Executive Director, Early Clinical Development, Oncology R&D - Physician
Posted on: January 27, 2023
Follow the science to pioneer new frontiers!
Join the team at the heart of AstraZeneca that is committed and
encouraged to follow the science. Driven by our curiosity, passion
and determination we are paving the way to change the practice of
medicine in Oncology.
As leaders of Clinical Development in Oncology, we push the
boundaries of science to change the practice of medicine and
transform the lives of patients living with cancer.
We are a science-based, leading and decisive Oncology enterprise
united in our vision to eliminate cancer as a cause of death. The
pioneers, we make bold moves that transform the way cancer is
treated and truly improve patient outcomes.
With one of the broadest and deepest Oncology pipelines in the
industry, there are many opportunities to work with new and novel
drugs and help discover what's next.
Supportive team players, we draw on diverse knowledge from across
the business and external partners to come to bear on the toughest
medical challenges. Empowered by the business and each other, we
embody courage and curiosity - taking smart risks, challenging the
norm and learning from failures.
Be at the forefront of applying science to studies and using
innovative approaches to create new possibilities. We take an
inter-disciplinary approach including novel biomarkers, AI, novel
endpoints and cutting-edge trial designs to shape the future of our
business and Oncology.
Executive Director, Early Clinical Development, Oncology Research
We are seeking a high performing Executive Director to join our
Early Oncology Clinical Leadership team, working directly with
Discovery areas and managing a team of 6-10 physicians. This is an
opportunity for a well-trained clinician with strong leadership
skills who is driven by science and the desire to develop
innovative therapies for cancer patients. The successful candidate
will have a mastery of the drug development process, notably in
early phase clinical trials, protocol writing, study conduct, data
review and reconciliation, the principles of translational
medicine, and what it takes to lead teams successfully. This role
allows for growth and development while working in a collaborative,
- Leading a team of Clinical Development professionals, you will
work directly with a sub-set of "Discovery" areas which may include
areas like Immuno-Oncology, Cell Therapy, Anti-body Drug Conjugate,
Tumor Driver, DNA Damage Response and Epigenetics Drug Development
- Planning, implementing and managing the daily operation of
assigned drug development projects.
- Participating in Discovery extended leadership teams and
late-stage steering councils.
- Collaborating effectively with key internal and external
- Contributing to and supporting Department/Clinical initiatives
to improve the quality and content of all clinical programs as well
as the cross functional/organization processes designed to
effectively deliver our R&D portfolio.
Examples of typical duties include:
- Direct/Oversee 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). Ensure that the
overall scientific and medical content of all clinical programs is
scientifically and clinically rigorous.
- 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 rigorous and maximally cost-effective
clinical protocols that are aligned with the clinical development
- Present and defend protocols and clinical development plans at
internal governance forums.
- Serve as Medical Monitor, responsible for the safety monitoring
of clinical trials, and as medical expert for Phase I/II studies,
managing the process from protocol development thorough individual
study report and integrated regulatory documentation.
- Provide oversight and guidance to clinical team activities at
the Product Development Team, Clinical Study Team, Clinical Trial
Team, and Translational Science Sub-Team.
- Monitor study progress, ensure proper study conduct and
adherence to the protocol, lead data review, evaluation, and
analyses with support from Data Management and Stats & Programming
- Present study updates, interim results, and final headline data
to senior management as required.
- Prepare various official and regulatory documents for
Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety
and Annual reports, handling of responses to regulatory agencies
regarding questions about complex clinical development issues
(e.g., safety or efficacy).
- Ensure that Serious Adverse Events are properly reported on a
- Lead cross-functional teams comprised of multidisciplinary
professionals and clinical scientists. Direct responsibility for
leading a team of Clinical Development professionals and ensure
delivery of their portfolio of assets.
- Implement clinical R&D policies, SOPs and related
- Review potential in-licensing candidates and present
recommendations to Senior Management groups.
- Support any needed due diligence and prepare/present medically
sound strategy and plans associated with advanced
- Contribute 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 effectively
deliver our R&D portfolio.
- MD or international equivalent is required
- Medical Oncology specialty and sub-specialty training is
required, Board Certification is preferred.
- Clinical or research experience (in an academic or
pharmaceutical environment) related to the design and/or conduct of
clinical studies in oncology is required.
- Significant experience in clinical research and/or Oncology
drug development in pharmaceutical environment.
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.
AstraZeneca has taken critical steps to protect colleagues, loved
ones, and patients from COVID-19 and its variants. Accordingly,
AstraZeneca requires all US employees to be fully vaccinated for
COVID-19 prior to the first date of employment. AstraZeneca will
consider requests for reasonable accommodations as required by
Keywords: AstraZeneca, Washington DC , Executive Director, Early Clinical Development, Oncology R&D - Physician, Healthcare , Gaithersburg, DC
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