Sr. Manager, Clinical Science

Sr. Manager Clinical Science (Global - Remote). This leadership role is responsible for the oversight of all clinical trial strategies globally for Danaher Diagnostics. This role will specifically support Leica Biosystems an operating company of Danaher Diagnostics. You will lead a team of clinical scientists driving strategic study designs ensuring regulatory compliance and achieving key milestones for critical clinical studies in these vital markets.

This position is part of the Danaher Diagnostics Leica Biosystems organization and will be a remote role. At Danaher Diagnostics our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role you will have the opportunity to:

• Oversee the scientific planning and design of clinical studies for Digital Pathology and Immunohistochemistry (IHC) & In Situ Hybridization (ISH) Companion Diagnostics (CDx) and Medical Device ensuring scientific validity and alignment with overall clinical strategy.

• Ensure the scientific rigor and accuracy of clinical protocols case report forms study reports and other clinical documentation

• Serve as a key scientific liaison working cross-functionally with R&D Regulatory Medical Affairs and other teams to integrate clinical insights into product development and commercialization strategies.

• Collaborate closely with Regulatory Affairs to support regulatory submissions and interactions with regulatory agencies by providing scientific expertise and clinical study data interpretation

• Build lead and mentor a high-performing team of clinical scientists providing mentorship guidance and fostering their professional development to ensure high performance and scientific excellence

• Establish and maintain strong collaborative relationships with internal cross-functional teams (e.g. R&D Regulatory Affairs Medical Affairs Quality Assurance Data Management Clinical Operations Commercial) and external partners (e.g. CROs investigators key opinion leaders) to ensure successful clinical program execution.

• Manage the analysis and interpretation of clinical study data contribute to the preparation of regulatory submissions and guide the dissemination of research findings through publications presentations and internal reports.

The essential requirements of the job include:

• Bachelors degree in Life Sciences Healthcare or a related field with 12 years experience in clinical research specifically with significant experience in US and/or EU trials or a Masters or Doctoral degree with 10 years of same experience.

• 4 years direct leadership experience including experience managing clinical research scientists

• In-depth understanding of clinical study design and methodology in the diagnostics medical device or pharmaceutical industry with products intended for the US and EU markets.

• Demonstrated ability to identify and solve complex issues in clinical trial conduct and scientific interpretation

• Ability to critically review and interpret scientific and clinical trial data and oversee the scientific aspects of study protocols and reports

• Excellent leadership communication (written and verbal) and interpersonal skills for managing a team and collaborating with cross-functional stakeholders

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

• Experience in study designs for in vitro diagnostic technologies (IVD) is highly preferred specifically for Digital Pathology and Immunohistochemistry (IHC) & In Situ Hybridization (ISH).

• Advanced degree in Science Healthcare or Regulatory/Clinical Affairs

• Professional certification in Clinical Research (e.g. SoCRA ACRP).

Leica Biosystems 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 Danaher Benefits Info.

At Leica Biosystems 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 Leica Biosystems can provide.

The annual salary range for this role is $170000 to $190000. 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 Companys sole discretion unless and

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

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.

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