Senior Immunology Clinical Development Lead

Regulatory Jobs; Cambridge (MA); On-site; USD 274,000 - 377,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Fitness reimbursement

Disability insurance

Vacation & shutdown time

Company holidays

Parental leave

401(k) match

Employee stock plan

Tuition reimbursement

Job summary

Biogen is seeking a Sr. Medical Director in Immunology to lead clinical development planning and execution across early assets to registration and post-approval.

You will shape the Clinical Development Plan and collaborate with cross-functional teams and external partners to drive development programs forward. You will provide critical clinical insights for early assets, engage with global regulators, and lead BD due diligence activities as part of R&D leadership.

Qualifications

• MD or MD, PhD with training/experience in immunology.
• 3–5 years in clinical development within pharma/biotech.
• Experience leading registration-stage programs and/or early clinical development with IND filings.
• Significant interaction with global regulatory authorities.
• Business development experience including due diligence.

Responsibilities

• Develop and implement the Clinical Development Plan for clinical pipeline and research assets.
• Lead and oversee the clinical development of early-stage assets through to registration and post-approval.
• Provide clinical insights for early development assets that have not completed R2D transition.
• Offer clinical input for assets in partnership with external partners and/or for in-licensing activities.
• Act as R&D Project Lead, ensuring accountability for an asset throughout development activities.
• Serve as a member of the functional leadership team, providing insights on broader strategy.
• Influence senior cross-functional counterparts across research, development, medical business, and commercial functions.
• Engage with global regulatory authorities.
• Lead registration-stage programs and/or early clinical development programs with experience filing INDs.
• Participate in business development activities, including due diligence.
• Collaborate with MSIDU leadership, Immunology Franchise, and external innovation partners.

Skills

MD/PhD immunology

Clinical development leadership

IND filings

Regulatory engagement

Business development due diligence

Education

Medical degree (MD)

Job description

Biogen is seeking a Sr. Medical Director in Immunology to lead clinical development planning and execution across early assets to registration and post-approval.

You will shape the Clinical Development Plan and collaborate with cross-functional teams and external partners to drive development programs forward. You will provide critical clinical insights for early assets, engage with global regulators, and lead BD due diligence activities as part of R&D leadership.