global Clinical Head (GCH) with the design and interpretation process, establishing clear design objectives for clinical programs and studies. Provide medical input into the content of core labelling texts and medical...

  • Global Development Medical Director

    hace 6 días

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader (GCPL) and Global Clinical Head (GCH) with the design and interpretation process, establishing clear design objectives for clinical programs and studies. Provide medical input into the content of core labelling texts and medical...

  • Senior Medical Director

    hace 7 meses

    Barcelona, España AstraZeneca A tiempo completo

    **_This opportunity is available at our Gaithersburg, MD, Waltham, MA (USA); Mississauga (CAN); or Barcelona (ESP) location._** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more...

  • Sr. Global Development Medical Director, Late |

    hace 2 meses

    Barcelona, España Empresa Reconocida A tiempo completo

    .Global Development Medical Director (Sr. Director/Director - Lung)About AstraZeneca: AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. We are more than one of the world's leading...

  • Global Development Medical Director

    hace 6 días

    Barcelona, España AstraZeneca GmbH A tiempo completo

    As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader (GCPL) and Global Clinical Head (GCH) with the design and interpretation process, establishing clear design objectives for clinical programs and studies. Provide medical input into the content of core labelling texts and medical...

  • Associate Director, Global Medical Information And Medical Review

    hace 3 meses

    Barcelona, España Medical Assistant A tiempo completo

    .This is what you will do:The Associate Director of Global Medical Information and Medical Review is responsible for managing Global Medical Information service functions within a given therapeutic area (TA), including but not limited to the medical review of promotional and scientific materials, and planning and implementation of medical information...

  • Vp, Medical

    hace 5 meses

    Barcelona, España Iqvia A tiempo completo

    Job Overview The Vice President Medical Strategy and Head of the Hematology / Oncology COE provides strategic medical and scientific leadership, subject matter experience and expertise to IQVIA and to IQVIA's clients in Hematology and Oncology. The overarching remit is to grow IQVIA's market share in hematology and oncology and will develop strategies toward...

  • Director, Global Dev Scientist

    hace 6 meses

    Barcelona, España AstraZeneca A tiempo completo

    **_This opportunity is available at our Gaithersburg, MD, Waltham, MA (USA); Mississauga (CAN); or Barcelona (ESP) location._** Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology,...

  • Global Development Medical Director

    hace 5 meses

    Barcelona, España AstraZeneca A tiempo completo

    As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader (GCPL) and Global Clinical Head (GCH) with the design, implementation, conduct and interpretation of Phase 2b to Phase IV studies to support immunological product development and regulatory approvals in line with the target...

  • Medical Director- Oncology/Hematology

    hace 2 meses

    Barcelona, España Iqvia A tiempo completo

    Job Overview The medical department consists of a Chief Medical Officer, Medical Directors, medical writers, and safety associates.The Medical Director provides medical and scientific support to clinical research programs, study teams, and investigators.The Medical Director also provides review, advice, and leadership for potentially or awarded clinical...

  • Medical Affairs Manager

    hace 1 mes

    Barcelona, Barcelona, España Grifols Sa A tiempo completo

    Medical Affairs Manager - Hematology ExpertGrifols Sa is seeking a Medical Affairs Manager - Hematology Expert to join our team. As a Medical Affairs Manager - Hematology Expert, you will be responsible for building partnerships with external healthcare professionals and internal stakeholders to communicate evidence-based critical scientific, technical, and...