Director, Early Development - Clinical Science

Welcome to the Tarsanet Internal Career Center!•Irvine, CA

77d•$203,200 - $284,600•Hybrid

About The Position

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.

Requirements

Advanced degree in sciences (e.g. PharmD, MD, PhD) with deep experience in early clinical development
Minimum of 10 years of biotech/pharmaceutical clinical development experience, with a minimum of 8 years leadership in clinical trial management experience required
Established leadership track record with evidence of excellent performance-based people management experience, 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

Nice To Haves

Experience in ophthalmology is preferred; dermatology or infectious diseases a plus.

Responsibilities

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 oversees 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.