Vice President, Ophthalmology – Clinical Development

Annexon Biosciences•Brisbane, CA

16h•Onsite

About The 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.

Requirements

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.

Nice To Haves

Experience with regulatory submissions and clinical trial oversight in a biotech or pharmaceutical setting.
Familiarity with emerging trends in ophthalmology, including cutting-edge therapeutic modalities.

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
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
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
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.

Benefits

A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
Shuttle service from BART, CalTrain and the Ferry.
Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.

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