Associate Medical Director, Rare Neurology Outcome Development
Biogen
Summary
We are seeking a highly motivated Associate Medical Director, Rare Neurology Outcome Development to support the development and implementation of innovative outcome measures and integrated evidence generation strategies across our Rare Neurology portfolio. Working closely with the Rare Neurology Outcome Development Lead and cross-functional colleagues, this individual will contribute to the evaluation, refinement, and operationalization of biomarkers, digital endpoints, clinical outcome measures, and evidence generation approaches that support development in therapeutic areas in the Rare Neurology Development Unit.
Job description
About This Role
We are seeking a highly motivated Associate Medical Director, Rare Neurology Outcome Development to support the development and implementation of innovative outcome measures and integrated evidence generation strategies across our Rare Neurology portfolio. Working closely with the Rare Neurology Outcome Development Lead and cross-functional colleagues, this individual will contribute to the evaluation, refinement, and operationalization of biomarkers, digital endpoints, clinical outcome measures, and evidence generation approaches that support development in therapeutic areas in the Rare Neurology Development Unit.
What You’ll Do
- Support the development, qualification, and implementation of novel outcome measures, including biomarkers, digital endpoints, and clinical outcome assessments across the Rare Neurology portfolio.
- Contribute to the evaluation and refinement of existing outcome measures using internal and external datasets.
- Support the design and execution of outcome development studies, natural history studies, and methodology research initiatives.
- Collaborate with internal and external experts to advance patient-centered approaches to outcome measurement.
- Contribute to endpoint strategy discussions for clinical development programs and support interactions with regulatory authorities and external stakeholders.
- Support scientific communications, publications, congress presentations, and external collaborations related to outcome development.
- Partner with program teams and functional stakeholders to contribute to Integrated Evidence Plans and align evidence generation activities with key development objectives.
Who You Are
You are a driven team member who can think globally about advancing endpoint development and work effectively with cross-functional partners across multiple studies within the rare neurology space. You have a strong understanding of outcome development, evidence generation, clinical trial design, and interpretation of clinical trial results.
Requirements
- Ph.D., MD, and/or PharmD and 5 years of clinical research experience (academia and/or industry).
- Experience with Clinical Outcome Assessment strategy and implementation including outcome measure development, validation, and qualification and/or endpoint selection for clinical trials.
- Experience in analyzing and interpreting clinical trials.
- Demonstrated knowledge of GCP, clinical trial design and execution, biostatistics, and regulatory requirements for clinical studies.
- High level of organizational and project management skills with the ability to work collaboratively in a fast-paced, team-based global matrix environment.
- Demonstrated success in interacting and building relationships with various internal/external stakeholders, such as Clinical Operations, Regulatory, Biostatistics, and clinical investigators.
Benefits
- Medical, Dental, Vision & Life insurances
- Fitness & Wellness programs
- Short- and Long-Term Disability insurance
- 15 days paid vacation
- End-of-year shutdown time off
- 12 company paid holidays
- 3 paid days for Personal Significance
- 80 hours sick time
- Paid Maternity and Parental Leave
- 401(k) with company match
- Employee stock purchase plan
- Tuition reimbursement up to $10,000
- Employee Resource Groups participation
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.