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 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: $399,600 - $427,500 USDLocation: 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.
