Director, Early Development - Clinical Science

Director, Early Development - Clinical Science

Irvine, California, United States

The Director, Early Development - Clinical Sciences will create early development clinical plans, program outlines, study designs and clinical study essential documents. This individual will be accountable for leading the cross-functional Study Teams to meet study deliverables and represent clinical development in core team and investigator meetings as needed.

This role will collaborate closely with cross-functional teams such as Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, Finance and Legal to drive efficient and scientifically rigorous early development clinical work.

• Maintains direct ownership of early development clinical deliverables, actively contributing to protocol development, document authoring, data review, study-level problem solving and execution decisions to ensure scientific rigor and operational excellence.
• Shape clinical plans including timelines, budgets and oversight of clinical teams.
• Author and critically review key clinical and regulatory documents, including protocols, SAPs, CSRs, IBs and clinical value dossiers, ensuring scientific rigor, regulatory alignment and quality execution.
• Lead and oversee the training of study investigators on protocol and on clinical trial procedures.
• Conduct research to develop foundational education material to inform the early development program 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 with internal and external stakeholders, including KOLs and regulators.
• Exhibits and fosters key leadership competencies, including an innovative mindset, strong business acumen, an outcome-driven orientation, and a commitment to growing and expanding the capabilities and capacity of the team.
• Collaborate with Clinical Operations, Regulatory Affairs, Translational Sciences, Biostatistics, Medical Affairs and others to ensure robust trial design, scientific and operational alignment and execution.

• Advanced degree in sciences (e.g. Pharm
  
  D, MD, PhD) with deep experience in early clinical development.
• Experience in ophthalmology preferred; dermatology or infectious diseases a plus.
• Minimum of 10 years of biotech/pharmaceutical clinical development experience, with at least 8 years of leadership in clinical trial management.
• Established leadership track record with evidence of excellent performance-based people management, problem solving, collaboration, cross-functional leadership and effective communication skills.
• Expertise with SOPs, GCPs and regulatory and compliance guidelines for clinical trials.
• Must be willing to be “hands on” and delve into details.

• 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 – Fosters trust and psychological safety, navigating complex interpersonal dynamics with compassion and accountability, and adapting leadership style to support others while maintaining composure under pressure.

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work…