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Vice President, Clinical Affairs

Company: myGwork
Location: Brea
Posted on: September 19, 2022

Job Description:

Wondering what's within Beckman Coulter? Take a closer look. At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. Beckman Coulter 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 VP Clinical Affairs for Beckman Coulter is responsible for leading a multi-specialty Global Clinical Affairs team, leveraging the Danaher Business System (DBS) and tools to drive timely and high-quality execution of clinical evidence strategies for in-vitro diagnostic and life science clinical programs sponsored in multiple regions for Beckman Coulter. The role encompasses Clinical Affairs, Biostatistics and Data Management, oversight for the Investigator Sponsored Research Program, Clinical Compliance, and Medical/Technical Writing and publication for compliance and related activities. They will participate in external standard-setting and regulatory agency interactions as well. This position will be United States based with a preference for Brea, CA, Chaska, MN, or Miami, FL but could be remote with increased travel as needed; work hours will be aligned with the US. The VP of Clinical Affairs will work to translate global market needs and regulatory requirements into successful clinical evidence strategy planning, clinical trial strategy, trial design, and execution to ensure market access and product lifecycle sustainment. They will be accountable for engaging with regulatory bodies and industry associations to shape global standards and regulations related to clinical research and development and must collaborate across multiple Danaher operating companies to proactively create clinical program standard work and synergies that measurably accelerate business goals and drive best practice. In this role, you will have the opportunity to: Translate global business strategies into a detailed operating plan for the clinical affairs function across multiple product lines (e.g., flow cytometry, hematology, urinalysis, chemistry, immunoassay, microbiology), across the Life Sciences & Diagnostics segments and across multiple regions (U.S., Europe, China). Proactively follows key trends that affect each business and leads the local clinical organizations in executing clinical evidence strategies that are designed to drive regulatory clearance, market awareness, and market adoption of Beckman Coulter products across the globe. Actively participate in industry consortia that shape and influence the global standards that govern clinical research. Anticipates key changes and adapts company policies and standard operating procedures (SOPs) with a measurable process to build knowledge and ensure compliance with all applicable company policies, procedures, and regulatory standards. Provide leadership using the Danaher Business System and tools to cultivate new DBS leaders and iteratively benchmark clinical function processes against industry best practice. Oversee the process for the timely and high-quality preparation of assigned clinical deliverables including internal progress reports (metrics, bowlers, action plans), external reports to support regulatory submissions to the global regulatory agencies, and clinical evidence intended for external audiences (e.g. abstracts, presentations, whitepapers, publications). Oversee the processes where the clinical function is actively engaged in the strategic planning, execution, and assessment of clinical function deliverables throughout a product's lifecycle to ensure that products are performing as intended across all regions where the product is registered. Responsible for talent management and development of the function including workforce planning to ensure knowledge transfer through systems/processes to retain know-how, building such into programs for development planning of functional capability and onboarding of new personnel. Selects and actively develops managers who value leading with DBS. The essential requirements of the job include: Bachelor's degree with 20 years of experience in Biological Sciences, Life Sciences or Masters/Doctoral degree with 18 years of experience in same area 20 years within Clinical Research and/or New Medical Product Development D irect experience in Clinical Affairs Program Planning and execution of both pre-market and post-market trials across multiple geographic regions, including understanding of clinical strategy, clinical laboratory, assay/instruments, in vitro diagnostic product design and usage, and the scientific, statistical, regulatory and compliance requirements of clinical research 6 years proven track record leading global teams and successfully managing complex organizations 5 years demonstrated experience in Quality Assurance, Auditing, Biostatistics, Data Management 5 years proven track record with Invitro Diagnostic/Medical Device development Able to travel domestic and international up to 30-50% as business needs are identified The successful candidate will: Demonstrate ability to achieve goals through interaction with individuals not under their direct control Have some proficiency in Mandarin Chinese Participate in professional activities outside of normal business hours It would be a plus if you also possess previous experience in: Advanced degree PhD, EdD, PharmD or MD) Experience with pharmaceutical or high-risk medical device clinical research Medical Technology MT(ASCP) or equivalent Certification as a clini cal research associate (CCRA/CCRP), regulatory affairs professional (RAC), quality or compliance professional (CQA) or clinical research coordinator (CCRC) At Beckman Coulter Diagnostics 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 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 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 . 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 applyassistancedanaher.com to request accommodation. If you've ever wondered what's within you, there's no better time to find out. This employer is a corporate member of myGwork - LGBTQ professionals, the business community for LGBTQ professionals, students, inclusive employers & anyone who believes in workplace equality.

Keywords: myGwork, Fullerton , Vice President, Clinical Affairs, Executive , Brea, California

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