Global Clinical Program Lead Oncology R&d - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 2 días

Publicado por:

Isabel García

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Descripción

At AstraZeneca when we see an opportunity for change, we seize it and commit real resources to make it happen, because an opportunity no matter how small can be the start of something big.

Delivering life-changing medicine is about being entrepreneurial - finding those moments and recognizing their potential. Big success can come from seeing potential in something small. We empower our people to seek these out, and we support them to pursue the opportunities they find.

We are seeking a strategic
Global Clinical Program Lead with deep understanding of the Oncology therapeutic area, with specific expertise in oncology, to join our
Late Oncology team at
AstraZeneca.

As Global Clinical Program Lead (GCPL), you will be part of a cross-functional team responsible for clinical development strategy and execution of studies with the aim of developing new therapies to benefit patients with cancer.

Responsibilities include:

Own the design, delivery and interpretation of clinical studies, ensuring the ethical and scientific integrity of the plans, studies and products in compliance with AZ policies, Good Clinical Practice and regulatory requirements
Lead and develop a team of Medical Directors and Scientist Directors and study design concept delivery within their assigned program of studies
Ensure overall clinical and scientific content for the product or indication(s) aligned to Global Product Team strategy
Setting team vision and goals aligned to therapeutic area leadership and product strategy
With the operations leads, ensuring that the clinical program team rapidly implements new processes, systems and learnings
Through endtoend knowledge of drug development and situational leadership capabilities, promoting and enabling crossfunctional, proactive and solutionsoriented team actions and behaviours
Through integrated understanding of the product strategy, provides strategic clinical and scientific knowledge and support to the Study Physicians and Scientists for initiation, execution and completion of the clinical studies within the assigned portion of the Program
Accountable to represent the company and deliver clinical information / answers to Regulators, Ethic Committees, Marketing Companies, investigators/sites, and provides clarifications as well as solves medical issues in the study team
Under delegation by the Global Clinical Head, provides strategic clinical and scientific knowledge into development decision points and target labelling with insights integrated from advisory boards.
Proactively drives scientific questions and ideas that support clinical hypothesis generation and life cycle management opportunities that generate value for the asset
Maintains uptodate knowledge of the relevant scientific literature, and can clearly communicate key impactful information
Serves as a source of medical and scientific knowledge for the Product Team, in the analyses and interpretation of medical and scientific data

Essential for the role

Life Sciencebased degree at Masters or above (i.e. M.D., PHD, PharmD, Masters in Life Sciencebased area)
Significant (>7 years) clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
Proven track record of successful clinical delivery with demonstrated examples of strategic influence to clinical studies/programs
Ability to form and maintain an excellent reputation outside of AZ, can interact F2F and TC with regulatory agencies, with high credibility in scientific, clinical and drug development competency.
Explores positions and alternatives to reach agreements and solutions.
Presents clear arguments to gain acceptance of ideas and influences outcomes to meet organizational objectives
Good knowledge of biostatistics, Clinical Development, global regulatory environment and pharmacovigilance and working knowledge of medical affairs and payer environment
Proven crossfunctional teamwork and collaboration skills
Excellent presentation skills. Can communicate effectively with internal and external collaborators
Demonstrated leadership qualities with focus on collaborative working skills, trust and openness, irrespective of cultural setting
Agile responsiveness to scientific data. Credible in scientific and commercial environments

Desirable for the role

MD or PhD in scientific discipline
Excellent general medical knowledge
Experience from different organizations
An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence Drug development.
An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements
Line management experience
Demonstrated ability to lead, coach, and mentor junior physicians/scientists.

Why AstraZeneca
With our ground-breaking pipeline, t