Global Clinical Program Lead

AstraZeneca•Gaithersburg, MD

8d•Hybrid

About The Position

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. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives 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. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, you'll be part of a pioneering team dedicated to transforming cancer treatment through innovative approaches. With one of the broadest Oncology pipelines in the industry, you'll have opportunities to work on novel drugs that make a real difference in patient outcomes. Our collaborative environment fosters courage and curiosity, empowering you to take smart risks and challenge norms. We embrace diverse perspectives to tackle tough medical challenges together. Ready to make bold moves in oncology? Apply now to join our mission-driven team!

Requirements

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

Nice To Haves

MD & PhD (or other complementary degree) in scientific discipline
Strong general medical knowledge
An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and factors influencing drug development
An understanding of the interplay between clinical, commercial objectives, drug safety, and regulatory requirements
Demonstrated ability to lead, coach, and mentor junior physicians/scientists

Responsibilities

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.
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.
Maintains up-to-date knowledge of relevant scientific literature.
Delivers analyses of clinical data in a balanced and statistically robust manner.
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.