Senior Director MDx Medical & Scientific Affairs 9/3/2016
JOB DESCRIPTIONAPPLY Functional Area: Management
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 Chief Medical Officer (CMO); Assure that these activities are aligned with QIAGEN corporate goals to provide the best sample preparation, assay, and instrument solutions to fulfill unmet medical and clinical testing needs that improve health care.
The Senior Director s scope of activities will span across the entire portfolio to include all MDx sample preparation, assay, instrument, and bioinformatics products and workflow/service solutions in the area of oncology
For this position, the primary emphasis will be directed to Medical and Scientific Affairs activities for products that are 6 months from launch, and will continue to support product launch and evidence-based support for products on the market.
Some of the responsibilities are as follows:
- 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 clinical value index 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 QIAGEN s 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 and scientific landscape. Encourage development of disease awareness presentations and implement medical education initiatives
- Review of product inserts, commercial literature and corporate documents to validate compliance with guidelines.
- Ph.D. or MD degree in a related field with extensive experience and demonstrated accomplishments in basic and translational research.
- 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 wealth of with significant accomplishments both Translational Research and 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 immunodiagnostics and molecular
- Demonstrated leadership in program management, team building, and guidance internally, and evidence of forging collaborations and influencing without authority with key thought leaders
- Consummate lecture and oral presentation skills. Emotional intelligence in the arena of sales/marketing and knowledge of the workflows, duties and responsibilities of the clinical lab professional.
- Ability to communicate concepts, strategies and recommendations both orally and written with a high degree of clarity and accuracy.
- Have the ability to effectively communicate vision and goals within department, to executive management to employees at all levels within the company some of whom have various levels of clinical and medical knowledge.
- Experience facilitating and leading meetings that result in an environment that fosters imaginative, focal, and technical discussions leading to optimal decisions. - Experience coaching and developing employees at all levels within the organization
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.