Global Clinical Program Lead, Late Development Oncology

Introduction to role:

Are you interested in pushing the boundaries of science and transform the lives of patients living with cancer? As a Global Clinical Program Lead, you'll be accountable for a significant portion of a late development oncology clinical program. This role involves managing complex clinical studies, often requiring collaboration with third parties, and demands strategic thinking and entrepreneurial spirit to maintain a competitive edge. You'll work closely with study physicians to design, conduct, monitor, and interpret data from clinical studies, ensuring they meet global market needs. As a catalyst for new ways of working, you'll lead process improvement projects and mentor staff, shaping the future of oncology clinical development.

Accountabilities:

• Overall clinical and scientific content for the product or indication(s) aligned to GPT strategy.
• Sets team vision and goals aligned to TALT and product strategy.
• With the DCD, ensure the CPT rapidly implements new processes, systems, and learning.
• Prioritization of clinical activities within the clinical program and ensures forward-looking risk mitigation strategies.
• Promotes cross-functional, proactive, and solutions-oriented team actions through end-to-end knowledge of oncology drug development.
• Enables quick and effective troubleshooting within the CPT and its associated sub-teams.
• Mentors individual team members as needed, building future AZ talent through the matrix team model.
• Single point accountable leader for the design, delivery, and interpretation of clinical studies ensuring ethical and scientific integrity.
• Accountable for late phase study designs and study design concept delivery within their assigned oncology program of studies.
• Provides strategic clinical and scientific knowledge to Study Physicians for initiation, execution, and completion of clinical studies.
• Represents the company and delivers clinical information/answers to Regulators, Ethic Committees, Marketing Companies, investigators/sites.
• Provides strategic clinical and scientific knowledge into development decision points/TPP/TPC and target labeling.
• Works as a delegate of the Global Clinical Head across several oncology studies.
• Can be the clinical representative on Global Product Teams for the assigned part of the program.
• Ability to form and maintain an excellent reputation outside of AZ.
• Trial conduct and hands-on delivery accountabilities
• Accountable to GCH or delegate for significant clinical aspects and design/delivery of studies.
• Collaborates seamlessly with global colleagues at other R&D sites.
• May be accountable for identifying risks and proposing mitigation strategies for successful Phase II, III or IV studies.
• Scientific clinical analytical accountabilities
• Maintains up-to-date knowledge of relevant scientific literature.
• Delivers analyses of clinical data in a balanced and statistically robust manner.
• Functional and Project Leadership
• Significant role in shaping the function through idea generation and leading improvement projects.
• Seen as a role model in their function, providing hands-on coaching and mentoring to staff.

Essential Skills/Experience:

• Life Science-based degree at masters or above (i.e. M.D., PHD, PharmD, Masters in Life Science-based area)
• 7+ years clinical research expertise in oncology clinical development including study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
• Strong knowledge and understanding of the Oncology therapeutic area with experience in diverse biological mechanisms.
• Proven track record of successful clinical delivery with demonstrated examples of strategic influence to clinical studies/programs
• 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 cross-functional teamwork and collaboration skills
• Excellent presentation skills. Can communicate effectively with internal and external collaborators

Desirable Skills/Experience:

• MD & PhD (or other complementary degree) in scientific discipline
• Experience in radioconjugate clinical development programs
• Late phase development experience preferred, especially within prostate cancer indications
• Strong general medical knowledge
• An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and factors influencing dr