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Senior Vice President of Clinical Ophthalmology

2 months ago

California, United States Partnology Full time

Partnology, a leading biotech firm, is on the lookout for a seasoned ophthalmologist with a robust background in clinical development to spearhead strategic initiatives, execution, and oversight of clinical programs focused on ophthalmology. This role involves close collaboration with the Chief Medical Officer to advance the primary program targeting Retinitis Pigmentosa and to strategize subsequent initiatives.

Key Responsibilities:

  • Lead the formulation of study protocols, oversee study execution, and ensure successful clinical program implementation.
  • Manage clinical teams across various domains including clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharmacology/toxicology, drug safety, commercial sectors, and partnership alliances.
  • Engage with external specialists and advisory panels to gather insights and recommendations.
  • Collaborate with central testing facilities to provide expert input on clinical endpoint development and patient evaluation processes.
  • Contribute to the drafting of study protocols, amendments, informed consent forms, investigator brochures, IND submissions, annual reports, clinical study reports, and other regulatory documents, ensuring the medical accuracy of all content.
  • Lead and support the preparation of clinical research grant applications.
  • Work in conjunction with the research division to identify and nurture new project opportunities within ophthalmology and related therapeutic fields.
  • Identify potential program risks and develop and implement effective mitigation strategies.

Desired Skills and Experience:

  • Medical Degree (M.D.) is required.
  • Board certification in ophthalmology is highly desirable.
  • Experience across multiple phases of clinical research (Phase 1-3) is preferred.
  • Familiarity with retinal diseases, imaging techniques, psychophysics, or gene therapy is advantageous.
  • A minimum of ten (10) years of clinical research experience within the pharmaceutical or biotech 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 strongly preferred.
  • Exceptional written and verbal communication skills are mandatory.
  • Experience in leading cross-functional teams is required.