Danaher Corporation Clinical Evidence Lead – Mammotome Global Strategy in Cincinnati, Ohio
Nearly every one of us has been impacted by cancer in some way. When you join Leica Biosystems and Mammotome, you’re helping make a difference in advancing cancer diagnostics. Join our global team as a Clinical Evidence Lead and help us transform the industry! This position can be a remote role with occasional travel to the office.
At Mammotome, our passion drives innovative technologies for patients along the breast cancer care pathway. We strive to improve the patient's journey and achieve better outcomes through our ever-expanding portfolio of Mammotome breast biopsy products and Neoprobe and Sentimag lesion localization systems. For more information, visit mammotome.com and follow Mammotome on social media (Facebook (https://www.facebook.com/Mammotome-104205904314266/) , LinkedIn (https://www.linkedin.com/company/mammotome) , Twitter (https://twitter.com/Mammotome) , Instagram, YouTube).
Mammotome offers an exciting and rewarding opportunity to begin or continue your Danaher career. As a global medical device company with a portfolio focused on the breast cancer care pathway, serving Radiologists and Breast Surgeons, we strive to improve the patient's journey and achieve better outcomes. Acquired by Danaher in December 2014, Mammotome enjoys a unique and relatively flat organization, enabling frequent touchpoints with senior leadership at all levels of the organization.
Leica Biosystems (LBS) 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 Leica Biosystems Clinical & Medical Affairs function provides support to Mammotome on the development of evidence plans and leadership/oversight for medical, scientific, and clinical decisions.
The Clinical Evidence Lead, Global Strategy role is an active member of the Clinical & Medical Affairs leadership team and works closely with Mammotome's Marketing leadership team to develop and execute comprehensive evidence plans to support global growth initiatives. The role requires leading global evidence initiatives to support new product development, pre and post-market studies, and internal evidence development processes across multiple functions.
Responsibilities we will trust you with:
Evidence strategy – synthesis of Voice of Customer requirements into recommended evidence investments. Comprehensive evidence plan for all priority products and markets to meet customer needs and drive market awareness/adoption.
Study design – protocol writing, enrollment strategy, collaboration on statistical analysis plan/data management plan, monitoring plan writing
Study conduct – management of external vendors & contract research organizations (CROs), quality and integrity of clinical data (data management), clinical study monitoring
Study reporting – data analysis & presentation to internal and external stakeholders, contribution to clinical reports and peer-reviewed publications
Providing direction and task oversight to others on the clinical team for one or more programs
Leads the investigator initiates study and medical/clinical information request processes
Provides oversight and approval for select marketing claims and materials
The role involves collaborations with internal project stakeholders (Product Development, Clinical Affairs, R&D, Quality, Regulatory, Health Economics and Reimbursement, Medical Affairs, etc.) and external partners (such as co-development collaborators and CROs).
Your areas of knowledge and expertise that matter most for this role:
Bachelor of Science (B.S.) or Master of Science (M.S.) or Doctor of Philosophy (Ph.D.). and a minimum of the following years of industry or relevant experience according to degree:
Bachelor's Degree with 10+ years; Or,
Master's degree with 7+ years; Or,
Doctoral degree with 5+ years.
Demonstrated experience in creating global evidence plans to support new product development, developing clinical strategy, study design/execution, and study monitoring for medical devices in a regulated environment.
Demonstrated experience in effectively negotiating with regulators (such as the U.S. Food and Drug Administration) and designing/executing clinical programs resulting in a successful global commercial release.
Experience in medical devices, interventional oncology, interventional radiology is highly preferred.
Demonstrated strong ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.
Demonstrated strong ability to handle and resolve conflicts and work under stressful conditions and in an environment of changing priorities.
Demonstrated ability or track record of successful results, building effective teams, and getting work done through others.
Travel: Up to 40% (in non-COVID times)
What we have to offer:
Check out our benefits here: https://danaherbenefitsinfo.com/
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate 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.
This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.
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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .