Director, Early Development - Clinical Science
$203,200–$284,600 year
HybridIrvine, California, United States
Job Summary
Create early development clinical plans, program outlines, study designs, and essential documents while maintaining direct ownership of deliverables. Lead cross-functional Study Teams to meet study goals, shape clinical timelines and budgets, and oversee investigator training. Author and critically review protocols, SAPs, CSRs, and clinical value dossiers to ensure regulatory alignment and scientific rigor. Interpret clinical data to support data-driven decisions and serve as program lead on Core teams, investigator meetings, and scientific advisory boards. Engage with KOLs and regulators to drive efficient, scientifically rigorous early development work.
Required Qualifications
- Advanced degree in sciences (e.g. PharmD, MD, PhD)
- Deep experience in early clinical development
- Minimum of 10 years of biotech/pharmaceutical clinical development experience
- Minimum of 8 years leadership in clinical trial management experience
- Established leadership track record with evidence of excellent performance-based people management experience
- Problem solving
- Collaboration
- Cross functional leadership
- Effective communication skills
- Expertise with SOPs
- Expertise with GCPs
- Expertise with regulatory and compliance guidelines for clinical trials
- Must be willing to be 'hands on' and delve into details
- Mastery of the Tarsus Leadership Competencies for Leading People
- Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals
- Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning
- Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results
- Empowering Others - Fosters empowerment by aligning authority with accountability, developing leaders' decision-making capability, and creating systems that support performance and growth
- Emotional Intelligence - Foster trust and psychological safety, navigating complex interpersonal dynamics with compassion and accountability, and adapting leadership style to support others while maintaining composure under pressure
- Some travel (up to 30%)
Desired Qualifications
- Experience in ophthalmology
- Dermatology experience
- Infectious diseases experience
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.