Vice President, Clinical Development-Ophthalmology

Responsibilities

• Lead the medical/clinical oversight of the Phase 3 program including: communication with sites throughout the study in collaboration with the Medical Affairs team, review and interpretation of all clinical data, and communication of results in scientific and informal venues
• Medical authorship and ensuring the integrity and quality of abstracts, manuscripts, study reports, and regulatory communications and documents, and site or safety (in collaboration with pharmacovigilance) communications
• Serve as the clinical expert developing the life cycle management plan for vonaprument including an open-label extension study, subset identification, extended dosing, and expanded indications; lead in the preparation of phase 4 clinical studies for these objectives
• Interact with Key Opinion Leaders to educate and advance the field on the benefit afforded by vonaprument based on its unique mechanism of action
• Identify core objectives for the design and implementation of the clinical development strategy including an open label extension and, in collaboration with Medical Affairs, Phase 4 clinical studies that support the development, registration, and commercialization of vonaprument
• Represent Annexon and the vonaprument program for external engagements with CRO’s, consultants, sites, etc. In collaboration with Clinical Operations, oversee the execution of clinical trials, ensuring compliance with regulatory requirements, ethical standards, and timelines as well as support for Medical Monitoring activities
• Provide the primary authorship for key clinical sections of marketing authorization submissions (e.g., BLA, MAA, etc.). Provide medical leadership for issue identification/resolution, and data quality
• Support for business development activities in Ophthalmology
• Strategic Leadership: Serve as a member of the vonaprument Core Team and Development Leadership Team to support the creation and execution of a strategic plan for vonaprument, in collaboration with team members, the Program Team Leader, and functional leadership
• Leverage scientific and clinical expertise to guide decision-making and optimize execution and data interpretation
• Drive innovation and differentiation of vonaprument through the deep and complete understanding of current and future data generated for the program
• In collaboration with Regulatory Affairs and vonaprument Program team, develop and execute robust regulatory strategies for the program
• Interface with regulatory authorities to facilitate successful regulatory submissions and approvals
• Stay abreast of evolving guidelines and requirements for ophthalmic drug development

Qualifications

• Medical Degree with subspecialty training and practice in Retina and MD or MD/PhD with deep experience in the field of Ophthalmology required
• 15 – 20 + years of experience in the pharmaceutical or biotechnology industry, with a focus on ophthalmology drug development
• Prior experience as a VP in Clinical Development strongly preferred
• 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