Vice President, Clinical Development Ophthalmology

032628_1717436139
  • USA
  • Permanent

Overview:

We are seeking an accomplished and visionary leader to join a reputable biotechnology company as Vice President, Ophthalmology. This critical role will shape and execute their ophthalmology strategy, leading the clinical and medical aspects of their Phase 3 program as well as the submission, approval, and commercialization processes for their innovative therapies in geographic atrophy. This position requires deep expertise in ophthalmology and drug development, strong leadership skills, and a proven track record of bringing innovative therapies to market.

Key Responsibilities:

  • Drug Development
    • Lead the medical and clinical oversight of the Phase 3 program, including medical monitoring, review and interpretation of clinical data, and communication with sites.
    • Ensure the integrity and quality of abstracts, manuscripts, study reports, regulatory communications and documents, and site or safety communications (in collaboration with pharmacovigilance).
    • Design and implement clinical development strategies and protocols to support the clinical development, registration, and commercialization of our therapies.
    • Represent the program in external engagements with CROs, consultants, and clinical sites.
    • Collaborate with Clinical Operations to oversee the execution of clinical trials, ensuring compliance with regulatory requirements, ethical standards, and timelines, as well as supporting all Medical Monitoring activities.
    • Provide medical leadership for site selection, feasibility, enrollment, issue identification/resolution, and data quality.
    • Support business development activities in ophthalmology.
  • Strategic Leadership
    • Leverage scientific and clinical expertise to guide decision-making and optimize study design and execution.
    • Collaborate with Medical Affairs for KOL engagement, Advisory Committee interactions, and Steering Team meetings.
    • Drive innovation and differentiation through a deep understanding of current and future data generated for the program.
    • Develop and execute robust regulatory strategies in collaboration with Regulatory Affairs and the program team.
    • Interface with regulatory authorities to facilitate successful regulatory submissions and approvals.
    • Stay abreast of evolving regulatory guidelines and requirements pertinent to ophthalmic drug development.
  • Cross-functional Collaboration
    • Foster strong collaboration and alignment across functions, including R&D, clinical development, regulatory affairs, commercial, and other relevant departments.
    • Serve as a key liaison between the ophthalmology team and executive leadership, providing regular updates on portfolio progress and strategic initiatives.
    • Cultivate a culture of teamwork, innovation, and accountability within the ophthalmology organization.

Requirements

  • Advanced degree in life sciences, pharmacy, medicine, or a related field. A Medical Degree with subspecialty training and practice in Ophthalmology or Retina, or an MD or PhD with deep experience in the field of Ophthalmology, is strongly preferred.
  • Minimum of 15 - 20 years of experience in the pharmaceutical or biotechnology industry, with a focus on ophthalmology drug development.
  • Proven track record of leadership in ophthalmology, including successful development and commercialization of ophthalmology products.
  • In-depth understanding of ophthalmic diseases, drug development processes, and regulatory requirements.
  • Demonstrated ability to develop and execute strategic plans, drive innovation, and deliver results in a fast-paced, dynamic environment.
  • Strong leadership and interpersonal skills, with the ability to inspire and influence teams at all levels of the organization.
  • Excellent communication and presentation skills, with the ability to effectively articulate complex scientific and clinical concepts to diverse audiences.
  • Experience interacting with regulatory authorities and leading successful regulatory submissions and approvals.
  • Business acumen and strategic thinking, with a focus on maximizing the commercial potential of ophthalmology products.

Fatlum Topallaj Senior Consultant

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