Executive Director, Head of Cell Therapy Non-Clinical Safety Lead, Cell Therapy Translational and Safety Sciences.

AstraZeneca•Gaithersburg, MD

8d•Hybrid

About The Position

At AstraZeneca, we’re building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. We believe in the potential of our people, and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to ensure realization of your potential. You’ll join an energized team and work on projects that offer a wide range of on-going learning and career development opportunities. Are you passionate about shaping the future of Cell Therapy? We are seeking an entrepreneurial leader to head our Nonclinical Safety Sciences team in our new global multi-functional Cell Therapy Translational and Safety Sciences group. As the Nonclinical Safety Sciences Head, you will play a crucial role in bringing the next generation of innovative life-changing medicines to patients. You will oversee a team of toxicologists and laboratory-based specialists to influence and enable the design and development of safe cell therapies across multiple modalities and therapeutic areas. You will report to the VP of Cell Therapy Translational and Safety Sciences (CT-TSS) and will become a member of the CT-TSS Leadership Team contributing to both, strategy and operational discussions and initiatives.

Requirements

PhD relevant field (Toxicology, Biology, Immunology) with over 10 years of experience.
Excellent understanding of nonclinical safety sciences in the context of CAR-T & TCR cell therapies and proven prior experience in the field.
Extensive experience supporting nonclinical safety assessments of cell therapies, including different modalities and platforms (autologous, allogeneic, in vivo, etc), from target identification through clinical development.
Experience of global IND / BLA / IIT submissions, leading regulatory interactions within area of expertise and responding to global regulatory questions.
Proven and excellent experience in designing, developing and implementing cell therapy safety strategies.
Strong leadership skills and line management experience with a positive team engaging attitude and a track record in the leadership, management and talent development of individuals and teams.
Track record of leading impact on drug R&D within the pharmaceutical industry or biotech sector with a strong focus on safety assessment.
Leader of collaborations with academia, biotech and / or pharma industry to enhance pre-clinical safety assessment of T-cell therapies.
Track record of scientific innovation in the safety assessment arena
Recognized as a leader and influencer in the cell therapy field with proven track record of publishing relevant results and tools in journals, conferences, and other scientific proceedings.

Responsibilities

Lead global team of toxicologists and laboratory-based specialists to design and deliver safe cell therapies, across different platforms (autologous, allogeneic, in vivo), engineered with CAR-T and TCR-T, and across therapeutic areas.
Ensure appropriate resource allocation and program and project prioritization for timely delivery towards a dynamic and expanding cell therapy portfolio. Provide oversight and guidance to enable project and portfolio investment decisions.
Lead and manage talent development, recruitment and evaluate team performance on a regular basis. Promote inclusion and diversity to build high-functioning teams within and across departments. Align to AZ’s culture and values and further solidify our reputation as a great place to work.
As a seasoned subject matter expert in Nonclinical Cell Therapy Safety, use experience, expertise and leadership to influence Cell Therapy Safety Science project strategies. Anticipate and manage potential project-related nonclinical safety concerns and support global regulatory submissions and health authority requests.
Be responsible and accountable for Cell Therapy Safety Sciences strategy and deliverables.
Build and promote collaborative and inclusive networks and workstreams to ensure alignment with key global stakeholders.
Initiate, lead and manage internal and external collaborations to access latest scientific developments and innovations, expanding business opportunities for the company resulting in enhanced impact and external scientific leadership in the field of cell therapy.
Performs business development-related asset, platform or technology evaluations.
Perform evaluation and due diligence for in licensing, out-sourcing or collaboration opportunities.
Contribute to wider scientific strategy on cell therapy within the Cell Therapy Enterprise and cross-functionally with relevant partners in AZ.