Head of Medical Affairs for Molecular Diagnostics
Business Unit: Strategy & Innovation
Requisition Number: 233945
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Doctorate Degree
Travel Required: 10%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
(Products: Respiratory Infections, Gastroenteritis, Sexually Transmitted Infections, Childhood infections, Hepatitis, Tropical Fever, Immunosuppressed, Meningitis, etc.)
The Head of Medical Affairs, Molecular Diagnostics (MDX) will serve as a medical consultant to the business and develop, implement, guide and communicate the Medical Affairs strategy and activities for the MDX product focus/portfolio strategy. He or she will develop a cross-functional medical strategy aligned with Quality, Research and Development, Regulatory, Clinical Affairs, Manufacturing, Sales, Biostatistics, Marketing, and to position Siemens Healthcare Diagnostics as a trusted business partner and scientific leader in diagnostics.
· Serve as a consultant to Regulatory & Clinical Affairs in the design and execution of efficient and robust clinical trial and registration strategies. He or she will identify, advise and guide critical verification and validation activities to ensure the safety and effectiveness of products.
· Serve as a medical consultant to scientific marketing to ensure medical messaging is clear, validated and aligned with the organization’s strategic positioning of Siemens as the scientific leader in diagnostics.
· Engage strategic partners and key opinion leaders in product development and continued support through the product life cycle.
· Serve on the Product Health Team to provide medical input for product health issues and guide prioritization of resources, driving resolution of global product quality issues as warranted.
· Develop strategic relations with the medical and scientific leadership of key regional, national and global accounts to further develop and grow their business through partnerships, consultation and collaboration.
· Conceptualize and direct the testing or investigations pertaining to the development of the most complex new designs, products, methods, materials or processes and investigate possible application of results.
· Lead the analysis, evaluation and planning for the most complex methods of approach and organize means to achieve effective solutions to problems.
· Direct the evaluation of test data and results of the most complex investigations; conceptualize and direct the development of reports, charts, graphs, and other documents, and make appropriate recommendations.
· Lead the coordination of R&D support to arrange for the production of the most complex experimental runs or for the construction of experimental models and special test equipment.
· Contribute to the implementation and execution of In Vitro Diagnostic Medical Device Regulation (IVDR) activities through medical assessments of MDX products.
· Advise on medical risks and benefits to evaluate product safety and effectiveness in laboratory medicine in support of functional group activities for commercialized/marketed products as well as for product development activities.
· Maintains accurate documentation and files related to risk-benefit analyses and/or post-market surveillance activities. Contribute to post-market surveillance activities in alignment with policies and procedures and applicable standards/regulations.
· M.D., Ph.D. or M.D./Ph.D. in related areas with practical experience in clinical pathology preferred. Equivalent combination of relevant education and experience, such as Masters in medical technology, laboratory science, chemical, physical, or biological science AND a minimum of 3 years of medical laboratory experience in clinical consultancy and technical and regulatory oversight, as outlined above, may be substituted as appropriate. Board certification and ongoing accreditation by nationally and internationally known professional clinical and academic bodies such as ABCC, CACB, RCP, ABP preferred.
· Must have a proven track record in the ability to advance technologies, processes and practices in area of specialization, and serve as the leading point of authority and/or source of technical/scientific knowledge for area of expertise.
· An executive presence that engenders credibility coupled with outstanding communication, negotiation and interpersonal skills to build strong relationships enterprise-wide within a matrixed environment, as well as with external partners, customers, key opinion leaders, the FDA and other organizations at local, national and global levels.
· Demonstrated focus on customer expectations and product applications coupled with the ability to teach clinical implications both internally and externally.
· Proven ability to develop team members through mentoring and coaching in complex subjects.
· Collaborative, cross-functional consensus builder with a strong sense of self that enables one to be confident in his/her convictions, even if not commonly shared, with the ability to inspire enthusiasm and commitment from others.
· Superior critical thinking, clinical judgment and problem-solving skills coupled with extensive knowledge of the organization's business practices and issues faced.
· Demonstrates understanding of functionality/intended use of complex in vitro diagnostics and molecular diagnostics, and their application in clinical practice.
· Displays an expert level of critical thinking in applying principles of clinical laboratory medicine, including analytical laboratory practice (e.g. assay validation, quality control), regulations and clinical applications.
· Proactive attitude with logical, data driven approach to problem solving.
· Performs special assignments and provides technical and clinical advice in area of
Experience with CFR 820; ISO13485:2016 and IVDR EU 2017/746 is highly desirable