Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
Partners with Clinical Development and other functions to develop operationally feasible and clear protocol concepts and final protocols. Leverage phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level strategy. Independently oversees one or more clinical studies by establishing the operational strategy and securing excellence in execution through the CRO partner.
**Partners with Medical Research and other functions to:**
* Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans
* Leverage appropriate on going data review to identify and mitigate patient safety, study design, data integrity or study conduct issues
* Ensure all operational aspects support end point integrity and data validity.
* Able to influence MD on clinical study/program direction based on changing internal and external landscapes within phase, disease or therapeutic area; able to think strategically to best position a study within the current Clinical Development Plan
**Secures operational excellence and delivery for one or more clinical studies by:**
* Developing operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country Lead
* May also be responsible for contributing to a clinical development plan within a program moving into a new or subdivision of a current indication.
* Builds a rich knowledge of specific Area(s) of Expertise within a phase.
* Utilizes operational expertise and scientific assessment to evaluate study feasibility: assess end point measurement options, and ensure the successful execution of study(ies).
* Approximately 8 years of clinical research / project management experience preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline, and budget expectations.
* Prior investigator site and/or monitoring experience is advantageous
* Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development.
* Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas.
* Ability to establish operational plans and support the CRO in the execution of the plans.
* Requires a balance of scientific and operational/project management and team leadership expertise.
* Must be able to build effective relationships across and up and down the organization.
* B.A. or B.Sc. in a scientific discipline; advanced degree preferred.
* Scientifically and clinically astute with very strong project management skills.
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