Senior Manager Clinical Science

- Plans and manages all aspects of the publication and presentation of clinical research data. Manage the multiple and complex interactions between global functional areas, external researchers and publication committees to ensure publications meet strategic objectives of the business. Responsible for developing strategies that meet the multiple goals of the clinical research organization, establishing publication committees, communicating publication plans, and executing to meet publication timing consistent with the strategic direction of the division. Represents clinical science at publication committees. Responsible for hiring, leadership and development of staff.
- Lead a team responsible for authoring clinical study protocols (and amendments), clinical study reports, and other regulatory documents, such as, investigator brochures, clinical evaluation reports (CER) for all CE mark products, no trial justifications, and answering questions from regulatory bodies.
- Requirements: 6-8 years of research experience with 4-6 years of research management preferred, or an equivalent combination of education and work experience. Supervision of clinical research publications processes is highly preferred. Management experience in other clinical operations positions desirable. Global experience preferred.
- Highly preferred experience and skills: IDE, excellent communication, ability to resent data clearly and succinctly to both scientific experts as well as a non-scientific audience, able to manage aggressive timelines, and willing to travel up to 20% of the time
- Must have authored clinical study protocols (and amendments), end-point and annual study reports, and other regulatory documents for regulatory submission, such as, investigator brochures, clinical evaluation reports, no trial justifications and must have answered questions from regulatory bodies.

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