Associate Director Scientist, Early Oncology Global Development
hace 2 semanas
Location: Barcelona, Spain (3 days working from the office and 2 days working from home)
The AD Scientist is an important member of the Project Team, working under the supervision of a clinical lead/study physician or senior clinical scientist, supporting activities related to the medical scientific aspects of the compound and its development. The accountabilities are broad, however, the core accountabilities are the medical & scientific support for the development and implementation of early phase Astra Zeneca sponsored clinical program strategy, externally sponsored collaborative research program strategy and studies, including clinical science support for initiating clinical trial(s), supporting clinical data review, interpretation of the study results and supporting final recommendations to senior management.
As a key member of the Global Project Team, 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 Astra Zeneca.
Typical Accountabilities
The following tasks would be performed under the guidance of the clinical lead, physician or a senior member of the Clinical Science team, with the expectation that over time the AD Scientist would function more independently.
Program Level:
- Assists with the clinical input to the clinical development plan at all stages of the program.
- Supports the science-to-man sub team (TSST) to integrate the biology, translational and clinical science into the program strategy
- Supports in developing recommendation(s) on further development strategies to internal committees
- Supports the preparation of clinical and other data for governance and other presentations
- Supports the preparation of program level documents such as the investigators brochure and DUSR.
- Follows important developments and trends in the medical & scientific literature and disseminates updates to the project team and beyond ensuring all involved parties are aware of key developments and the impact on the strategy, with physician or senior clinical scientist support.
- Supports the collaboration with the Lead Bio-scientist and Translational scientist to provide clinical input to the development and review of data for input to the development of pre-CDID compounds
- Supports the development and review of content and quality of publications and inputs to development of the publication strategy
Study level (when assigned as clinical science resource for study):
- The AD Scientist will support the study lead or in some instances serve as the clinical lead for the study
- Supports aspects of the Clinical Development Plan (CDP) and Clinical Study Protocols in keeping with the approved CDP and ensuring linkage of trial data to target product profile
- Supports with clinical data review and interpretation at the study and program level with input from the study or program physician
- Supports the compilation and interpretation of the data for and from the dose escalation committee/safety review committee, in collaboration with the program physician
- Supports the preparation of clinical and other data for governance and other presentations
- Supports medical and scientific input to specific studies as required by the program clinical lead/study physician
- Supports updates for the protocols, amendments, and other relevant strategic documents. Supports the review of the Clinical Study Report
External:
- Supports development of investigator/site relationships to support site selection and study start up activities
- Co-leads/supports the development and implementation of the externally sponsored collaborative research (ESCR) strategy for a program. The clinical scientist is the link between the project team and all external clinical research for the program.
- Co-leads/Supports investigator and site relationships for clinical proposal reviews, protocol review and approval, scientific oversight and discussions for academic basket/umbrella study and ESCR studies
- Identifies and manages risks within the ESCR portfolio, raises quality issues through the appropriate channels, maintains communications with key Astra Zeneca stakeholders as required.
- Supports the physician/senior clinical scientist in representing the project internally and externally with key external experts. Supports development of alliances as appropriate.
Other:
- Based on areas of expertise, supports development of individuals within the team, including secondees and graduates via a buddy system
- Operates in compliance with GCP and relevant regulatory guidelines.
Education, Qualifications, Skills and Experience
Essential
- Relevant Clinical or Biomedical M.Sc. or relevant Pharmacy, Nursing, MSc/MRes degree
- Clinical drug development or medical research experience demonstrated (> 2 years) within a pharmaceutical/biotech or academic environment
- Basic knowledge of clinical oncology practice and the science of cancer, with the ability to rapidly acquire knowledge
- Experience supporting delivery and influencing at senior leadership levels both internally and externally
- Experience in working and leading in matrix teams
- Strong collaborative communications skills including the ability to engage with a diverse internal and external client base and manage through conflict
- Proven ability in problem solving and issues management that is solution focused
- Experience in collaborating externally, influencing delivery and scientific engagement.
Desirable
- Relevant Clinical or Biomedical Ph.D
- A good understanding of the clinical and pharmaceutical drug development process
-
Associate Director of Translational Regulatory Science
hace 2 semanas
España AstraZeneca A tiempo completoAssociate Director of Translational Regulatory ScienceWithin 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. We...
-
Statistical Science Director
hace 2 semanas
España AstraZeneca A tiempo completoStatistical Science Director - Early Oncology Location: Barcelona Competitive salary and benefits Play a critical role in making our pipeline accessible to patients. Do you have expertise in, and passion for, Biostatistics? Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the...
-
Associate Director Insights
hace 2 semanas
España Regeneron Pharmaceuticals, Inc A tiempo completoThe Associate Director Insights & Analytics (Oncology International) will provide strategic expertise to help optimize business performance and enable informed decision making. The role will report directly to the Director, Insights & Analytics (Oncology International). In addition, this role will oversee International Oncology performance analytics, as well...
-
Associate Director, Safety Scientist, Global Patient Safety
hace 2 semanas
España AstraZeneca GmbH A tiempo completoThis is what you will do:The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across...
-
Associate Director, Safety Scientist, Global Patient Safety
hace 2 semanas
España AstraZeneca GmbH A tiempo completoThis is what you will do:The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across...
-
Statistical Science Director
hace 2 semanas
España AstraZeneca GmbH A tiempo completoStatistical Science Director - Early OncologyLocation: BarcelonaCompetitive salary and benefitsPlay a critical role in making our pipeline accessible to patients.Do you have expertise in, and passion for, Biostatistics? Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the...
-
Associate Director Insights
hace 2 semanas
España Regeneron A tiempo completoThe Associate Director Insights & Analytics (Oncology International) will provide strategic expertise to help optimize business performance and enable informed decision making. The role will report directly to the Director, Insights & Analytics (Oncology International). In addition, this role will oversee International Oncology performance analytics, as well...
-
Senior associate global access strategy
hace 1 semana
España NTT DATA A tiempo completoFilter Showing 484 associate global access strategy jobs in Spain Remote (81) Home-Office (0) Full-time (481) Part-time (3) Minijob (0) Apprenticeship (0) Internship (5) Freelancer (0) Temporary (1) Gig job (0) Career changer (0) (V698) | Associate Manager, Scale Customer Success Ivanti·Spain Who We Are:In...
-
Medical Director
hace 2 semanas
España Precision Medicine Group, LLC. A tiempo completoMedical Director - Clinical Trial ServicesRemote HungaryJob Type: Regular Full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4774Precision for Medicine is hiring a Medical Director to join our team, candidates can work remotely in any of the following locations: UK, Spain, Poland, Hungary, Romania, Serbia or...
-
Junior Technology Scientist Associate
hace 2 días
España Abbott Laboratories A tiempo completoAbout Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Working at Abbott At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life. You...
-
Junior Technology Scientist Associate
hace 2 días
España Abbott Laboratories A tiempo completoAbout AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Working at Abbott At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life. You...
-
Junior Technology Scientist Associate
hace 5 días
España Abbott Laboratories A tiempo completoAbout Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life....
-
Junior Technology Scientist Associate
hace 3 días
España Abbott A tiempo completoJOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live...
-
Lead Statistical SAS Programmer, Oncology, Single Sponsor
hace 2 semanas
España MAI Fortrea Development Limited A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Associate Director Strategy Global Marketing
hace 2 semanas
España Almirall A tiempo completoAs an Associate Director Global Marketing in AD, you will play a critical role in shaping the future of our dynamic Global Marketing team, based in Barcelona. Reporting directly to the Global Marketing Director for Atopic Dermatitis (AD), you will be responsible for leading the Global Long Term Strategy for the successful launch of a new, promising biologic...
-
España Global ERS A tiempo completoThis is what you will do: The Associate Director (AD), Scientific Communications, metabolic leads the successful development and implementation of global communications strategies, and publications plans external medical education in the assigned therapeutic areas in alignment with Alexion brand and corporate strategies. The AD will chair the respective TA...
-
[Oncology]Local Study Associate Director
hace 2 semanas
España AstraZeneca GmbH A tiempo completoAstraZeneca is expanding our therapeutic area into cell therapy, and therefore searching for potential leaders who can manage cell therapy clinical studies.LSAD is to lead Local Study Team(s) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Procedural Documents,...
-
Global Study Associate Director Late Oncology
hace 17 horas
España AstraZeneca GmbH A tiempo completoLocation: Barcelona, Spain (On-site). 3 days working from the office and 2 days working from home.The Global Study Associate Director (GSAD) is responsible for the delivery of clinical studies, including quality, timelines, budgets, resources, investigational sites, vendors, and key project deliverables in compliance with SOPs, Regulatory requirements and...
-
Global Program Manager
hace 2 semanas
España Scopely A tiempo completoWe are hiring a Global Program Manager, Early Careers (Fixed Term) to expand our Early Career recruiting strategy & program globally for the next 12 months.At Scopely, we care deeply about what we do and want to inspire play, every day - whether in our work environments alongside our talented colleagues, or through our deep connections with our communities...
-
Business Development Associate
hace 3 días
España Aristocrat A tiempo completoBusiness Development Associate - French, Barcelona Barcelona - ESP The Business Development Associate is an important member of the sales team responsible for assisting the Sales Managers and/or the Sales Director within the Sales Territory of Southern Europe to meet quarterly and annual sales targets. This role includes internal and external...
