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Director, Medical Diagnostic - Her2 at AstraZeneca

Posted in Other 30+ days ago.

Location: Gaithersburg, Maryland





Job Description:

A dedicated Oncology unit, this is the place to build a world-class career. AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm with the bold ambition to eliminate cancer as a cause of death. We are proud to work on ground-breaking science with one of the broadest and deepest Oncology pipelines in the business.


The Director, Medical Diagnostics - Oncology ensures the timely, high quality input into development and lifecycle plans, to support optimal companion diagnostics / testing solutions to enable optimal treatment throughout the patient journey and to support patient access. This role is within US Medical Affairs supporting the Enhertu Oncology Franchise.


An important element of this role is therefore to develop strategic and long-term partnerships with relevant oncology stakeholders and decision makers in the complex oncology ecosystem including with the core medical teams, development organization and global medical teams, based on a deep scientific understanding of the testing environment and the pathology of the tumor/micro-environment and the medical and clinical operational issues on the disease and testing pathway, enabling the organization to help develop tailored testing solutions to be developed.



Major Responsibilities



  • Develop diagnostic medical strategy


  • Develop, evaluate and deliver the US Enhertu diagnostic strategy for the current and future oncology products


  • Generate diagnostics related insight to shape US input into the development and regulatory approach for the breast and lung portfolio


  • Monitor scientific and medical landscape and continue to optimize plans for diagnostic-related needs


  • Ensure in-market companion diagnostics / testing excellence for all product launches, including market readiness evaluation to inform go/no go decisions


  • Deliver education to internal and external stakeholders


  • Support testing by impacting the testing environment


  • Support in-market registration/regulatory approval of future companion diagnostics / other testing solutions as required


  • Identify issues in current testing landscape and working with external stakeholders to develop solutions to remove or minimize diagnostic barriers to therapy use, e.g., by optimizing testing pathways


  • Connectivity to external experts/advocacy/regulatory and pathway organizations to understand evolving landscape and anticipate future changes to US landscape


  • Develop and help drive appropriate educational programs


  • Utilize diagnostics related evidence for medical education activity (e.g., medical evidence, real-world evidence and epidemiology) and identify evidence gaps for local plans, develop data generation approach in collaboration with Core Medical Teams, and ensure quality input into data generation approaches/proposals.


  • Develop strategic partnerships


  • Develop scientific leadership with companion diagnostics partners, advocacy, scientific organizations and thought leaders across oncology to help inform and develop best in class diagnostics capabilities aligned with the medical needs of the portfolio. Identify and collaborate with national diagnostic and clinical opinion leaders and societies to identify, design and execute appropriate activities to optimize the provision of diagnostics.


  • Remove barriers to testing through collaborative partnerships with diagnostic companies, lab networks, Key opinion leaders (KOLs)s and Health Care Professionals (HCPs)




Minimum Requirements


  • Advanced medical degree (MD, PhD)


  • 3+ years of experience in health care deliver; including US experience and preferably oncology diagnostic or clinical lab experience, pharmaceutical experience is a plus


  • Experience with diagnostic test launch planning and evidence generating efforts to support diagnostic test adoption




Preferred Background


  • Proven experience with a broad base of external experts including prescribers, payors, and providers. A track record of effective management of decision-making bodies and governance


  • An understanding of diagnostic FDA environment, clinical laboratory practices including CLIA lab requirements and test implementation


  • Proven track record of strategic thinking, judgment and influencing skills, Strong leadership attributes to set direction, generate commitment, balance short and long-term needs, constructively resolve issues


  • Proven demonstration of effective cross-functional project team leadership


  • Ability to lead and influence through change


  • Strong teamwork and collaboration skills





Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours. Apply today.


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 follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.


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 requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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