Sr. Clinical Trial Physician, Neuropsychiatry

Role Summary

Senior Clinical Trial Physician, Neuropsychiatry provides medical accountability and oversight for multiple clinical trials within a global development program. The role leads medical data review, safety assessment, and protocol development with cross-functional teams, applying medical and scientific expertise to trial design and execution across Phase 1–3. It requires matrix leadership across internal and external partners and the ability to communicate complex medical information clearly to investigators and stakeholders.

• Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Clinical Development Team (CDT)
• Leads medical data review of trial data, including eligibility review
• Manages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)
• Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
• Leads collaboration with the Clinical Scientist and provides medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training

• In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strategic focus based on asset/drug knowledge, disease area, and relevant science to meet regulatory and disease strategy targets
• Provides oversight and medical accountability for a group of studies
• Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment with Clinical Scientists
• Partners with Clinical Scientists to support executional delivery of studies (site activation, enrollment status, and adjudication for protocol violations or deviations)
• Identifies and builds relationships with principal investigators and thought leaders to incorporate emerging science into study design
• Maintains a strong medical/scientific reputation in the disease area and stays current with etiology, natural history, diagnosis, and treatment
• Keeps abreast of development and regulatory issues related to competitive compounds and portfolio fit
• Provides ongoing medical education with Clinical Scientists to enable protocol-specific training for the study team and investigators

• Contributes as medical point of expertise in Health Authority interactions and advisory board meetings
• Authors or drafts clinical content for CSRs, regulatory reports, briefing books, and submission documents in collaboration with Clinical Scientists

• MD required (or x-US equivalent)

• Experience Requirements: 5 or more years of clinical trial experience, either in industry or academic setting
• Subspecialty training in applicable therapeutic area desirable
• Ability to communicate information clearly and lead presentations in scientific and clinical settings
• Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
• Expertise in the drug development process
• Expertise in the components needed to execute an effective clinical plan and protocols
• Strong leadership skills with proven ability to lead and work effectively in a team environment

• Clear, effective communication and presentation abilities in scientific and clinical settings
• Strategic thinking in clinical development and protocol design
• Strong collaboration and relationship-building with investigators and cross-functional teams
• Analytical capabilities to assess safety data and benefit/risk

• Travel:
  Domestic and International travel may be required