Director, Early Clinical Development - CNS

Key Responsibilities

• Serve as scientific and clinical expert in CNS translational medicine and early clinical development, contributing to strategic program decisions; serve as ECD lead on development teams for multiple assets.
• Drive Research-to-Development (R2D) strategies and stage-gate decision-making, including indication prioritization and go/no-go based on mechanistic rationale, benefit-risk, and clinical unmet need as well as on clinical and/or biomarker driven endpoints.
• Prepare and present decision-quality data packages for internal governance reviews to support stage-gate decisions.
• Interact with internal and external groups to evaluate new compounds, molecular and biological targets as well as new formulation technologies.
• Partner with internal and external research organizations to expand and facilitate development of early phase and discovery phase compounds.
• Engage with external experts and key opinion leaders to inform translational and Proof of Concept (PoC) strategy and maintain scientific leadership.
• Represent ECD in cross functional as well as internal/external collaborations (BD, etc.) on activities related to early phase target and asset identification.
• Support regulatory interactions (e.g., pre-IND, IND submissions) and ensure translational strategies align with regulatory requirements.
• Lead scientific and clinical development efforts for assigned programs from target identification through IND and proof-of-concept.
• Provide medical leadership for early-phase clinical protocols, informed consent forms, and investigator brochures; monitor safety and contribute to DSMB or safety review activities as needed.
• Support or lead or public-private partnerships operating in pre-competitive settings to advance internal clinical development capabilities.
• Interact with other disciplines within the EDO to promote, initiate and elevate cross-functional early development activities.
• Collaborate with biomarker and digital innovation teams to develop and implement biomarker-driven approaches for CNS programs.
• Support the development of team members to build translational and early clinical development expertise.
• Travel 20%

Qualifications

• Required MD, MD/PhD, or PhD with subspecialty training in Clinical psychology/neuropsychology
• 5+ years of translational medicine and/or early clinical development experience with a track record of advancing biologics and/or small molecules through IND and FIH/PoC.
• Expert understanding of industry best practices and adjacent functional areas.
• Demonstrated ability to coordinate and guide cross-functional teams in matrixed, global setting, with solid strategic thinking and the ability to make informed decisions amid uncertainty.
• Outstanding communication skills with the ability to synthesize complex data and influence executive stakeholders.
• Preferred MD with specialty training in psychiatry and/or neurology.
• Deep expertise in CNS, particularly psychiatry, neurodegenerative disease, and/or neuroinflammation.
• Experience implementing clinical study plans to drive decision-making.
• Experience with external collaborations.