Responsibilities:
- Provide scientific leadership to cross-functional study and program teams to ensure timely start-up, enrollment, database lock, analysis, and readouts.
- Lead design of clinical development plans and individual study protocols (objectives, endpoints, inclusion/exclusion, assessments, statistical assumptions).
- Own clinical deliverables end-to-end: protocol development, document authoring, data review, and study-level problem solving.
- Shape clinical plans including timelines, budgets, and oversight of clinical teams.
- Build relationships with investigators, KOLs, and external partners; contribute to publication strategy and scientific communications.
- Drive innovation in clinical endpoints, biomarkers, and digital tools; continuously improve clinical science processes and data review frameworks.
- Author and critically review clinical and regulatory documents (protocols, SAPs, CSRs, IBs, clinical value dossiers) for scientific rigor and regulatory alignment.
- Conduct research to develop foundational education materials for early development strategies.
- Interpret clinical data and support data-driven decisions.
- Serve as program lead on early development core teams, investigator meetings, and scientific advisory boards.
- Engage internal/external stakeholders including KOLs and regulators; collaborate with Clinical Operations, Regulatory, Translational Sciences, Biostatistics, and Medical Affairs.
Qualifications:
- Advanced degree (e.g., PharmD, MD, PhD) with deep experience in early clinical development.
- Ophthalmology experience preferred (dermatology or infectious diseases a plus).
- 10+ years biotech/pharmaceutical clinical development; 8+ years in leadership for clinical trial management.
- Leadership track record in people management, problem solving, collaboration, cross-functional leadership, and communication.
- Expertise with SOPs, GCPs, and regulatory/compliance guidelines.
- Must be willing to be βhands onβ and work through details.
Benefits/Other:
- Hybrid work environment; remote work option; Irvine office-based.
- Travel up to 30%.
- Health, dental, and vision insurance; paid time off.
Expected base pay range: $255,000β$357,000 plus bonus and stock equity.