Immunology Clinical Development Lead — Reg & Deals

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 Insurance
Dental Insurance
Vision Insurance
Life Insurance
Fitness & Wellness programs
Disability insurance — short & long
Vacation and shutdown time off

Job summary

Biogen in Cambridge, MA seeks a Sr. Medical Director specializing in Immunology to drive clinical development strategy across the pipeline and research assets.

You will craft and implement the Clinical Development Plan, lead early-stage asset programs to registration and post-approval, and provide critical insights for assets not yet through R2D transition. You will collaborate with external partners, drive regulatory interactions, support business development due diligence, and participate in

Qualifications

  • MD or MD/PhD with immunology training; subspecialty in rheumatology/dermatology considered.
  • 3–5 years in clinical development within pharma/biotech; IND filing experience.
  • Significant interaction with global regulatory authorities; business development due diligence.

Responsibilities

  • Develop and implement the Clinical Development Plan for pipeline and research assets.
  • Lead clinical development of early-stage assets through registration and post-approval.
  • Provide clinical insights for early development assets not yet through R2D transition.
  • Offer clinical input for assets in partnerships and in-licensing activities.
  • Act as R&D Project Lead, ensuring asset accountability.
  • Contribute to the functional leadership team and cross-functional strategy.
  • Engage with global regulatory authorities and lead registration-stage programs.

Skills

MD/PhD immunology
Clinical development
IND filings
Regulatory interaction

Education

MD or MD/PhD

Job description

Biogen in Cambridge, MA seeks a Sr. Medical Director specializing in Immunology to drive clinical development strategy across the pipeline and research assets.

You will craft and implement the Clinical Development Plan, lead early-stage asset programs to registration and post-approval, and provide critical insights for assets not yet through R2D transition. You will collaborate with external partners, drive regulatory interactions, support business development due diligence, and participate in

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