Vice President, Clinical Development-Ophthalmology

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 Huntingtons 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 youll 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.

Were seekingexceptional talent from all backgrounds to fuel our growth. At Annexon were building a diverse equitable and inclusive workplace. We value unique perspectives and unconventional paths. If youre the best candidate for the job even if you dont perfectly fit the traditional mold we encourage you to more about our commitment to diversity equity inclusion and our companyculture!

Position:

We are seeking an accomplished and visionary leader to join our team as Vice President Clinical Development-Ophthalmology. The Vice President Clinical Development-Ophthalmologywill play a critical role in shaping and executing our ophthalmology strategy serve as the clinical leader for Annexons 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 ClinicalDevelopment-Ophthalmologywill 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-Ophthalmologyincumbent 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 CROs 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 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.

Education Experience and Skills:

Required:

• 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.

Preferred:

• 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.

Salary Range: $399600 $427500 USD

Location:Annexon Biosciences is located in Brisbane California and preference is given to candidates in the San Francisco Bay Area.

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.

Annexon Biosciences is an Equal Opportunity Employer and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths views and experiences. We believe that our differences enable us to be a better team one that makes better decisions drives innovation and delivers better business results. Creativity and innovation flourish in an environment of openness inclusion and mutual respect.