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.
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.
Nice to Have
- Experience in ophthalmology is preferred; dermatology or infectious diseases a plus.
Benefits
- health, dental and vision insurance benefits to ensure your well-being.
- generous paid time off, including vacation, holidays, and personal days.
Additional Information
- Some travel may be required – up to 30%
