Job Description
About This Role
This is a North American Clinical Operations role (covering the US and Canada but the position must be based within the US), focusing on providing key local operational & scientific expertise to drive, shape delivery and execution of the R&D pipeline. This role will be integrating the needs of KME and external stakeholder engagements and represent local Biogen at in-country industry and scientific meetings as well as at patient organizations/meetings.
Additionally, this role also acts as a representative for Country & Site Operations (CSO) for required review of global initiatives, as well as participate as SME representing the whole of department.
An important part of this role is acting as operational expert in Clinical Operations managing related functions including line management and external providers (FSP).
What You'll Do
- Support, develop, and implement Clinical Trial Sites engagement strategies
- Direct Line management of Clinical Country and Site Leads
- Work in different operating models (FSO & FSP)
- Support and lead initiatives related to Clinical Operations with heavy cross functional collaboration with Biogen stakeholders and external stakeholders.
- As part of CSO global LT, contribute to strategic initiatives and support shaping the goals and evolvement of the department.
Who You Are
Someone with passion to work in a team who is flexible, will count on your expertise and passioned about finding new ways to making Site Engagement and Clinical Operations efficient and successful aiming to bring treatment to the market faster to patients.
Qualifications
Required Skills
- Bachelor's degree required. Advanced degree preferred.
- Requires 12+ years' experience in clinical development/operations.
- Experience across multiple clinical operations disciplines including field-based site-facing clinical operations roles, clinical trial delivery via an outsourcing model.
- People management experience required.
- Strong understanding of regulatory environment regarding GCP, clinical trial regulations, and regulatory guidance pertinent to clinical trial conduct in assigned regions. (US and Canada)
- Strong interpersonal and communication skills, including experience working with various senior management levels.
- Ability to travel up to 30% within the US and Canada required.
Preferred Skills
- R&D project leadership experience preferred.
- Experience in FSP environment preferred.
- Advanced degree preferred.
Additional Information
The base compensation range for this role is $174,000 - $290,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
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.