Senior Director, Medical Affairs

Danaher Corporation

1d•$200,000 - $250,000•Remote

About The Position

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 which makes everything possible. 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.

Requirements

Physician (MD or equivalent) with 12 + years of experience
4+ years of experience managing people
5+ years of clinical experience

Nice To Haves

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.

Responsibilities

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.

Benefits

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.
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.

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