Danaher Corporation Senior Director, Clinical Affairs in Minneapolis, Minnesota
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Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Senior Director, Clinical Affairs for Beckman Coulter Diagnostics oversees comprehensive strategic and operational leadership of the Clinical Affairs team and delivering on a large portfolio of multi-product projects across more than one therapeutic area and assay type. This individual will be an expert in clinical trial execution, budgeting, contracting, strategic evidence planning, and contractor/vendor management, building trusted and reliable relationships with the laboratorians, clinicians, and customers we serve.
The Sr Director is a high-profile member of the senior leadership team, accountable for aligning successful clinical strategies with business and commercial goals.
The Senior Director of Clinical Affairs global leadership responsibilities include clinical evidence generation strategic planning or DHR on cross-opco initiatives. This includes leading Kaizens and related DBS events, and ability to develop life-cycle Product Evidence Strategy Plans that may be funded either internally or through the management of grants with external partners.
This position is part of the Global Clinical Affairs Department of Beckman Coulter’s Quality, Regulatory & Clinical Organization. This Senior Director supports the Chemistry and Immunoassay business and will be located Minneapolis/St Paul region Minnesota (relocation available). The role will report to the Global Vice President of Clinical Affairs.
It will require expertise in change management and experience with growing a clinical affairs team, aligning to the global clinical structure to meet new regulatory standards requiring both pre-market and post-market IVD clinical trials designed to drive market adoption of our products. This position reinforces and aligns to business needs and expectations for clinical evidence planning that considers customers’ needs around the globe (change from a US/EU-centric mindset to global strategy).
In this role, you will have the opportunity to:
Lead and build comprehensive clinical trial strategies across multiple product and assay types for multi-level team of clinical scientists
Serve as primary clinical point of contact with the US FDA and other foreign regulators and notified bodies, and act as Clinical Lead for complex FDA negotiations leading to successful new product clearance
Participate in the development of new technologies that can lead to securing patents in which they will be named
Regularly interact with senior level business, regulatory and cross op-co leadership teams to build strategic plans for new product development, stakeholder management, and technology dissemination
Develop and execute on a successful publication strategy
Work cross Op-Cos as a member of the Senior Clinical Affairs leadership team to build agility, efficiency, and followership globally
Partner with more junior and rising leaders to build resilient, resourceful, and strong succession ladders and to ensure the growth and development of those you manage
Partner with leaders in new and rising businesses to develop and integrate new technologies such as Real-World Evidence, ensuring that current DHR businesses benefit from the new capabilities and opportunities these enable
The essential requirements of the job include:
Bachelor’s degree with 20+ years of applicable experience or Master’s/Doctoral degree with 18+ years of experience
6+ years of experience managing and developing people as well as managing complex clinical affairs budgets and site negotiations
Clinical chemistry, immunoassay or Class III medical device experience
Broad knowledge of medical device industry, regulatory requirements, and frameworks
Demonstrated success in managing highly complex multi-product, multi-technology portfolios of projects, globally highly preferred
Comprehensive knowledge of FDA & EU IVD regulations experience including a conversant knowledge of evolving China regulatory expectations
Nimble presentation skills for both planned and ad hoc presentations
Ability to travel approximately 25% as business needs dictate
It would be a plus if the candidate also possesses or has previous experience in:
Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs
Extensive experience of successful application of diagnostic technologies (IVD) is highly preferred, as well as strategy development and developing clinical sections for US regulatory submissions
Mandarin Chinese proficiency
#LI-MR1 At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
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 firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.