Global Clinical Program Lead- Late Development

hace 1 mes

Barcelona, España AstraZeneca A tiempo completo

Do you have expertise in, and passion for clinical drug development? Are you looking to transform the way cancer is treated and truly improve patient outcomes? Driven by our curiosity, passion and determination we are paving the way to change the practice of medicine in Oncology

AstraZeneca’s Oncology Research and Development teams push the boundaries of science, changing the lives of patients living with cancer. Our Clinical Development teams are united around our vision to eliminate cancer as a cause of death. Late Clinical Development is accountable for late phase drug development activities related to late-stage trials leading to drug approval by regulatory agencies, including phase 2 and 3 clinical trials.

As a Global Clinical Program Lead, you will work cross functionally to support the design, conduct, monitoring and data interpretation across a cluster of indication-aligned studies. GCPLs are strategic and patient focused, generating opportunity with an ambitious approach to maintain a competitive advantage. This role is applied to portions of the program that have the highest degree of complexity based upon the known science or the size of the program and may also include a third-party collaboration. You will ensure that the data collected within the studies allows the determination of the benefits and risks of the compound and meet the needs of the intended label indication and price in markets globally.

**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 guidelines
- Ensure overall clinical and scientific content for the product or indication(s) aligned to Global Product Team strategy
- Represent the company to investigators and sites, regulators, ethic committees, marketing companies to by delivering clinical information, providing clarification and resolving medical issues with the study team
- Provide strategic knowledge and support to the Medical Directors and Development Scientists for initiation, execution and completion of the clinical studies
- With the GCH, provide strategic feedback on development decision points and target labeling
- Drive scientific questions and ideas that support clinical hypothesis generation and program management opportunities that generate value
- Serve as a resource for the Product Team, in the analysis and framing of medical and scientific data
- Mentor and support development of a matrixed team of Study Physicians and Scientist Directors

**Essential Qualifications**
- Life Science-based degree at masters or above (i.e. M.D., PHD, PharmD, Masters in Life Science-based area)
- Expertise in Lung Cancer
- Significant (>7 years) clinical development expertise in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
- Consistent record of successful clinical delivery with proven examples of strategic influence to clinical studies
- Ability to form and maintain an excellent reputation outside of AZ, can interact F2F and TC with regulatory agencies, with high level of credibility
- Good knowledge of biostatistics, Clinical Development, regulatory and pharmacovigilance as well as knowledge of medical affairs and the payer environment
- Proven cross-functional teamwork and collaboration skills
- Excellent presentation and communication skills and agility with scientific data to support interactions with internal and external collaborators, in scientific and commercial environments
- Demonstrated leadership qualities with focus on collaborative working skills, trust and openness, irrespective of cultural setting

Desirable for the role
- Excellent general medical knowledge
- An understanding of pharmaceutical industry R&D and the factors which influence drug development
- Ability to enhance outcomes with an understanding of the interplay between clinical, commercial, drug safety and regulatory requirements
- Demonstrated ability to coach, and mentor junior physicians/scientists

**In-office Requirement**:When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
- The annual base_ _pay_ _(or hourly rate of compensation) for this position ranges from $_ 265,780.80 - 398,671.20_. Hourly and salaried non-exempt employees will also be paid overtime_ _pay_ _when working qualifying overtime hours. Base_ _pay_ _offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and e

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