Sr Manager, Clinical Operations Lead - United States
|External Posting Title||Sr Manager, Clinical Operations Lead|
|Job Description||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.
1. 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
2. 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).
|Location||Cambridge, MA, US|
|Job Category||Clinical Operations|
|Qualifications||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.
|Education||B.A. or B.Sc. in a scientific discipline; advanced degree preferred. Scientifically and clinically astute with very strong project management skills.|
|About Biogen||Corporate Overview|
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer?s disease, Parkinson?s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek?s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science?s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
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