Senior Director, Global Clinical Development, Neuroscience

Position Summary / Objective

• - Serve as clinical point of accountability for the Clinical Development Team; own overall clinical development plan for assets in one or more indications.
• - Provide matrix leadership, develop teams, and ensure studies meet regulatory, quality, medical, and access goals.

• - Medical Monitoring: independent Medical Monitor; articulate clinical development strategy; analyze/interpret/act on clinical trial data; principal functional author for regulatory submissions, study reports, and publications. Design/develop clinical studies and research plans.
• - Clinical Development Expertise & Strategy: manage multiple complex programs; contribute to indication strategy; partner with Patient Safety physicians for safety review; provide disease area expertise; work with KOLs; evaluate options vs. TPP; collaborate on asset risk management; resolve quality/clinical issues; set execution priorities; ensure top-line data; define dose/schedule, indications, and patient selection (biomarkers).
• - Health Authority Interactions: primary clinical representative in regulatory interactions; own clinical contributions to CSRs, regulatory reports, briefing books, and submissions.
• - External Partnerships/Publications: establish relationships with investigators; alliances with academic centers, co-op groups, vendors, and agencies; represent department in due diligence/partner management; track record of field contributions.
• - Leadership/Matrix Management: may manage Clinical Trial Physicians and Clinical Scientists; ensure training/mentoring; ensure GCP/compliance.

• - MD or MD/PhD; deep clinical expertise in a therapeutic area. Fellowship/specialty training preferred.

• - 7+ years in discovery, translational and/or clinical research (academia/industry).
• - Extensive clinical trial design/execution, biomarker development, and development strategy in pharma.
• - Extensive clinical development experience in neurodegenerative and/or neuropsychiatric indications (required). Basic research expertise in neurodegeneration/neuropsychiatry (plus).

• - Clinical development strategy (including regulatory submission components); external partnership/relationship building.

• - Domestic and international travel may be required.

• - Health coverage (medical/pharmacy/dental/vision); wellbeing support; 401(k), disability, life insurance, and other financial protections.
• - Paid time off: flexible time off (unlimited, manager approval, 11 paid national holidays) or 160 hours annual vacation (with manager approval), 11 national holidays, plus 3 optional holidays (per eligibility).