A fantastic opportunity has arisen within the MDx business area for the position of a Senior Director, Medical and Scientific Affairs. The successful candidate will identify focal areas of Medical and Scientific Affairs activities and implement programs in close collaboration with the Head of the Oncology and Precision Diagnostic Business; Assure that these activities are aligned with QIAGEN corporate goals to provide the best oncology solutions to fulfill unmet medical and clinical testing needs that improve health care.
- Maximize QIAGEN MDx assay medical value with a focus on the impact of diagnoses and medical decisions; develop internal and external program to codify and implement âclinical value indexâ as a core value to provide to clinical research, as well as to reimbursement and public policy affairs.
- Develop applicable patient groups to demonstrate assay utility, and reveal novelty, and unmet needs.
- Determine how changes in medical practices impact product scope, utility, and placement of QIAGENâs assay pipeline.
- Implement key medical and scientific core messages to support commercial activities at tradeshows, medical and scientific congresses, and in customer-facing field activities.
- Provide due diligence and evaluate key scientific publications and technology that influences efficacy of molecular diagnostic assays and instrumentation.
- Assist in selection of stakeholders and patient groups for new prospective trials or observational cohorts.
- Review analytic and clinical performance data for new products to be submitted for regulatory approval.
- Scientific communication and intelligence at congresses, satellite symposia or conferences.
- Generate presentation materials, publications, and guidance documents that communicate medical relevance of products.
- Develop global KOLs, regional influencers and Advisory Boards.
- Competitive intelligence (communication with experts, review of literature, etc.).
- Assessment of medical need and scientific dossier to provide input in product design.
- Scientific PR; Organization the activities and deployment of Medical Science Liaisons to provide scope of activities product scope.
Position Requirements
- D. or MD degree in a related field with extensive experience and demonstrated accomplishments in the field of oncology.
- Work with global pharmaceutical companies on companion diagnostics is a plus.
- Demonstrated knowledge of the process of clinical lab verification and validation procedures for new assays.
- Outstanding record of peer-review publication and demonstrated efficacy in medical and scientific affairs activities as they pertain to molecular diagnostic assays and instrumentation.
- A significant accomplishments of Medical Affairs activities in academia and/or industry.
- Extensive experience in creating and managing teams and integrating diverse inputs from Clinical/Regulatory affairs, Scientific Affairs, Research & Development, and Sales/Marketing a plus.
- Successfully directed and led Medical Affairs activities, disease awareness, and medical product training programs within a preeminent diagnostics company which resulted in the commercialization of clinical diagnostic test kits and instrument/reagent systems and adoption of tests in the setting of a results-reporting clinical diagnostics laboratory.
– Strong technical background in the diagnostics industry – preferably immunodiagnostics and molecular diagnostics or related fields.
- Must have authored and/or co-authored multiple articles and platform presentations that focus on clinical advances in the diagnostic industry and/or molecular diagnostics.
- Demonstrated leadership in program management, team building, and guidance internally, and evidence of forging collaborations and influencing without authority with key thought leaders.
Personal Requirements
- Strong communication skills and working in a cross functional team setting.
- Willing to travel 25%.
What we offer
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.
QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.