- Lead the medical/clinical oversight of the Phase 3 program including: medical monitoring, review and interpretation of clinical data, and communication with sites
- 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
- Identify core objectives that lead to the design and implementation of the clinical development strategy and protocols to support the clinical development, registration, and commercialization of ANX007
- Represent Annexon and ANX007 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 all 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 biostatistics
- Provide medical leadership for site selection, feasibility, enrollment, issue identification/resolution, and data quality
- Support for business development activities in Ophthalmology
Strategic Leadership: - Serve as a member of the ANX007 Core Team and Development Leadership Team to support the creation and execution of a strategic plan for ANX007, in collaboration with team members, the Program Team Leader, and functional leadership
- Leverage scientific and clinical expertise to guide decision-making and optimize study design and execution
- Leadership role in collaboration with Medical Affairs for KOL engagement, Advisory Committee interactions, and Steering Team meetings
- Drive innovation and differentiation of ANX007 through the deep and complete understanding of current and future data generated for the program
- In collaboration with Regulatory Affairs and ANX007 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 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 related field. Medical Degree with subspecialty training and practice in Ophthalmology, Retina or and MD or PhD with deep experience in the field of Ophthalmology 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.
What Annexon offers - Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. We continuously work to build our pipeline of underrepresented candidates for our workforce, enhance, recruit and develop a best-in-class, diverse, equitable and inclusive workforce; ensure that Black, LatinX and other underrepresented candidates have long-term sustainable opportunities to work with Annexon; and hold our vendors to the same standards under which we operate. To learn more about Annexon's diversity commitment, culture and values, please visit
- A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
- We are located in Brisbane, CA, with 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, as well as other benefits.
Company SummaryAnnexon Biosciences is a clinical-stage biopharmaceutical company seeking to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical data anticipated throughout 2023 and beyond.
EEO Employer – Annexon highly values Diversity, Equity, Inclusion and Belonging
Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.
Staffing Agencies
Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences. Please do not send agency CVs/resumes through Annexon's website or Annexon Employees. Inquiries must be sent to with the Subject Heading: Staffing Agency Request.
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Vice President, Ophthalmology – Clinical Development - South San Francisco, United States - Annexon, Inc.
Description
Work Location
Corporate Headquarters (South San Francisco, CA) Onsite – Hybrid
Non-local candidates will be considered
Position Summary
We are seeking an accomplished and visionary leader to join our team as Vice President, Ophthalmology. The Vice President, Ophthalmology will play a critical role in shaping and executing our ophthalmology strategy, serving as part of the ANX007 Core Team, leading the clinical/medical aspects of the Phase 3 program as well as the medical components of the submission, approval, and commercialization of ANX007 for the treatment of geographic atrophy. This role requires a seasoned professional with deep expertise in ophthalmology 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, Ophthalmology will be responsible for driving the clinical strategic direction of our ANX007 franchise working collaboratively with key team leadership. Like all Annexon leaders, the VP, Ophthalmology – Clinical Development 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.
Key Responsibilities
Drug Development:
