Director, Global Integrated Evidence Planning (IEP) & Evidence Synthesis

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting.

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The Director of Integrated Evidence Planning (IEP), Evidence Synthesis is a unique, highly visible role that will be critical in driving Danaher’s overall evidence generation capabilities. This role will wear multiple hats including leading the company’s IEP process, driving the evidence synthesis needed to adequately derive evidence gaps and demonstrating subject matter expertise in real world evidence generation.

The IEP is a vital tool for evidence planning and execution, providing a dynamic plan for evidence generation teams to follow and ensuring comprehensive evidence packages for regulatory, launch, and post-launch strategies. The IEP Director will be responsible for creating, managing, and updating IEPs for assigned priority assets or programs, working closely with key partners across Medical Affairs, Clinical Affairs, Market Access, Global Product Management, HEOR and Regulatory Affairs.

Leveraging deep knowledge of the assay development lifecycle, the IEP Director guides cross-functional asset teams through the IEP process, facilitating discussions and strategic decisions at each lifecycle stage. They synthesize information from various sources (e.g., TPP, literature reviews) to develop credible IEP materials and discussions. After the initial IEP creation, the IEP Director tracks its progress to ensure planned tactics are executed and monitors new data for potential updates, conducting at least annual reviews. As the primary liaison with cross-functional teams, the IEP Director identifies process improvements and efficiencies, providing recommendations to the central IEP team to support continuous program enhancement.

To ensure that evidence gaps are being identified in a robust manner, this director will oversee the strategic execution of targeted and systematic literature reviews, utilizing AI-based tools to conduct comprehensive literature reviews and meta-analyses. This individual will play a crucial role in identifying and addressing evidence gaps to inform the company's integrated evidence planning process. Responsibilities include leveraging advanced AI technologies to synthesize data from diverse sources, collaborating with cross-functional teams to ensure evidence aligns with regulatory and market needs, and providing actionable insights to support the development and validation of diagnostic products.

Note that this role will have significant project management and administrative responsibilities to ensure appropriate sustainment of all IEP efforts and to drive the framework for streamlined evidence synthesis. 

This position is part of the Government Affairs and Market Access department and will be located in Sunnyvale, California. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Oversee the integrated evidence planning process, ensuring a comprehensive and consistent approach to evidence generation that aligns with the company's strategic goals and reflects robust cross-functional input/ownership.
• Conduct and supervise evidence synthesis, including targeted and systematic literature reviews and using advanced AI-based tools to inform the identification of evidence gaps; present findings and strategic recommendations to colleagues/senior leadership.
• Monitor the progress of approved, funded IEP plans by assigned functional owners from conceptualization to activation and ensuring the evidence underpinning IEPs remains up-to-date.
• Ensure program/project key milestones are met by partnering with vendors, identifying risks and capacity restrictions, communicating program changes to the cros