Global Clinical Program Lead, Cell Therapy

This opportunity is available at our Gaithersburg, MD and Waltham, MA and locations.
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. We are more than one of the world's leading pharmaceutical companies.
AstraZeneca has a multifaceted environment that cultivates collaboration and innovation. We attract top minds, and we nurture and build talent.
Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy and Epigenetics) to help address unmet clinical needs in a host of hematological cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death. This unit has responsibility for the value chain from discovery through to late-stage development, enabling rapid acceleration of promising early-stage assets and life-cycle management programs.
The Hematology Research and Early Development (R&D) team has the accountability for all drug development activities in hematology research from first in man studies, all the way to late-stage trials leading to drug approval by regulatory agencies (Phase 1, 2 and 3 trials). The team strives to deliver compelling preclinical, clinical and translational data packages providing confidence in the dosing strategy, tolerability profile and therapeutic efficacy of our candidate drugs to support investment in late stage clinical development, leading to drug approval.
We are looking for a highly qualified Global Clinical Program Lead (GCPL) candidate to lead the clinical development and execution of the product strategy for multiple projects. This individual will be accountable for the strategic clinical development plan and clinical execution of the compounds and reports to the Global Clinical Head (GCH) of the disease indication. The individual will articulate the project goals, strategy and the underlying science and clinical need to internal and external audiences with clarity and credibility.
In this role the candidate will work with other project leaders, scientific and clinical leaders as well as external experts to coordinated integrated project plans which can be delivered across functional boundaries. The candidate will ensure that diverse views within the team are heard and that a strongly empowered and motivated team is created, and will demonstrate highly visible leadership within the oncology community, both within AZ and externally. The successful candidate will have hematology/oncology/Cell Therapy clinical drug development experience, demonstrated leadership, and be able to critically navigate the science that underlies these programs. The candidate should be able to effectively communicate across a broad range of audiences and have an ability to clearly articulate project specific strategies as well as the overall oncology strategy.

• Leads clinical development teams responsible for novel Hematology Oncology therapies from preclinical candidate selection through proof of concept leading to Phase 3 investment decisions. The candidate will lead all regulatory submissions. Accountable for the clinical strategy and clinical execution of a portfolio of pre-clinical and clinical stage therapies.
• Accountable for the delivery of project according to quality, time, budgets and resources
• Build strategic and coordinated product development plans which are aligned with business objectives and are differentiated from competitor products.
• Accountable for the execution of the integrated product plan to agreed scope, timelines, and budgets
• Leads and communicates the project development strategy at governance meetings, accountable for aligning with internal management and for communicating with external collaborators.
• Lead projects from preclinical Lead Optimization Investment Decision to clinical Proof of Concept (PoC):
• Responsible for all aspects of project strategy including preclinical, translational, clinical development, patient selection, regulatory, pediatric, intellectual property, CMC and Asian development strategy
• Development of the Target Product Profile, ensuring alignment with disease area strategy and late stage development
• Leads the Product Development Team (PDT) to effectively run/mitigate/communicate risk, make decisions, and handle conflict and change.
• Responsible for maintaining a high degree of PDT effectiveness through collaboration, influence, and, as necessary, coaching and mentoring of cross-functional team members.
• Ensure that there are robust processes, plans and data to enable Governance Bodies to make investment decisions and prioritize projects across the portfolio.

Minimum Qualifications:

• M.D. is required
• A minimum of 7 years of relevant experience
• Industry experience in drug development including experience in early and late phase drug development and regulatory knowledge.
• Strong knowledge and understanding of the Hematology Oncology therapeutic area with experience in diverse biological mechanisms.
• Experience with cellular therapy preferred
• Broad understanding of the evolving clinical landscape in hematology/oncology
• Lead the overall development of project strategy and be accountable for project plans, timelines, progress, and outcomes.
• Proven experience mentoring and motivating teams in a highly matrixed environment.
• Proven record of encouraging and leading internal and external cross-functional collaborations
• Demonstrated organizational and project management skills
• Proven success in influencing colleagues and senior leaders in various departments.
• Must demonstrate high integrity.

Working at AstraZeneca
Here you'll have the chance to create a substantial difference to patients' lives! With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines - for the world's most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem.
Next Steps? Apply now!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Find out more and follow AstraZeneca on:
LinkedIn https://www.linkedin.com/company/1603/
Facebook https://www.facebook.com/astrazenecacareers/
Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
Date Posted
28-Feb-2024
Closing Date
27-Mar-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.