Vice President, Clinical Affairs, Leica Biosystems and Mammotome|
Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps. Our mission of Advancing Cancer Diagnostics, Improving Lives is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers.
Mammotome associates know that every moment matters when it comes to advancing breast cancer diagnostics and surgical solutions. When you come to work at Mammotome, youre collaborating with a global team of engineers, designers, communicators, strategists, and specialists to improve patient outcomes. If you want to be inspired to grow every day, join our diverse, hardworking, high-performing team.
Major Responsibilities (other duties may be assigned):
- Accountable for the performance and results of the companys global Clinical Affairs, Biostatistics, Medical Writing, Clinical Compliance, and Data Management functions
- Applies in-depth industry and commercial knowledge and experience to develop and execute clinical affairs strategies to achieve key business objectives in an evolving competitive environment, differentiating LBS products with evidence data and content
- Establishes collaborative relationships with senior leaders across LBS and other OpCos, influencing the clinical affairs operational strategy across OpCos
- Establishes collaborative relationships and shapes the opinion of pharmaceutical partners, regulators and healthcare providers, towards favorable LBS outcomes
- Cultivates a positive work environment that reflects company values, embodies collaboration across functions and OpCos, and promotes associate development
- Maintains current knowledge of innovative clinical evidence strategies, using that knowledge and critical thinking to evaluate and resolve key complex business challenges across a highly diverse product portfolio.
- Develops strategies that provide new differentiated evidence solutions and enable new peer-to-peer customer interactions, resulting in uptake through clinical and technical communication with Pathologists and Oncologists
- Drives talent management and engagement of the team using Danaher business tools
Education and Experience:
Bachelor of Science (B.S.) or Master of Science (M.S.) or Doctor of Philosophy (Ph.D.). in Histology, Microbiology, Biomedical Engineering or a related field and a minimum of the following years of industry or relevant experience according to degree:
- Bachelors Degree 15+ years
- OR Masters degree with 10+ years
- OR Doctoral degree with 8+ years
In addition, at least 7 years of supervisory experience is required.
Medical Technology MT(ASCP) or equivalent, or certification as a clinical research associate (CCRA), regulatory affairs professional (RAC) or clinical research coordinator (CCRC) is desirable.
This position requires directly related experience in Clinical Program planning and execution, including an understanding of clinical strategy, the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, the scientific, statistical, regulatory and compliance requirements of clinical research, compliant medical communications, and the development and launch of medical products of diverse regulatory classification. Demonstrated career success in achieving commercial release of products related to pathology imaging, advanced staining, core histology, tissue acquisition, companion diagnostics or pharmaceutical development is highly desirable. In addition, this position requires proven success at a senior leadership level, working in a matrixed business structure.
Travel: Up to 50%
When you join us, youll also be joining Danahers global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, youll 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.
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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 email@example.com to request accommodation.
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