Senior Ophthalmology Development Leader

Biogen, Inc.

Cambridge (MA)

On-site

USD 274,000 - 377,000

Full time

3 days ago
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Benefits offered by this job

Medical, Dental, Vision, & Life ins.
Fitness & Wellness programs
Paid vacation and holidays
Sick time & parental leave
401(k) with company match
Employee stock purchase plan
Tuition reimbursement
Employee Resource Groups

Job summary

Biogen is seeking a Senior Medical Director, Ophthalmology, to lead clinical and strategic development across the ophthalmology portfolio, from early development through regulatory approval and lifecycle management. You will align scientific priorities with clinical, regulatory, and business goals, guiding decision-making and execution with cross-functional teams.

The role requires extensive ophthalmology experience, leadership, and global regulatory interaction, with a focus on translating

Qualifications

  • Board certified ophthalmologist (MD, DO, or foreign equivalent)
  • 15+ years of experience
  • 8+ years in ophthalmology clinical development
  • 3-5 years of leadership experience within biotech or pharmaceuticals, with direct responsibility for program strategy and execution
  • Demonstrated success leading ophthalmology clinical programs across multiple development phases
  • Experience working with global regulatory agencies and presenting at advisory committee meetings
  • Deep knowledge of ophthalmic diseases, clinical practice, and emerging therapies, with expertise across preclinical, clinical, and regulatory development
  • Ability to integrate scientific, clinical, and business considerations into development strategy
  • Ability to communicate complex concepts clearly to executive leaders, regulatory authorities, and external partners
  • Demonstrated leadership and influence across functions to guide critical development decisions
  • Ability to navigate ambiguity, anticipate challenges, and develop innovative solutions that advance programs efficiently

Responsibilities

  • Lead ophthalmology development strategy as the Development representative on cross-functional teams, aligning research, clinical, and commercial priorities
  • Develop and execute integrated asset plans, target product profiles, and lifecycle management strategies, incorporating emerging science and clinical insights
  • Oversee Development deliverables across preclinical, chemistry, manufacturing and controls (CMC), and clinical activities, supporting timelines, scientific rigor, and regulatory readiness
  • Serve as Ophthalmology Therapeutic Area Lead, guiding clinical trial design and delivery from first-in-human studies through post-marketing
  • Provide or supervise medical monitoring, including serious adverse event review, medical coding, data interpretation, and safety oversight
  • Ensure the medical and scientific integrity of study reports, publications, and regulatory documents; author and review clinical sections of INDs, CTAs, NDAs, BLAs, and briefing materials
  • Partner with Regulatory Affairs on submission strategy, health authority consultations, and advisory committee preparation; represent Biogen with global health authorities
  • Provide internal and external ophthalmology expertise on disease trends and treatment landscapes, and contribute clinical and scientific assessments of licensing and partnership opportunities
  • Represent Clinical Development in leadership forums, aligning program priorities, risks, and execution with commercial, regulatory, and technical operations planning
  • Coach and mentor direct reports and cross-functional colleagues, building scientific excellence, accountability, innovation, and organizational capability

Skills

Ophthalmologist MD/DO
15+ years exp
Ophthalmology development
Leadership experience
Regulatory interaction
Cross-functional collab
Exec communications

Job description

Biogen is seeking a Senior Medical Director, Ophthalmology, to lead clinical and strategic development across the ophthalmology portfolio, from early development through regulatory approval and lifecycle management. You will align scientific priorities with clinical, regulatory, and business goals, guiding decision-making and execution with cross-functional teams.

The role requires extensive ophthalmology experience, leadership, and global regulatory interaction, with a focus on translating

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