Head of Medical Diagnostics, US Medical Affairs Oncology
AstraZeneca

Gaithersburg, Maryland

Posted in Pharmaceuticals
29 days ago



Job Description

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As Head of Medical Diagnostics, US Medical Affairs Oncology, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing practice and patients' lives.

AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through five key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, HER2 and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.

The Head of Medical Diagnostics, US medical affairs Oncology, leads a team of tumor-specific US Medical Diagnostic Directors to develop and execute medical diagnostic strategies including diagnostic evidence and communications to drive best clinical practices as a key component of AstraZeneca's precision medicine patient centric approach.

As a key member of the US Medical Affairs Leadership Team (MALT), it is the responsibility of the Head of Medical Diagnostics to ensure the development and execution of above-tumor and tumor-specific medical diagnostic strategies for AstraZeneca's in-market and pipeline precision medicine products, requiring collaboration with relevant internal and external oncology stakeholders and decision makers in the complex oncology ecosystem. This would include establishing excellent working relationships with external diagnostic thought leaders and organisations, US Medical Franchise Heads, US Medical Heads, wider US cross-functional medical affairs functions, US commercial marketing teams, US Precision Medicine team as well as related and appropriate functions within Research & Development and Global OBU Medical Affairs.

The candidate must have a deep scientific understanding of the testing environment and pathology workflow, including the medical and clinical operational issues of the diseaseand testing pathway.

Major Responsibilities:

  • Act as core strategic member of US MALT providing leadership and direction to US Medical Affairs
  • Lead a team of US Medical Diagnostic Directors
  • Ensure appropriate talent acquisition, development and retention within own area of responsibility
  • Ensure the development and delivery of Diagnostic Medical Diagnostic strategies as highlighted below:


Develop diagnostic medical strategy, deliver internal and external education:
  • Help evaluate, develop and deliver the national diagnostic strategy for current and future Astrazeneca oncology products
  • Generate diagnostics-related insights to shape U.S. input to lifecycle planning from product development through regulatory filing, launch and post launch commercialization
  • Monitor scientific and medical landscape 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
  • Educate internal and external stakeholders on the value of biomarker testing and best practices in implementing testing into clinical practices for optimal patient care


Support testing by impacting the testing environment:
  • Generate robust evidence, through AstraZeneca studies, external scientific research or RWD/RWE, to support the value of biomarker testing in precision medicine, especially for new markers, new testing modalities, new disease indications and/or patient population
  • Develop data generation approach in collaboration with Core Medical Teams, HEOR teams, and ensure quality input into data generation approaches/proposals
  • Support in-market registration/regulatory approval of future companion diagnostics / other testing solutions as required
  • Identify issues in current testing landscape and work with stakeholders to develop solutions to remove or minimize testing barriers to precision medicine.
  • Connect with external experts/advocacy/regulatory and pathway organizations to understand evolving landscape and anticipate future changes to US diagnostic landscape
  • Utilize diagnostics related evidence for medical education activity (e.g., medical information, real-world data/epidemiology, certified education), and identify evidence gaps for global or local plans
  • Demonstrate scientific leadership by collaborating 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


Minimum Requirements
  • Advanced medicaldegree or PhD (molecular pathologistpreferred)
  • 7+ years of experience in health care delivery; including US experience and preferablyoncology diagnostic or clinical labexperience, pharmaceutical experience is a plus


Preferred Background
  • Proven experience with a broad base of external experts includingprescribers, payers, providers and track record of effective management of decision-making bodies and governance
  • Deep 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, i.e., influencing national internal teams and customers to ensure strong commercial focus with excellent execution
  • Strong leadership attributes to set direction, generate commitment, balance short- and long- term needs, and constructively resolve issues
  • Proven demonstration of effective cross-functional project team leadership
  • Ability to lead and influence through change
  • Strong teamwork and collaboration skills


Next Steps - Apply today!

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