Global Development Scientist Director, Lung Late
hace 3 semanas
**Lung, Research & Development, Late Development Oncology**
**Our ambition is to eliminate cancer as a cause of death**. It’s our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Focusing on cutting-edge science with the latest technology to achieve breakthroughs. AZ is a place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes.
Within **Late Development Oncology,** we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what’s next. Supportive team players, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges.
**What you’ll do**
The **Global Development Scientist Director** is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working harmoniously and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The Medical Scientist and counterpart Study Physician work collaboratively in the clinical aspects underpinning a clinical program. This includes shared responsibility with Clinical Operations team members in the planning and execution, including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies. As such, you will provide clinical/scientific 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 NDA/BLA).
The **Global Development Scientist Director** may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area 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 (GCP) and regulatory requirements. Depending upon experience level, the role will mentor the development of less experienced members of the clinical team, and may involve direct line management.
Other responsibilities include but are not limited to:
- Work cross functionally within CPT to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents
- Significant contributor to the development of program strategy for assigned compounds/programs and work with GPT/CPT members to develop a compelling business case for governance approval.
- Provide expert clinical input to shape 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
- Supports or leads interactions with global medical affairs, marketing companies, commercial, in collaboration with GCH/GCPL to ensure cross functional input into protocols.
- Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests. Contribute to development and delivery of face to face or virtual investigator and monitor training.
- Support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warranted.
**Essential for the role**
- Bachelor’s degree with focus on life sciences or equivalent
- ** Significant Industry or academic experience in drug development required with oncology therapeutic experience**
- Possesses sound foundational knowledge of FDA and other major country regulations.
-
Global Development Scientist Director, Late
hace 1 mes
Barcelona, España AstraZeneca A tiempo completo**Our ambition is to eliminate cancer as a cause of death**. It’s our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Focusing on cutting-edge science with the latest technology to achieve breakthroughs. AZ is a place built on courage, curiosity...
-
Global Development Scientist Director
hace 1 mes
Barcelona, Barcelona, España AstraZeneca A tiempo completoThe Global Development Scientist Director will provide scientific and clinical input to all aspects of late stage product development for respiratory assets. This includes but is not limited to the design, delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of products in...
-
Barcelona, España AstraZeneca A tiempo completo**Diverse Minds. Go further with bold new opportunities. Collaborate with diverse minds.**: Collaborate in an inclusive environment, a place full of bold new opportunities. And in returnwe’re looking for people who are open and respectful, ambitious and driven. **What you'll do**: The Clinical Global Development Scientist Director will provide scientific...
-
Global Development Scientist Director
hace 1 mes
Barcelona, España AstraZeneca A tiempo completoThe Global Development Scientist Director will provide scientific and clinical input to all aspects of late stage product development for respiratory assets. This includes but is not limited to the design, delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of products in...
-
Global Development Scientist Director, Late Oncology
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completo**Loction: Barcelona (On-site)** We are looking to hire a Global Development Scientist Director Late Oncology. Do you have expertise in, and passion for clinical drug development? Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? Join the team at the heart of AstraZeneca dedicated to...
-
Global Development Medical Director, Late Oncology
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completo**Global Development Medical Director** **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...
-
Global Development Scientist Director
hace 1 mes
Barcelona, España AstraZeneca A tiempo completo**Our ambition is to eliminate cancer as a cause of death**. It’s our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Focusing on cutting-edge science with the latest technology to achieve breakthroughs. AZ is a place built on courage, curiosity...
-
Senior Global Development Scientist Director
hace 1 mes
Barcelona, España AstraZeneca A tiempo completo**Job Title: Senior Global Development Scientist Director**: **Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA**: As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes but...
-
Barcelona, España AstraZeneca A tiempo completo**Senior Global Development Medical Director** **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...
-
Senior Global Development Medical Director, Late
hace 1 semana
Barcelona, España AstraZeneca A tiempo completo**Job Description**: **Senior Global Development Medical Director** **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...
-
Barcelona, Barcelona, España AstraZeneca A tiempo completoLocation: Barcelona (on-site)We are looking for a Global Development Medical Director, Late OncologyDo you have expertise in Oncology clinical drug development and passion for developing late phase clinical program strategies?Would you like to apply your expertise to impact the way cancer is treated, and make a meaningful difference to patients, in a company...
-
Barcelona, España AstraZeneca A tiempo completoLocation: Barcelona (on-site)We are looking for a Global Development Medical Director, Late OncologyDo you have expertise in Oncology clinical drug development and passion for developing late phase clinical program strategies?Would you like to apply your expertise to impact the way cancer is treated, and make a meaningful difference to patients, in a company...
-
Director Clinical Scientist
hace 6 días
Barcelona, España AstraZeneca A tiempo completo**Director Clinical Scientist - Hematology Early Oncology R&D*** **Locations flexible: US: San Francisco, CA Gaithersburg, MD, Waltham, MA** **Barcelona, Spain or Mississauga, CN** 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...
-
Global Clinical Development Medical Director
hace 1 mes
Barcelona, España AstraZeneca A tiempo completo**Opportunity**: Global Clinical Development Medical Director **Business Unit**:Vaccines and Immune Therapies (COVID-19 / Respiratory Syncytial Virus (RSV) / Influenza) **Salary**: Competitive, with excellent benefits **Make a more meaningful impact to patients’ lives around the globe** With our ground-breaking Vaccines and Immune Therapy pipeline, the...
-
Barcelona, España AstraZeneca A tiempo completoThe Director, Business Planning and Operations (BPO), supports the Late-stage Development Respiratory and Immunology (Late R&I) organisation with critical aspects of its business operations and performance through effective project/change management and continuous improvement. This involves the management of Late R&I strategic initiatives and chief of staff...
-
Global Development Imagining Scientist
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completoThe Clinical Imaging Scientist (“CIS”) will provide strategic and technical expertise on the conception and implementation of imaging strategies in all phases of clinical development (Phase I-III) within the Oncology portfolio. The role is focused on implementation of standard methodology imaging and tumor assessment for key primary, secondary and...
-
Global Development Imaging Scientist
hace 4 semanas
Barcelona, España AstraZeneca A tiempo completoThe Clinical Imaging Scientist (“CIS”) will provide strategic and technical expertise on the conception and implementation of imaging strategies in all phases of clinical development (Phase I-III) within the Oncology portfolio. The role is focused on implementation of standard methodology imaging and tumor assessment for key primary, secondary and...
-
Director, Clinical Development
hace 2 días
Barcelona, España Arto A tiempo completoEmail Senior Recruitment Consultant at ARTO RecruitmentARTO is currently partnered with a global Immunology pharmaceutical company who are specialised in providing medicines for diseases within the Rheumatology/Dermatology space.They are currently searching for a Director of Clinical Development to join the team and work on a number of clinical studies...
-
Analytical Development Scientist
hace 5 días
Barcelona, Barcelona, España Claire Joster A tiempo completoSomos la firma global de talento: Selección, headhunting, formación y consultoría de Eurofirms Group.En Claire Joster creemos en el talento único de cada persona y sabemos que la diversidad aporta valor a los equipos, impulsando organizaciones más innovadoras, creativas y eficientes. Por eso, como parte de Eurofirms Group, y de acuerdo con nuestra...
-
Analytical Development Scientist
hace 5 días
Barcelona, España Claire Joster A tiempo completoSomos la firma global de talento: Selección, headhunting, formación y consultoría de Eurofirms Group.En Claire Joster creemos en el talento único de cada persona y sabemos que la diversidad aporta valor a los equipos, impulsando organizaciones más innovadoras, creativas y eficientes. Por eso, como parte de Eurofirms Group, y de acuerdo con nuestra...
