This opportunity is available at our Gaithersburg, New York City, Boston, South San Francisco, or Cambridge, UK locations.
At AstraZeneca, we are committed to advancing the science of oncology 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 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. We currently have nearly 100 Phase 1, 2, 3 and Lifecycle Management Oncology projects in our robust pipeline. We deliver the Research & Development for Oncology through our Oncology R&D Unit. 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 aims 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 candidate to lead the development and execution of the product strategy for one or more projects. This individual will be accountable for the strategic leadership and execution and act as the champion for the product candidates. The individual will develop a range of strategic and tactical options, secure governance and budget approval, and secure cross-functional resource for the projects and then take accountability for execution, monitoring and reporting of progress / issues. 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 and external experts to develop 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 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.
Major Duties and Responsibilities:
- Leads product 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 strategy and execution of a portfolio of pre-clinical and clinical stage therapies.
- Accountable for the delivery of project according to quality, time, budgets and resources
- Create strategic and integrated 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 stakeholders.
- Lead projects from preclinical Lead Optimisation Investment Decision to clinical Proof of Concept (PoC):
- Responsible for all aspects of project strategy including preclinical, translational, clinical development, patient selection, regulatory, paediatric, 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 manage/mitigate/communicate risk, make decisions, and manage 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 prioritise projects across the portfolio.
- Education: Graduate degree such as M.D. or Ph.D. is required
- 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.
- 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.
- Demonstrated experience leading and motivating teams in a highly matrixed environment.
- Proven record of cultivating and managing internal and external cross-functional collaborations
- Demonstrated organizational and project management skills
- Demonstrated success in influencing colleagues and senior leaders in various departments.
- Must demonstrate high integrity.
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.