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Senior Vice President of Clinical Ophthalmology

2 months ago

California, United States Partnology Full time

A well-capitalized biotechnology firm is in search of an ophthalmologist with substantial experience in clinical development to spearhead strategic initiatives, implementation, and management of their clinical ophthalmology projects. This individual will collaborate closely with the Chief Medical Officer to advance the primary program in Retinitis Pigmentosa and assist in the planning and execution of subsequent initiatives.

Primary Responsibilities:

  • Oversee the formulation of study protocols, execution of studies, and analysis of study outcomes, ensuring the successful delivery of clinical programs.
  • Manage clinical teams composed of professionals from clinical operations, clinical science, biostatistics, regulatory affairs, CMC, pharmacology/toxicology, drug safety, commercial sectors, and partner alliances.
  • Engage with external specialists and advisory panels to obtain valuable insights.
  • Collaborate with central testing facilities to provide guidance on the development of clinical endpoints and other facets of patient assessment.
  • Contribute to the drafting of study protocols, amendments, informed consent forms, investigator brochures, IND applications, annual reports, clinical study reports, and other regulatory documentation, ensuring the accuracy of medical content.
  • Lead and assist in the preparation of clinical research grant proposals.
  • Work alongside the research division to identify and foster new project opportunities in ophthalmology and additional therapeutic fields.
  • Collaborate to assess program risks and devise and implement strategies for mitigation.

Qualifications and Experience:

  • Medical Degree (M.D.) is required.
  • Board certification in ophthalmology is preferred.
  • Experience across various phases of clinical research (Phase 1-3) is advantageous.
  • Familiarity with retinal diseases, imaging techniques, psychophysics, or gene therapy is a plus.
  • A minimum of ten (10) years of clinical research experience within the pharmaceutical or biotechnology sectors is essential.
  • In-depth understanding of clinical regulatory strategies (US FDA, EMA, etc.) and ICH-GCP guidelines is preferred.
  • Proven experience in authoring and presenting clinical research findings is highly desirable.
  • Exceptional written and verbal communication skills are mandatory.
  • Experience in leading interdisciplinary teams is required.