Director Medical Diagnostics - Oncology
AstraZeneca

Do you have expertise in, and passion for Medical Affairs in Oncology? Would you like to apply your expertise to impact the Director, Medical Diagnostics role in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

About AstraZeneca

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

About the Oncology Business Unit

A dedicated Oncology unit, this is the place to build a world-class career. Here we are always looking to learn more, welcoming the varied opportunities to expand our horizons or develop niche expertise. Embrace the unparalleled access to industry-leading research, technology and pipeline product launches with a footprint in every region. Coupled with our agility and sharp focus on talent development, there is an exciting opportunity to accelerate a rewarding and meaningful career.

About Gaithersburg
Our Gaithersburg, Maryland facility crafts life-changing medicines for people around the world. This campus employs more than 3,500 specialists in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most ground breaking technology and lab spaces, all designed to encourage collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to fostering a culture of inclusion and collaboration.

The Gaithersburg site offers various amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while strengthening collaboration between teams.

What You'll Do

The Director, Medical Diagnostics - Oncology ensures the timely, high quality input into development and lifecycle plans, to support optimal in-market companion diagnostics / testing solutions to enable optimal treatment throughout the patient journey and to support patient access.

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, evaluate and deliver the US breast cancer diagnostic strategy for current and future oncology products
• Generate diagnostics related insights to shape US input into the development and regulatory approach for new breast cancer oncology portfolio
• Monitor scientific and medical landscape and continue to optimize plans for diagnostic-related needs
• Ensure on-market companion diagnostics excellence for all relevant 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 work 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
• Utilize diagnostics-related evidence for medical education activity e.g., medical evidence, real-world evidence, and epidemiology. 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 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

Minimum Requirements

• Advanced medical or science degree (MD, PhD, PharmD)
• 2+ years of experience in diagnostics or pharma; including US experience
• Experience with breast cancer biomarker testing and general understanding of anatomic pathology testing methods
• Experience with diagnostic test launch planning and evidence generating efforts to support diagnostic test adoption
• Experience with supporting real-world evidence study, testing, and analysis

Preferred Background

• Anatomic Pathology, Oncology Diagnostic or Clinical Laboratory experience, and/or pharmaceutical experience
• An understanding of diagnostic FDA environment, clinical laboratory practices including CLIA lab requirements and diagnostic 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

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.

Where can I find out more?

Our Social Media:

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

#theplacetOBU #oncologycareers #lifeatAZ #Bravedisruptors

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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