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 youll 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. Youll 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 youll 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 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

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 youll be part of a pioneering team dedicated to transforming cancer treatment through innovative approaches. With one of the broadest Oncology pipelines in the industry youll 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!

This Global Clinical Program Lead role is posted in Gaithersburg United States although we are willing to consider candidates in these Late Oncology locations: Mississauga Canada Warsaw Poland; Barcelona Spain and Cambridge UK.

The annual base pay ranges from 280895.20 - 421342.80 Hourly and salaried non-exempt employees will also be paid overtime pay when workingqualifying overtime pay offered may vary depending on multiple individualized factors including marketlocation job-related knowledge skills and addition our positions offer a short-term incentive bonusopportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles)to receive aretirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included aqualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits includingmedical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicableplans. Additional details of participation in these benefit plans will be provided if an employee receives an offer ofemployment. If hired employee will be in an at-will position and the Company reserves the right to modify basepay(as well as any other discretionary payment or compensation program) at any time including for reasons related toindividual performance Company or individual department/team performance and market factors.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.