AstraZeneca GmbH
Director, Clinical Diagnostics - Global Oncology Diagnostics
AstraZeneca GmbH, Baltimore, Maryland, United States,
The Director of Clinical Diagnostics, Global Oncology Diagnostics is accountable for the development and execution of global scientific strategy related to pathologic diagnosis, including Digital and Computational Pathology and Molecular Pathology, for AstraZeneca oncology diagnostic solutions worldwide. This role supports the mission of AstraZeneca Oncology in four domains:
Maximizing Global Biomarker Adoption and facilitating the development of local testing solutions
Generating Clinical Evidence in collaboration with Oncology Medical Affairs
Developing Medical Education for the lab community to support the adoption of local testing
Leading efforts for the generation of Real World Data for Pathology diagnostic solutions
Accountabilities
The Director of Clinical Diagnostics will work closely with cross-functional partners, regions, and countries for coordination of all Oncology diagnostic activities. The role involves collaborating on the development of the global medical plan for patient identification solutions for AstraZeneca Oncology products and partnering with all relevant cross-functional collaborators to implement the Oncology Diagnostics medical strategy. The role also includes assisting in the development of KEE advocacy and KEE engagement plans in laboratory segments, leading Scientific Advisory boards and other diagnostics activities at scientific events including major Congresses and Forums.
Essential Skills/Experience
MD/DO degree from an accredited medical school or PhD
5 years of experience in medical affairs, global diagnostics, biopharmaceutical industry, and/or academia.
Desirable Skills/Experience
MD plus accredited pathology residency; fellowship in a clinical or molecular subspecialty
Strong foundation in Life Sciences e.g. Molecular Biology, Pathology
Experience with clinical companion diagnostic development
Membership in diagnostics professional societies
5+ years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
Experience with stakeholder engagement and interactions (KEE, advocacy groups, payers)
Familiarity with global regulatory organizations, guidelines, and practices
Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs specifically related to companion diagnostics
Track record of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issues
In-depth understanding of scientific method and clinical applications based on medical, scientific, and practical rationale
Track record of success collaborating in matrixed cross-functional teams
Outstanding written and verbal communication skills
At AstraZeneca, we are driven by a bold ambition to eliminate cancer as a cause of death. Our fast-paced environment encourages innovation and quick decision-making. We foster a culture where everyone can be themselves and contribute to our mission. By joining us, you will be part of a team that is transforming cancer care through pioneering research and cutting-edge technology.
Ready to make a difference? Apply now to join our team!
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