Sr. Director, Medical & Scientific Affairs, Global MDx (3420)

Organization
QIAGEN
Job Location
19300 Germantown Road
Germantown, MD 20874
Job Description

Position Description

- Responsible for the development of medical strategies to provide relevant data evidence from company and clinical studies to ensure the strategy is clearly defined and consistent with the clinical development and strategic objectives for each product, and that appropriate processes are in place for review, approval, management and support of studies.

- Responsible for leading and managing key thought leader engagement and knowledge development initiatives and programs. In addition, the position will require contributing strategic guidance to product, marketing and sales teams to ensure alignment of medical affairs with clinical development and commercial strategies/tactics
 
- Responsible for providing leadership and management in identifying needs for clinical trials and registries and lead the execution.

- Responsible for representing QIAGEN at conferences, medical meetings, advisory boards, outreach meeting and key thought leader engagement.

- Responsible for fostering an ethical and compliant environment in accordance with company policies and procedures and industry regulations and standards.

- Responsible for remaining current on market and industry trends, FDA regulations, competitor products, and leading medical affairs strategies to ensure the organization remains competitive and meets and exceeds its commercial objectives.

- Responsible for aligning with Procurement, Legal, and Quality Assurance professionals within the company as well as with pharmaceutical, biotechnology, and device clients, as well as third party vendors to ensure that all contractual obligations are met.

- Develop Scientific Advisory Boards and Speaker Bureaus that are appropriate and address the clinical and scientific needs of products that are in line with development, early adoption, and lifecycle management of particular products.

- Provide medical insights and actionable scientific guidance to galvanize translational research, demonstrates proof-of-concept, and promotes clinical studies resulting in fully integrated diagnostic tests, which include diagnostic assays, equipment and software.

Requirements

M.D. or M.D./Ph.D. degree or equivalent required
At least 10 years of experience in planning and managing clinical trials for new assays or compounds, preferably in the areas of infectious disease, cancer diagnostics, and next generation sequencing applications. Experience working in a pharmaceutical company and active experience in all aspects of IVD clinical trials is a must.
A proven track record of effective project and people management. Strong program management and skills. A hands-on approach to overseeing clinical trials coupled with a willingness and ability to travel to pharmaceutical company planning sessions and clinical trial sites alike.
Sound knowledge and expertise in international regulatory requirements and clinical product development. In-depth knowledge of cross-functional areas associated with clinical development and operational execution of studies, including biostatistics, data management, and safety reporting.
Proven ability to work well and effectively in a team environment. Demonstrated experience at building and maintaining strong long-term professional working relationships and in managing collaborations with outside partners, third party research organizations, and government regulatory agencies.
A diplomatic personality that can effectively represent QIAGEN to diverse international regulators and partners.
Strong written and oral communication and presentation skills, including ability to present well in multi-cultural settings.

Personal Requirements

 

M.D. or M.D./Ph.D. degree or equivalent required
At least 10 years of experience in planning and managing clinical trials for new assays or compounds, preferably in the areas of infectious disease, cancer diagnostics, and next generation sequencing applications. Experience working in a pharmaceutical company and active experience in all aspects of IVD clinical trials is a must.
A proven track record of effective project and people management. Strong program management and skills. A hands-on approach to overseeing clinical trials coupled with a willingness and ability to travel to pharmaceutical company planning sessions and clinical trial sites alike.
Sound knowledge and expertise in international regulatory requirements and clinical product development. In-depth knowledge of cross-functional areas associated with clinical development and operational execution of studies, including biostatistics, data management, and safety reporting.
Proven ability to work well and effectively in a team environment. Demonstrated experience at building and maintaining strong long-term professional working relationships and in managing collaborations with outside partners, third party research organizations, and government regulatory agencies.
A diplomatic personality that can effectively represent QIAGEN to diverse international regulators and partners.
Strong written and oral communication and presentation skills, including ability to present well in multi-cultural settings.

How to Apply

If interested, please apply online at www.qiagen.com/careers .  Requisition # 3420

About Our Organization

As the innovative market and technology leader, QIAGEN creates sample and assay technologies that enable access to content from any biological sample.

Our mission is to enable our customers to achieve outstanding success and breakthroughs in life sciences, applied testing, pharma, and molecular diagnostics. We thereby make improvements in life possible.

Our commitment to the markets, customers, and patients we serve drives our innovation and leadership in all areas where our sample and assay technologies are required.

The exceptional talent, skill, and passion of our employees are key to QIAGEN’s excellence, success and value.

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