Vice President, Clinical Development-Ophthalmology

About this role

Company:

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline . We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture !

Position:

We are seeking an accomplished and visionary leader to join our team as Vice President, Clinical Development-Ophthalmology. The Vice President, Clinical Development-Ophthalmology will play a critical role in shaping and executing our ophthalmology strategy, serve as the clinical leader for Annexon’s ophthalmology portfolio, including late-stage programs such as Vonaprument including data readout, interpretation, communication, submission, approval, and commercialization of vonaprument for the treatment of geographic atrophy. This role requires a seasoned professional with deep expertise in ophthalmology, particularly in retinal diseases, and drug development within this therapeutic area, possessing strong leadership skills, and a track record of success in bringing innovative therapies to market. The Vice President, Clinical Development-Ophthalmology will be responsible for driving the clinical strategic direction of our vonaprument franchise working collaboratively with key team leadership. Like all Annexon leaders, the Vice President, Clinical Development-Ophthalmology incumbent will have a deep-rooted commitment to serving patients and a passion for transforming the lives of people with serious diseases and their families.

Responsibilities include:

Drug Development:

• 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

• Interactions with Key Opinion Leaders to education 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

• Serve as the Ophthalmology Lead for the development team, partnering closely with the Program Team Leader, heads of development operations, clinical operations, pharmacovigilance, clinical quality, and biometrics

• 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

• Leadership role in collaboration with Medical Affairs for KOL engagement, Advisory Committee interactions, and Steering Team meetings

• 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

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 k

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