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Sr Director, Medical Scientific Affairs

Company: Leica Biosystems
Location: Vista
Posted on: November 21, 2020

Job Description:

The Clinical & Medical Affairs function provides leadership and direction on medical, scientific and clinical decisions related to the overall Leica Biosystems business strategy. The scope of the Sr Director, Medical & Scientific Affairs role involves being an active member of the Clinical & Medical Affairs leadership team. The role will support the VP, Clinical & Medical Affairs with complex issues and projects, as well as the development and execution of the Clinical & Medical Affairs functional strategy. This role will also establish, lead, and maintain external academic, biopharma and clinical expert/customer relationships globally. Directs Scientific and Medical affairs activities for Leica Biosystems. Major Responsibilities * Build and lead team of Medical Directors and field Medical Scientific Liaisons who support uptake through clinical and technical education with Molecular Pathologists and Oncologists * Lead development of clinical education content to support the commercial team and enable broad understanding of the clinical utility of LBS products * Respond to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and LBS policies & procedures * Serve as key external medical voice for LBS with partners, customers, KOLs, and in industry forums, representing our brand, products, and technology with the utmost credibility * Talent Management: Identify appropriate skills to achieve objectives, develop associates, implement and report key medically related performance indicators, ensure appropriate budget and resource management * Support clinical-marketing planning, including conference planning and support, medical education content development, faculty speaker training, sales training, reimbursement initiatives, and review of promotional and educational materials. * Participate in the development and execution of a key opinion leader (KOL) outreach plan, including supporting meetings with KOL s. * Work with Medical Directors to take complex medical messages and position them to enable clear and concise understanding by both external audiences and partners within LBS. * Listen for and interpret new clinical data from conferences and literature, as well as competitive intelligence, and report back on findings to management, medical affairs and marketing stakeholders. Required Skills/Experience * Practical knowledge and experience working with global regulatory bodies & notified bodies, including but not limited to the FDA, CFDA, Irish Medical Board, MHRA, BSi, etc. Experience/prior oversight for risk assessment, patient safety & quality assurance processes * Strong ability to make balanced business decisions; strong communication skills to effectively connect with the scientific audience as well as the ability to explain complex medical issues simply to a lay person; excellent interpersonal, organizational, and influencing skills; ability to work in a matrix environment and a motivational approach to managing others * Medical degree with 8+ years experience; experience includes 5+ years managing people * Substantial experience and knowledge of in vitro diagnostics (IVDs) * Strong relationships (or ability to build them) with Key Opinion Leaders within the molecular pathology and oncology sector and pharmaceutical industry * Demonstrated understanding of the payer landscape and reimbursement mechanisms * Ability to make data driven decisions that maximize business success and patient impact * Demonstrated expertise in interpretation, summarization and presentation of scientific data required * Demonstrated expertise in technical writing (e.g. published manuscripts in peer reviewed journals, investigator brochures, or the clinical sections of PMAs and 510K submissions) required * Diagnostic industry experience specific to risk assessment & patient safety process preferred Travel: Periodic travel may be required (up to 25%). What we have to offer: Check out our benefits at 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.

Keywords: Leica Biosystems, Vista , Sr Director, Medical Scientific Affairs, Healthcare , Vista, California

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