National Postdoctoral Association Career Center
The Medical Director / Pathologist will serve key roles in an emerging Medical Affairs function that provides leadership on medical, scientific and clinical decisions related to the overall Leica Biosystems business strategy. The Medical Director / Pathologist will support the Senior Medical Director in development and execution of the Medical Affairs functional strategy. Medical Affairs serves a critical customer-facing role as well as a variety of internal leadership and support roles, including pre- and post-market partnership to functions such as product management, sales and marketing, R&D, Clinical Affairs, Regulatory Affairs, Quality Assurance, Innovation, Pharmaceutical Partnerships, and Technical Support. The Medical Director / Pathologist is expected to provide pathology input to cross-functional and/or complex projects and tasks on global and/or local level. In addition, the Medical Director / Pathologist will engage internal and external stakeholders on a wide variety of clinical, medical and scientific discussions.Major Responsibilities
- Pathology slide interpretation supporting new product development, assay validation, and case review.
- Collaboration with product management, sales, marketing, and field support teams in peer-to-peer interactions by providing scientific and medical perspectives, in compliance with applicable regulations and standards.
- Medical expertise input to device risk analyses, health hazard evaluations (HHE), adverse event review, risk/benefit reporting, and health authority interactions (e.g. FDA)
- Partner cross-functionally to collect, evaluate and communicate key clinical, medical and scientific data to support R&D projects, regulatory strategy, compliance-related tasks, and commercial projects across all business areas and across the product lifecycle
- Support pharma partnerships (companion diagnostics), clinical evidence generation partnerships, and strategic growth efforts through collaboration with internal teams and cultivation of relationships in the pathology practice and biopharmaceutical industry communities.
- Provide strategic and tactical direction to support timely development and execution of R&D as well as commercial programs
- Provide insight into new product development and innovation opportunities, actively participating in prioritization of opportunities based on clinical value.
- Use the Danaher Business System (DBS) and standard work to systematically measure/report/improve the overall clinical affairs process.
- Influence others across LBS and Danaher while maintaining strong, collaborative relationships.
- Additional responsibilities as assigned.
- MD with anatomic pathology specialty board certification in appropriate country (active medical license not required).
- Understanding of anatomic pathology research, practice, and market landscape.
- Experience with digital pathology systems and emerging tools.
- Familiarity with clinical pathology, biomarker technologies, and vision of future trends in pathology research and practice, including molecular pathology.
- Team player with professional presence and demeanor coupled with superb written and verbal communication skills.
- Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
- Excellent problem-solving, conflict-resolution and decision-making skills
- Fluency in written and spoken English
- MS or PhD in a scientific discipline with advanced scientific training and experience, with track record of quality publications.
- Experience in pathology and clinical informatics, machine learning, and artificial intelligence as applied to digital pathology research and practice.
- Board Certification in clinical pathology or pathology subspecialty such as molecular pathology, surgical pathology, or other organ-specific anatomic pathology specialty.
- >2 years of pathology practice or industry pathology experience following completion of pathology training
- Independent research experience, with track record of authored publications and presentations
- Experience with risk management / safety assessment in medical device or biopharmaceutical industry
- Prior interactions with regulatory agencies on pre- and postmarket issues
- Development and/or advocacy for in vitro diagnostic devices
- Experience managing external customer relationships including external advisory boards and noted experts
- Critical thinker able to drive effective decision making in a global environment to resolve complex regional or functional problems, regardless of popularity of decision
- Ability to act as a change agent through interpersonal interactions; professional maturity and confidence in expressing a point of view with senior management and external stakeholders; ability to give engaging and persuasive presentations to diverse audiences.
- Creative problem solver with the ability to spot issues of importance early and partner with colleagues toward a solution.
- Ability to build and maintain productive relationships with leaders of other functional areas within and across the business to influence decisions, align on objectives, and drive progress toward achievement of business objectives.
- As part of multidisciplinary teams, generate a vision, establish direction, motivate colleagues and employees, encourage diverse viewpoints, exhibit inclusive behaviors, and encourage associate improvement and development.
- ~30% travel, including international.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here .
- Job ID: 54303255
- Position Title: Medical Director / Pathologist
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Posting ID: 564763350Posted: 2020-08-05