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 worlds 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, were working at the pace of change on diagnostic tools that address the worlds biggest health challenges, driven by knowing that behind every test there is a patient waiting.

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The Senior Director, Medical Affairs will lead the Medical Safety team, ensuring that Medical & Scientific Affairs are strategically positioned to provide timely medical and clinical consultation and review for pre- and post-market risk assessments, medical review, and adverse event reporting. This role is crucial in maintaining high standards of medical safety, compliance, and regulatory adherence at Cepheid. Additionally, the role involves significant cross-functional interactions, coordination with quality and regulatory teams, oversight of external safety boards as needed, and a focus on team training, development, and leadership.

This position is part of Medical and Scientific Affairs and will be located Remote, US. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Lead and manage the Medical Safety team, fostering a culture of excellence and continuous improvement, ensuring timely and accurate medical and clinical consultation and review for pre-/post-market risk assessments, medical review, and reporting of adverse events.

• Develop and maintain structures, processes, and procedures for effective medical risk assessments and all other medical safety activities.

• Manage cross-functional interactions to ensure integration of medical safety and compliance strategies with other departments (quality, regulatory, R&D, and others).

• Support pre/post-market activities including design specifications, regulatory submissions, and review of marketing and promotional materials.

• Provide medical/technical input to the strategic planning process for clinical innovation/new product development, provide internal and external medical education, support thought leadership activities and engage in other medical affairs functions as needed.

• Write and review product safety references to adequately assess Cepheid products for harm and safety risk.

The essential requirements of the job include:

• Physician (MD or equivalent) with 12 + years of experience

• 4+ years of experience managing people

• 5+ years of clinical experience

It would be a plus if you also possess previous experience in:

• Experience in clinical laboratory operations and/or in vitro diagnostics industries desirable.

• Board Certification (if US) preferred; Medical specialization in infectious diseases preferred

• Experience or training in adverse event reporting, risk assessments, and/or regulatory submissions desirable.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.

The salary range for this role is $200,000 - $250,000. 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. 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 Companys sole discretion, consistent with the law.

Join our winning team today. Together, well accelerate the real-life impact of tomorrows 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.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.