Oncology Director, Medical Diagnostic -HER 2
US Medical Affairs Director, Medical Diagnostic - HER2
Change the way cancer is treated by making an impact at every point in the patient journey. We are thinking and acting faster than anyone to ensure the data we’re producing helps physicians care for patients better. To ultimately deliver clinical promises to the real world, improve patient outcomes and their quality of life.
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
About AstraZeneca in Gaithersburg, MD
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts 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 cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity 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 workspaces to suit a variety of working styles while increasing collaboration between teams.
Summary of the Group and Role
In Medical Affairs, we change the practice of medicine and improve the patient experience by generating and communicating compelling medical evidence. We translate the wealth of medical and scientific expertise to ensure the data we produce helps physicians to better treat patients at every point in the journey. Valued partners across the enterprise, we rely on working together and sharing knowledge to combine science and strategy in a way that advances our pipeline and progresses our journey to redefine cancer treatment. A high-performing team within a global, growing organization – our culture is one of openness and transparency, fused with ambition and drive. A supportive and trusting place to grow your career, each of us is empowered to take a tailored approach to our development, driving the pace and direction. Come and be part of a talented, cross-functional team working together to improve lives and make the biggest possible impact for patients, science, and society.
What you’ll do
The US Medical Affairs Director/Sr. Director, Medical Diagnostics – Oncology ensures the timely, high-quality input into the development and lifecycle plans, to support optimal companion diagnostic/testing solutions to enable optimal treatment throughout the patient journey and to support patient access. This role is within US Medical Affairs supporting the Oncology Franchise. This will involve diagnostics for our evolving robust HER2 pipeline.
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.
Develop a diagnostic medical strategy
Develop, evaluate and deliver the US HER2 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 IO 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
Support in-market registration/regulatory approval of future companion diagnostics/other testing solutions as required
Identity 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
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 for DDR.
Remove barriers to testing through collaborative partnerships with diagnostic companies, lab networks, Key opinion leaders (KOLs)s and Health Care Professionals (HCPs)
Essential for the role
Advanced medical degree (MD, Ph.D.)
3+ years of experience in health care delivery; 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
Desirable for the role
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
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.
So, what’s next?
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
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
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 authorisation and employment eligibility verification requirements.