Associate Medical Director, Rare Neurology Outcome Development
B
BiogenBiotechnology, Rare Diseases
Remote, USAFull-TimeManager
Salary$184,000.00-$253,000.00
Apply NowOpens the employer's application page
Job Details
- Experience
- 5 years
- Required Skills
- Project ManagementGCP
Requirements
- Ph.D., MD, and/or PharmD degree.
- 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.
- 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.
Responsibilities
- 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.
View Full Description & ApplyYou'll be redirected to the employer's site
