Summary:

Through Biogen’s Ophthalmology franchise, our mission is to maintain and restore sight in patients with inherited retinal diseases. We are clinical-staged focused on developing and commercializing a pipeline of novel and potentially curative, one-time retinal gene therapies for patients suffering from rare inherited retinal diseases that would otherwise progress to blindness, and, for which, there are no currently approved treatments.

Job Description:

Through Biogen’s Ophthalmology franchise, our mission is to maintain and restore sight in patients with inherited retinal diseases. We are clinical-staged focused on developing and commercializing a pipeline of novel and potentially curative, one-time retinal gene therapies for patients suffering from rare inherited retinal diseases that would otherwise progress to blindness, and, for which, there are no currently approved treatments.

We are seeking an Associate Manager, Clinical Operations Lead for the Company’s Waltham, MA and/or Cambridge, MA, USA office(s). This is an excellent opportunity for someone with strong organizational skills and the ability to work on a variety of tasks and projects simultaneously with minimal supervision. In addition, the successful candidate must have good judgment, be flexible when different tasks arise, and be detailed oriented.

Job Responsibilities:

• Work with the clinical team to support the design, development, execution, and delivery of the clinical study in accordance with the clinical development plan/strategy and timelines
• Collaborate closely with the Associate Director of Clinical Operations, working on execution and oversight of sponsored clinical trials
• Support in the oversight of CRO activities and other clinical vendors to ensure study quality meets Biogen’s and regulatory requirements
• Support the Associate Director of Clinical Operations and medical writers to initiate protocols, study reports, Investigator Brochures, and other key clinical documents
• Manage escalation of study related issues and communicates as appropriate with management and other R&D functions
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
• Collaborate with the cross functional teams on clinical activities (drug supply, resolution of data queries, etc.) and on selection and management of clinical vendors
• Maintain knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities

Critical Competencies:
• 3-5+ years of project management experience
• Experience working with cross-functional teams
• Demonstrated experience in management of vendors, including contracts and budgets


Behavioral and Interpersonal:
• Exceptional attention to detail and excellent organizational skills with a desire to roll up one’s sleeves
• Excellent oral and written communication skills
• Ability to thrive in a dynamic and fast-paced environment
• Ability to prioritize duties and manage multiple matters from start to finish with minimal supervision with a demonstrated ability to lead change and make independent decisions
• Ability to effectively and positively work with executive-level management
• Ability to handle highly confidential and sensitive materials and information with complete discretion and having good judgment in working with clients, and occasionally under ambiguous or challenging circumstances
• A dynamic self-starter with a positive attitude and strong influencing skills

Education:

Bachelor’s degree, nursing background is also acceptable

All your information will be kept confidential according to EEO guidelines.