Associate Medical Director, Rare Neurology Outcome Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the development, qualification, and implementation of innovative outcome measures, such as biomarkers, digital endpoints, and clinical outcome assessments within the Rare Neurology portfolio.

• Assess and enhance existing outcome measures utilizing both internal and external datasets.

• Aid in the design and execution of outcome development studies, natural history studies, and methodological research initiatives.

• Collaborate with internal and external specialists to promote patient-centered methodologies in outcome measurement.

• Participate in endpoint strategy discussions for clinical development initiatives.

• Facilitate interactions with regulatory bodies and external stakeholders.

• Contribute to scientific communications, publications, congress presentations, and external collaborations related to outcome development.

• Collaborate with program teams and functional stakeholders to support Integrated Evidence Plans.

• Ensure that evidence generation activities align with critical development objectives.

⛳️ Requirements

• Ph.D., MD, and/or PharmD with 5 years of clinical research experience, either in academia or industry.

• Proficiency in Clinical Outcome Assessment strategy and implementation, including development, validation, and qualification of outcome measures and/or endpoint selection for clinical trials.

• Experience in analyzing and interpreting data from clinical trials.

• Proven knowledge of GCP, clinical trial design and execution, biostatistics, and regulatory standards for clinical studies.

• Exceptional organizational and project management capabilities.

• Ability to work effectively in a fast-paced, team-oriented global matrix environment.

• Documented success in engaging and building relationships with internal and external stakeholders, including Clinical Operations, Regulatory, Biostatistics, and clinical investigators.

• Preferred: Background in Epidemiology, Clinical Development, HEOR, or Evidence Generation.

• Preferred: Experience in neurology and/or rare diseases.

• Preferred: Involvement in pipeline portfolio strategy or therapeutic area strategy.

• Preferred: Knowledge of biomarkers, wearables, and digital health technologies.

• Preferred: Strong written and verbal communication abilities.

• Willingness to travel to scientific meetings and clinical sites occasionally as required (domestic and international).

🏝️ Benefits

• Medical, Dental, Vision, & Life insurances.

• Fitness & Wellness programs, including fitness reimbursement.

• Short- and Long-Term Disability insurance.

• A minimum of 15 days of paid vacation.

• Additional end-of-year shutdown time off (December 26-31).

• Up to 12 company-paid holidays plus 3 paid days off for Personal Significance.

• 80 hours of sick leave per calendar year.

• Paid Maternity and Parental Leave benefit.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan.

• Tuition reimbursement up to $10,000 per calendar year.

• Involvement in Employee Resource Groups.

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.