The Precision Medicine Franchise Lead Immuno-Oncology (IO) is accountable that companion diagnostic tests and precision medicine solutions are delivered to the IO drug product teams and programs. The role holder will achieve this by drawing on confirmed, world-class expertise and experience in companion diagnostic development, drug development and Companion Diagnostics regulatory approval processes across the major markets. The role holder ensures the adoption and implementation of optimized precision medicine approaches within the relevant R&D Unit/Franchise, by closely working with relevant collaborators across Oncology R&D and by providing leadership for Diagnostic Leads and Diagnostic Sub-teams to deliver and implement an optimized and agreed diagnostic strategy for each of the IO drug development programs.
The Head of the PMB Immuno-Oncology (IO) Franchise leads a global cross-functional team across PMB (Precision Medicine and Biosamples) and other global functions including IO Precision Medicine Leads and Global Product Team (GPT) Diagnostic sub-teams, and is accountable to the PMB Leadership team and Oncology R&D teams and governance leaders. The role holder contributes as the highest scientific and Diagnostic technology level for ground-breaking development and strategic investment that impacts broadly across Oncology R&D’s registrational drug portfolio and increases patient access to AstraZeneca drugs in clinical trials and on the market, and ensures that companion diagnostic development for products within the therapeutic area reflects world-class practice in the field and contributes to increased probability of successful drug launch, reimbursement and return on investment
The role holder provides input to the global PMB strategy, leads technical advice in specific area of expertise and diagnostic initiatives to improve quality, integrity and efficiency of work performed within PMB, and improving patient access to AstraZeneca drugs, as well as ensures effective performance, succession planning, recruitment and retention of team members.
The Precision Medicine Franchise Lead works collaboratively with colleagues at all levels within the home function, across AstraZeneca and with external partners. As a leader of PMB, the role holder is accountable for ensuring that the roles and responsibilities of the function are delivered demonstrating behaviors and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures; including accountability for compliant management of Budget, Safety, Health and Environment.
Ensure the adoption of precision medicine strategies within the R&D Unit to meet the needs of patients, payers, physicians and contribute to drug products
Acquire and lead strategic investment to enable companion diagnostic development for the therapeutic area, based on a forward-looking, externally-focused view of the field
Deliver expert advice of high scientific quality on strategic direction for precision medicine approaches and diagnostic development to leadership teams within the relevant therapeutic area
Craft the external environment (e.g. government and regulatory interactions) to address barriers and facilitate diagnostic development relevant to the therapeutic area
Provide strategic leadership, including communication of a clear and inspirational strategic vision. Attract, recruit, and retain top talent and technical expertise.
Lead performance management and personal development of team members through coaching, mentoring, and motivating.
Supervise and ensure compliance with all AstraZeneca Policies and Standards and immediately address instances of non-compliance.
Build and implement strategy for the delivery of diagnostic tests for use in clinical trials and across the portfolio, regulatory submission and commercialization based on a long-term view of internal project demand and the evolving external environment.
Draw upon previous experience and expert knowledge to provide a relevant knowledge base of companion diagnostic development and competitive intelligence. Mentor team members to ensure skills development and provision of expert knowledge
Accountable for up to $100m multiple-project budget per annum. Indirectly responsible for the success of the associated drug products (estimated $1bn each)
Ensure delivery of objectives, project plans, financial investments and milestones for companion diagnostic delivery to all products within the relevant therapeutic area with the Heads of PMB and relevant R&D Unit
Accountable for the delivery of companion diagnostic plans to time, budget and quality
Provide updates on all PMB activities in the therapeutic area for progress, risks, issues and opportunities to governance bodies for review, challenge and issue resolution
Work with functional representatives to resolve resource, quality and budget issues
Ensure that members of the Diagnostic project teams handle risk in an appropriate and compliant manner
Provide metrics to senior leaders and to governance bodies (e.g. Early Stage Product Committee (ESPC) or Late Stage Product Committee (LSPC)) as required
Ensure that all governance issues are identified and reported appropriately
Minimum Qualifications:
PhD in a relevant subject
Confirmed delivery of companion diagnostic tests or segmentation tools through regulatory submission and launch, within a diagnostic or pharmaceutical setting
Demonstrated substantial scientific and business experience of Precision Medicine and diagnostic development approaches within the relevant therapeutic area
Broad understanding of CDx regulations in US, EU, Japan and China and proven global regulatory interactions
Substantial (10+ years) experience in drug development, diagnostic development and regulatory interactions
Evidence of excellent skills in communication, stakeholder management and influencing, program management
Effective global leadership, performance management and talent management
Comprehensive understanding of the functions involved in companion diagnostic development and how they contribute to achieving the objectives of the business
Desired Qualification:
Significant experience in similar role in different companies
Delivery of multiple examples of companion diagnostics, regulatory interactions (particularly with FDA) and commercialization
High quality scientific expertise in the precision medicine field relevant and therapeutic area as evidenced by publications and external reputation
Evidence of crafting the companion diagnostic field e.g. diagnostic partnering, regulation of drugs and linked diagnostics, payer and policy considerations, ethical and legal aspects
Led Precision Medicine critical initiatives in similar roles
This role can sit at our Gaithersburg, MD or Cambridge, UK location
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 groundbreaking 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.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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Date Posted
07-Mar-2023Closing Date
29-Mar-2023AstraZeneca 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.