Sunnyvale, CA, 94086, USA
23 days ago
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. Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. 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 cross-functional teams. + Lead IEP process execution, creation, management, and maintenance including the preparation of reporting tools that document the ongoing progress of IEP plans (e.g., dashboards) and the creation of central repositories that link evidence to aligned assay IEP value messages. The essential requirements of the job include: + Bachelor’s degree with 12+ years of related work experience OR Master’s degree in field with 8+ years of related work experience in a health-related discipline such as epidemiology, biostatistics, health economics. + Extensive experience in evidence synthesis, including systematic literature reviews and meta-analyses, preferably within the diagnostics or pharmaceutical industry. + Experience in understanding real world evidence strategy and successfully translating findings into strategic insights and publications. + Proficiency in using AI-based tools for literature reviews and data synthesis. + Demonstrated ability to think strategically and drive evidence-based decision-making within an organization. Travel, Motor Vehicle Record & Physical/Environment Requirements: Domestic and international travel may be required up to 40% of your time. It would be a plus if you also possess previous experience in: + Direct experience conducting IEPs, either in consulting, diagnostics, medtech, biotech/pharma or facilitating similarly complex processes across a cross-functional set of stakeholders + Formal training or demonstrated experience in process improvements; excellent analytical, organizational, and project management skills. + Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and present complex information to diverse audiences. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com. The salary range OR the hourly range for this role is $165,400-$260,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. Operating Company: Cepheid
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