This role is part of the Clinical Trial Accelerator Unit (CTAU) and will partner with the Head of Study Start Up Operations to drive and manage its robust FSP insourcing model. This role oversees a team of FSP staff: including Regional Leads, SSU Specialists and Essential Document Reviewers to ensure fit for purpose resourcing and consistent approach, embedding efficient processes across the function. It ensures alignment with SSU’s key internal and external stakeholders on FSP role execution and performance to secure alignment in direction and delivery.
What You’ll Do- Provide day-to-day oversight of SSU FSP staff: eg Regional Leads, Study Start Up Specialists and Essential document reviewers, as required to deliver on Start Up activities across the portfolio.
- Be the point of contact for FSP service provider for SSU resourcing issues and questions.
- Lead resource forecasting and resource planning to meet key business drivers and maximize FSP performance within annual operating plan
- Real-time, agile resource allocation for EDP reviewer role as required
- Involves mapping out EDP reviews across all studies including amendments
- Real-time, agile allocation of SSU Specialists as required to ensure coverage for activations, along with amendments and yearly IRB submissions
- Oversee onboarding and offboarding of FSP resources including meet and greets, ensuring smooth transitions, training and policy compliance.
- Work with the start up team to develop and revise role-specific SOPs to drive consistency and quality across FSP staff
- Represent SSU group in FSP oversight activities and monitor and report applicable FSP role performance activities
- Partner with SSU stakeholders to align on goals and promote continuous improvement.
- B.A. or B.S. in a scientific discipline; advanced degree preferred
- 10+ years in Clinical Research with 5+ years in global start-up
- Start Up experience across multiple studies and programs, with the agility to adapt to an evolving pipeline and with the ability to apply this knowledge to inform resource demand forecasting and algorithm refinement
- Proven ability to manage and oversee FSP staff, including resource planning, training, and performance management.
- Ability to leverage comprehensive knowledge of key business drivers to maximize FSP staff performance.
- Effective line management and mentoring skills, with the ability to build strong relationships across all organizational levels.
- Excellent leadership, communication, and organizational skills, with strengths in problem solving, conflict resolution, and team building.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development.
- Strong project management capabilities with a proactive mindset
- Collaborative mindset with the ability to partner effectively with internal and external stakeholders.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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.
Top Skills
What We Do
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, 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. Biogen also manufactures and commercializes biosimilars of advanced biologics. With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
