Global Clinical Program Lead, Cell Therapy, Late Development Oncology

Job Title: Global Clinical Program Lead Late Development Oncology

Hybrid Working: Minimum 3 days per week in the office

Location: Gaithersburg Maryland.

Are you ready to steer late-stage cell therapy programs that can redefine outcomes for patients with prostate cancer This is a chance to transform cutting-edge science into decisive clinical evidence that informs regulators payers and clinicians around the world.

You will lead a significant portion of a complex indication-aligned cluster of studies within a prostate cancer cell therapy program. Partnering with study physicians and clinical scientists you will shape study design oversee conduct and monitoring and drive data interpretation to determine the benefitrisk profile intended label and global value proposition. Can you translate novel biology into pivotal trials that withstand regulatory scrutiny and deliver real-world impact

Working across diverse expert teams and external partners you will co-lead product and study strategy set a clear vision and enable timely decisions. You will leverage innovative toolsfrom biomarkers to advanced trial designsto keep our program competitive and to bring transformative therapies to patients sooner.

Accountabilities:

- Clinical Program Leadership: Set vision and goals for the assigned portion of the program aligned to enterprise and product strategy; own Clinical Program Team deliverables; prioritize clinical activities and enable forward-looking risk mitigation to accelerate milestones and maintain competitive advantage.

- Study Design and Decision-Making: Serve as the single-point accountable leader for the design delivery and interpretation of assigned clinical studies; ensure ethical and scientific integrity; contribute to target product profile clinical plans and labelling decisions often as a delegate of the Global Clinical Head.

- Trial Delivery and Oversight: Drive hands-on delivery for Phase IIIV studies; collaborate seamlessly with global R&D colleagues; identify risks early and implement mitigation to keep trials on time on budget and inspection-ready; when required and medically qualified act as Study Physician.

- External Engagement and Regulatory Interface: Represent the company with regulators ethics committees investigators and alliance partners; provide clear credible clinical responses; build trusted relationships with AROs/CROs and international collaborators; apply strategic intent in interactions with authorities payers and key external experts.

- Scientific Analysis and Evidence Generation: Maintain up-to-date knowledge of relevant literature; deliver balanced statistically robust analyses to inform program decisions; proactively generate scientific questions and lifecycle opportunities that create value for the asset.

- Cross-Functional Ways of Working: Rapidly implement new processes and systems; promote proactive solution-oriented behaviors across sub-teams; enable quick and effective troubleshooting; coach team members to build future talent and high-performing matrix teams; act as PSO lead or delegate for sign-off responsibilities.

- Ethics and Compliance: Uphold the highest ethical standards; ensure compliance with internal SOPs Good Clinical Practice and global/local regulations; when not medically qualified exercise sound judgment to refer specific medical queries to the designated physician.

Essential Skills/Experience:

- Graduate of a recognized school of medicine with an M.D. degree or equivalent or a life science-based degree.

- Prior experience in cell therapy.

- Significant (>5 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.

- 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.

- A clear demonstration of behaviours: Demonstrates AstraZeneca values and Behaviours.

- Agile responsiveness to scientific data; credible in scientific and commercial environments.

Desirable Skills/Experience:

- PhD (or other complementary degree) in a scientific discipline.

- Good 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.

- Demonstrated ability leading and motivating teams in a matrix environment.

- Prior experience in prostate cancer and in early development/translational studies.

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.

Why AstraZeneca:

Here you will lead late-stage programs powered by an expanding toolkit of advanced modalities and biotechnology working in close partnership with diverse experts who move quickly from idea to action. We combine deep scientific rigor with innovative trial approaches data-rich decision-making and true collaborationputting unexpected teams together to spark bold thinking that drives patient impact. Your leadership will shape global strategy inform labels and access and help transform how cancer is treated. We value kindness alongside ambition and provide the platform data and partnerships you need to deliver breakthroughs that matter.

Lead a pivotal chapter in cell therapy for prostate cancerbring your clinical vision and delivery excellence to create measurable patient impact now.

Find out more and follow AstraZeneca on:

LinkedIn annual base pay ranges from $288.059 - 432088. 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.

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; Cambridge UK; Boston Massachusetts and New York City New York.

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.