Oncology Clinical Development Physician - Cell Therapy
AstraZeneca's is an authority in Oncology with a global footprint and ability to deliver outstanding medicines both small and large molecules to the market. With the new leadership under the unified Oncology R&D, we have prioritized to invest in groundbreaking technology. One area of significant investment is to build internal infrastructure to be a leader in next generation cellular therapy products in Oncology. Using historical expertise in biologics engineering, gene editing and immune expertise across solid and heme malignancies, we are uniquely positioned to develop the best technologies for cellular therapies and is already growing a differentiated pipeline. Backed by senior leadership, the newly formed Oncology Cell Unit will utilize the best expertise within Astrazeneca while allowing for the rapid expansion of cellular therapy research and development.
We are seeking well-trained clinicians with strong leadership skills who are driven by science and the desire to develop novel Cell Therapies. Do you have a mastery of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation and the principles of translational medicine? You will have the opportunity for growth and development while working in a vibrant environment.
We have opportunities at Associate Director / Director / Senior Director levels in accordance with experience. These roles will be based in Gaithersburg, MD, New York City, NY, Boston, MA or Cambridge in the UK.
You will be Managing a team of Clinical Development professionals responsible for delivering against Cell Therapy Drug Development projects. You have full responsibility for the planning, implementation and daily operation of assigned projects. You collaborate with key internal and external partners and may serve as the project Medical Monitor. You contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to optimally deliver our R&D portfolio.
Specific duties and major responsibilities include:
- Direct/Coordinate the design and implementation of early stage clinical projects, as a member of our Product Development Team (PDT) and leader of the Clinical Sub-Team (CST).
- Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development.
- Design scientifically detailed and maximally efficient clinical protocols that are aligned with the clinical development plan.
- Present and defend protocols and development plans at internal governance forums.
- Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical specialist for Phase I/II studies, managing the process from protocol development through individual study report and coordinated regulatory documentation.
- Provide oversight and mentorship to clinical team activities at the PDT, CST, Clinical Trial Team, and Translational Science Sub-Team.
- Monitor study progress, ensure accurate study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team.
- Present study updates, interim results, and final headline data to senior leaders.
- Prepare various documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports. Handle responses to regulatory agencies regarding questions about clinical development issues.
- Ensure that Serious Adverse Events are accurately reported on a global basis.
- Review potential in-licensing candidates and present recommendations to Senior Management groups.
MD or international equivalent is required, and Medical Oncology specialty and sub-specialty training is required, Board Certification is preferred.
- Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology is required.
- Cell Therapy experience is essential. Immuno-therapy experience desirable but not critical.
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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 authorisation and employment eligibility verification requirements.