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Executive Medical Director, Early Clin Dev Oncology Radioconjugate

2 months ago

Gaithersburg, United States AstraZeneca Full time

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 Physician, Oncology Research and Development

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, vibrant environment.

Responsibilities include:

  • Leading a team of Clinical Development professionals, you will work directly with a sub-set of "Discovery" areas which may include areas like Radioconjugate, Immuno-Oncology, Cell Therapy, Anti-body Drug Conjugate, Tumour Driver, DNA Damage Response and Epigenetics Drug Development projects.

  • 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 stakeholders

  • 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 plan.

  • 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 team.

  • 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 global basis.

  • 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 directives.

  • 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 opportunities.

  • 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.

Required Qualifications:

  • 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.

  • 8+ years of experience in clinical research and/or Oncology drug development in pharmaceutical environment.

Desired Qualifications

  • MD/PhD or equivalent

  • Credible with key external oncology stakeholders, payers, and oncology scientific communities

Date Posted

06-Sep-2024

Closing Date

26-Sep-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.PDN-9cf32524-6d6e-43e1-a6c7-ebfbdd05f5e0