Rare Neurology Outcomes Strategy Lead

Biogen, Inc.; United States; Remote; USD 184,000 - 253,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Paid time off

401(k) match

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen, Inc. seeks an Associate Medical Director, Rare Neurology Outcome Development to lead development of novel outcome measures and evidence generation strategies across the Rare Neurology portfolio.

You will work with cross-functional teams to advance biomarkers, digital endpoints, and clinical outcome assessments throughout product development. The role emphasizes collaboration with internal and external stakeholders, including regulatory authorities, and requires deep expertise in trial

Qualifications

• Ph.D., MD, or PharmD with 5+ years of clinical research experience.
• Experience with Clinical Outcome Assessment strategy, including development, validation and qualification of endpoints.
• Experience in analyzing and interpreting clinical trials.
• Knowledge of GCP, trial design, biostatistics, and regulatory requirements for clinical studies.
• Strong organizational and cross-functional collaboration skills.

Responsibilities

• Support development, qualification, and implementation of novel outcome measures, including biomarkers and digital endpoints across the Rare Neurology portfolio.
• Contribute to evaluation and refinement of existing outcome measures using internal and external datasets.
• Assist design and execution of outcome development studies and natural history studies.
• Collaborate with internal and external experts to advance patient-centered approaches to outcome measurement.
• Contribute to endpoint strategy discussions for clinical programs and support regulatory interactions.
• Support scientific communications, publications, and external collaborations related to outcome development.

Skills

Clinical research

COA strategy

Trial interpretation

GCP & biostatistics

Project management

Stakeholder collaboration

Education

Ph.D./MD/PharmD

Job description

Biogen, Inc. seeks an Associate Medical Director, Rare Neurology Outcome Development to lead development of novel outcome measures and evidence generation strategies across the Rare Neurology portfolio.

You will work with cross-functional teams to advance biomarkers, digital endpoints, and clinical outcome assessments throughout product development. The role emphasizes collaboration with internal and external stakeholders, including regulatory authorities, and requires deep expertise in trial