AstraZeneca
Director Medical Diagnostics, Hematology
AstraZeneca, Gaithersburg, Maryland, us, 20883
The Director, Medical Diagnostics Hematology 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 Heme Oncology Franchise.
An important element of this role is therefore to develop strategic and long-term partnerships with both internal and external 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 for the US market.
Equally important, the candidate will partner strategically with several field functional areas across AZ US Oncology including but not limited to Medical Science Liaisons (MSLs), Scientific Project Medical Director (SPMD) team and precision medicine managers (PMM) for strategic planning and project execution. These external collaborations will be grounded in the aim to drive biomarker testing at select health systems across the United States.
Major Responsibilities
Accountable for the Heme medical Dx strategy and oversee creation and delivery of the Dx plan per indication within the heme indications. Develops the Dx plan of the Integrated Medical Affairs Plan for each assigned brand ensuring that specific annual objectives and milestones are set to enable the achievement of the longer term medical strategy.
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.
Deliver diagnostic education to internal and external stakeholders, including internal training.
Identify issues in current testing landscape and work with external stakeholders to develop solutions to remove or minimize diagnostic barriers to therapy use through collaborative partnerships.
Minimum Requirements
Advanced medical degree (MD, PhD).
3+ years of experience in health care delivery; including US experience and preferably hematology diagnostic or clinical lab experience.
Past pharmaceutical company experience working in a matrix environment is a requirement.
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.
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An important element of this role is therefore to develop strategic and long-term partnerships with both internal and external 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 for the US market.
Equally important, the candidate will partner strategically with several field functional areas across AZ US Oncology including but not limited to Medical Science Liaisons (MSLs), Scientific Project Medical Director (SPMD) team and precision medicine managers (PMM) for strategic planning and project execution. These external collaborations will be grounded in the aim to drive biomarker testing at select health systems across the United States.
Major Responsibilities
Accountable for the Heme medical Dx strategy and oversee creation and delivery of the Dx plan per indication within the heme indications. Develops the Dx plan of the Integrated Medical Affairs Plan for each assigned brand ensuring that specific annual objectives and milestones are set to enable the achievement of the longer term medical strategy.
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.
Deliver diagnostic education to internal and external stakeholders, including internal training.
Identify issues in current testing landscape and work with external stakeholders to develop solutions to remove or minimize diagnostic barriers to therapy use through collaborative partnerships.
Minimum Requirements
Advanced medical degree (MD, PhD).
3+ years of experience in health care delivery; including US experience and preferably hematology diagnostic or clinical lab experience.
Past pharmaceutical company experience working in a matrix environment is a requirement.
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.
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