Summary

As the Senior Director, Head of Clinical Trial Start-Up, you will spearhead Biogen’s global study activation strategy, ensuring seamless execution across our clinical development portfolio. Leading multidisciplinary teams, you will align activation capabilities, systems, and processes with Biogen’s strategic priorities, directly contributing to our vision of pioneering scientific breakthroughs. Your role is pivotal in providing both strategic and operational leadership for study start-up, site activation, contracting, budgeting, and EU-CTR strategy. You will transform activation capabilities through technology, process innovation, and automation, ensuring inspection-ready delivery across regions and therapeutic areas. Managing resources, developing talent, and fostering a culture of continuous improvement are integral to your success as you drive forward our global clinical operations.

Job description

About This Role

As the Senior Director, Head of Clinical Trial Start-Up, you will spearhead Biogen’s global study activation strategy, ensuring seamless execution across our clinical development portfolio. Leading multidisciplinary teams, you will align activation capabilities, systems, and processes with Biogen’s strategic priorities, directly contributing to our vision of pioneering scientific breakthroughs. Your role is pivotal in providing both strategic and operational leadership for study start-up, site activation, contracting, budgeting, and EU-CTR strategy. You will transform activation capabilities through technology, process innovation, and automation, ensuring inspection-ready delivery across regions and therapeutic areas. Managing resources, developing talent, and fostering a culture of continuous improvement are integral to your success as you drive forward our global clinical operations.

What You’ll Do

Lead global study activation from protocol finalization through site initiation and activation.
Build and sustain a team dedicated to delivering study start-up quality and compliance while meeting milestone time requirements.
Evaluate and refine processes and systems to create scalable, efficient, and compliant study activation frameworks.
Govern outsourced activation activities, including vendor oversight and contractual management.
Align cross-functionally with Regulatory, Legal, Finance, Quality, and Medical teams to streamline execution.
Strengthen global activation competencies and talent pipeline within Biogen.
Drive integration and visibility across data and systems for transparent performance assessment and strategic opportunity identification.

Who You Are

You are a visionary leader with a strategic mindset, capable of translating vision into executable plans. Your high emotional intelligence allows you to navigate ambiguous environments with resilience, influencing without authority across matrixed organizations. You possess exceptional stakeholder management skills, and your executive presence enables you to represent functions in senior forums. You are driven by the pursuit of excellence, continuously seeking improvements and fostering innovation.

Required Skills

Bachelor’s degree required; advanced degree (MBA, MPH, PharmD, PhD) preferred.
At least 12 years of experience in study start-up, clinical study/trial activation leadership.
Extensive project management skills and experience in global cross-functional delivery.
Exceptional critical thinking and problem-solving skills.
Robust understanding of clinical development processes and regulatory environment.
Strong executive presence and ability to represent functions in senior executive forums.

Preferred Skills

Experience with digital/technology transformation in clinical trials.
Strong decision-making and risk management orientation.
High emotional intelligence and resilience in ambiguous environments.

Requirements

Bachelor’s degree required; advanced degree (MBA, MPH, PharmD, PhD) preferred.
At least 12 years of experience in study start-up, clinical study/trial activation leadership.
Extensive project management skills and experience in global cross-functional delivery.
Exceptional critical thinking and problem-solving skills.
Robust understanding of clinical development processes and regulatory environment.
Strong executive presence and ability to represent functions in senior executive forums.
Experience with digital/technology transformation in clinical trials (preferred).
Strong decision-making and risk management orientation (preferred).
High emotional intelligence and resilience in ambiguous environments (preferred).

Benefits

Medical, Dental, Vision & Life insurances
Fitness & Wellness programs
Short- and Long-Term Disability insurance
Paid vacation (min 15 days)
End-of-year shutdown time off
12 company paid holidays
3 paid days for Personal Significance
80 hours sick time per year
Paid Maternity and Parental Leave
401(k) with company match
Employee stock purchase plan
Tuition reimbursement up to $10,000/year
Employee Resource Groups

Company overview

Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.