Vice President, Clinical Development-Ophthalmology
Annexon Biosciences
6 months ago
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Vice President, Clinical Development – Ophthalmology
Responsibilities:
- Lead medical/clinical oversight of the Phase 3 program (site communications with Medical Affairs, review/interpret clinical data, communicate results).
- Medical authorship: ensure integrity/quality of abstracts, manuscripts, study reports, and regulatory communications; support site/safety communications with pharmacovigilance.
- Develop life cycle management plan for vonaprument (open-label extension, subset identification, extended dosing, expanded indications); lead preparation of Phase 4 studies.
- Engage Key Opinion Leaders to educate and advance the field on vonaprument’s benefits.
- Define objectives and implement clinical development strategy (open-label extension and, with Medical Affairs, Phase 4 studies supporting development, registration, and commercialization).
- Represent Annexon and vonaprument in external engagements (CROs, consultants, sites, etc.).
- Oversee clinical trial execution with Clinical Operations to ensure regulatory/ethical compliance, timelines, and Medical Monitoring support.
- Serve as Ophthalmology Lead for the development team (partnering with Program Team Leader, development operations, clinical operations, pharmacovigilance, clinical quality, biometrics).
- Provide primary authorship for key clinical sections of marketing authorization submissions (e.g., BLA/MAA).
- Provide medical leadership for issue identification/resolution and data quality.
- Support ophthalmology business development activities.
Strategic Leadership:
- Member of vonaprument Core Team/Development Leadership Team to create and execute the program strategy.
- Use scientific/clinical expertise to guide decisions, optimize execution, and interpret data.
- Lead with Medical Affairs on KOL engagement, Advisory Committee interactions, and Steering Team meetings.
- Drive innovation/differentiation through deep understanding of current/future program data.
- With Regulatory Affairs, develop and execute regulatory strategies; interface with regulatory authorities.
- Stay current on ophthalmic drug development guidelines/requirements.
Cross-Functional Collaboration:
- Align across R&D, clinical development, regulatory affairs, commercial, and other departments.
- Liaison between ophthalmology team and executive leadership with regular portfolio/initiative updates.
- Cultivate teamwork, innovation, and accountability in the ophthalmology organization.
Required:
- Medical Degree with subspecialty training and practice in Retina and MD, or MD/PhD with deep ophthalmology experience.
- 15–20+ years in pharma/biotech with focus on ophthalmology drug development.
- Prior VP experience in Clinical Development (strongly preferred).
- Proven leadership in ophthalmology, including development and commercialization of ophthalmology products.
- Deep understanding of ophthalmic diseases, drug development, and regulatory requirements.
- Demonstrated ability to develop/execute strategic plans and deliver results in a fast-paced environment.
- Strong leadership/interpersonal skills; ability to inspire and influence.
- Excellent communication/presentation skills.
- Experience interacting with regulatory authorities; led successful submissions/approvals.
- Business acumen and strategic thinking to maximize commercial potential.
Preferred:
- Experience with regulatory submissions and clinical trial oversight in pharma/biotech.
- Familiarity with emerging ophthalmology trends and therapeutic modalities.
Benefits:
- Flexible work schedules, remote opportunities, and work-life balance.
- Shuttle service from BART, CalTrain, and the Ferry.
- Competitive base salary and equity participation; employee stock purchase plan.
- Comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans, and other benefits).
Responsibilities:
- Lead medical/clinical oversight of the Phase 3 program (site communications with Medical Affairs, review/interpret clinical data, communicate results).
- Medical authorship: ensure integrity/quality of abstracts, manuscripts, study reports, and regulatory communications; support site/safety communications with pharmacovigilance.
- Develop life cycle management plan for vonaprument (open-label extension, subset identification, extended dosing, expanded indications); lead preparation of Phase 4 studies.
- Engage Key Opinion Leaders to educate and advance the field on vonaprument’s benefits.
- Define objectives and implement clinical development strategy (open-label extension and, with Medical Affairs, Phase 4 studies supporting development, registration, and commercialization).
- Represent Annexon and vonaprument in external engagements (CROs, consultants, sites, etc.).
- Oversee clinical trial execution with Clinical Operations to ensure regulatory/ethical compliance, timelines, and Medical Monitoring support.
- Serve as Ophthalmology Lead for the development team (partnering with Program Team Leader, development operations, clinical operations, pharmacovigilance, clinical quality, biometrics).
- Provide primary authorship for key clinical sections of marketing authorization submissions (e.g., BLA/MAA).
- Provide medical leadership for issue identification/resolution and data quality.
- Support ophthalmology business development activities.
Strategic Leadership:
- Member of vonaprument Core Team/Development Leadership Team to create and execute the program strategy.
- Use scientific/clinical expertise to guide decisions, optimize execution, and interpret data.
- Lead with Medical Affairs on KOL engagement, Advisory Committee interactions, and Steering Team meetings.
- Drive innovation/differentiation through deep understanding of current/future program data.
- With Regulatory Affairs, develop and execute regulatory strategies; interface with regulatory authorities.
- Stay current on ophthalmic drug development guidelines/requirements.
Cross-Functional Collaboration:
- Align across R&D, clinical development, regulatory affairs, commercial, and other departments.
- Liaison between ophthalmology team and executive leadership with regular portfolio/initiative updates.
- Cultivate teamwork, innovation, and accountability in the ophthalmology organization.
Required:
- Medical Degree with subspecialty training and practice in Retina and MD, or MD/PhD with deep ophthalmology experience.
- 15–20+ years in pharma/biotech with focus on ophthalmology drug development.
- Prior VP experience in Clinical Development (strongly preferred).
- Proven leadership in ophthalmology, including development and commercialization of ophthalmology products.
- Deep understanding of ophthalmic diseases, drug development, and regulatory requirements.
- Demonstrated ability to develop/execute strategic plans and deliver results in a fast-paced environment.
- Strong leadership/interpersonal skills; ability to inspire and influence.
- Excellent communication/presentation skills.
- Experience interacting with regulatory authorities; led successful submissions/approvals.
- Business acumen and strategic thinking to maximize commercial potential.
Preferred:
- Experience with regulatory submissions and clinical trial oversight in pharma/biotech.
- Familiarity with emerging ophthalmology trends and therapeutic modalities.
Benefits:
- Flexible work schedules, remote opportunities, and work-life balance.
- Shuttle service from BART, CalTrain, and the Ferry.
- Competitive base salary and equity participation; employee stock purchase plan.
- Comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans, and other benefits).