Senior Medical Director, Opthalmology

Biogen, Inc.

Cambridge (MA)

Vor Ort

USD 274.000 - 377.000

Vollzeit

Vor 3 Tagen
Sei unter den ersten Bewerbenden

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Benefits dieser Stelle

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

Zusammenfassung

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

Qualifikationen

  • 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

Aufgaben

  • 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

Kenntnisse

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

Jobbeschreibung

About This Role As Senior Medical Director, Ophthalmology, you will lead the clinical and strategic development of Biogen's ophthalmology programs, from early development through regulatory approval and lifecycle management. You will serve as the lead Development representative on cross-functional strategy and development teams, connecting scientific priorities with clinical, regulatory, and business goals. Reporting to the Head of Immune Mediated and Neurodegenerative Diseases, you will shape program strategy and provide clinical oversight and medical monitoring leadership. Working closely with Research, Medical Affairs, Regulatory Affairs, Corporate Strategy, and other partners, you will guide development decisions and align execution across the portfolio.

What You'll Do
  • 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
Who You Are

You connect ophthalmology expertise with a strategic view of drug development and translate complex scientific and clinical information into clear decisions. You build alignment across functions, mentor colleagues, and navigate ambiguity while keeping programs moving forward.

Required Skills
  • 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

Job Level: Management

Additional Information

The base compensation range for this role is: $274,000.00-$376,750.00 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.

  • 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 Biogen.

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.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.

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