Director, Clinical Diagnostics - Global Oncology Diagnostics

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 solutionsGenerating Clinical Evidence in collaboration with Oncology Medical AffairsDeveloping Medical Education for the lab community to support the adoption of local testingLeading efforts for the generation of Real World Data for Pathology diagnostic solutionsAccountabilitiesThe 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/ExperienceMD/DO degree from an accredited medical school or PhD5 years of experience in medical affairs, global diagnostics, biopharmaceutical industry, and/or academia.Desirable Skills/ExperienceMD plus accredited pathology residency; fellowship in a clinical or molecular subspecialtyStrong foundation in Life Sciences e.g. Molecular Biology, PathologyExperience with clinical companion diagnostic developmentMembership in diagnostics professional societies5+ years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payersExperience with stakeholder engagement and interactions (KEE, advocacy groups, payers)Familiarity with global regulatory organizations, guidelines, and practicesKnowledge of Good Clinical Practices (GCP) and global regulations and guidelinesKnowledge 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 diagnosticsTrack record of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issuesIn-depth understanding of scientific method and clinical applications based on medical, scientific, and practical rationaleTrack record of success collaborating in matrixed cross-functional teamsOutstanding written and verbal communication skillsWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.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!#LI-HybridDate Posted06-Dec-2024Closing Date07-Jan-2025Our 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.SummaryLocation: US - Gaithersburg - MDType: Full time