Summary:
SpyGlass Pharma is seeking a Vice President of Medical Affairs to lead the medical affairs organization supporting the clinical development, launch readiness, and lifecycle management of a first-in-class sustained drug delivery system in late-stage clinical trials. This position will be responsible for developing and executing the medical affairs strategy, building and leading the field medical organization, advancing KOL engagement and medical education, driving evidence generation plans, and ensuring high-integrity scientific communications that enable a successful launch.
Reporting to the Senior Vice President, Clinical, the Vice President of Medical Affairs will work closely with Clinical Development, Clinical Operations, Commercial / Market Access, Regulatory Affairs, and cross-functional partners to support late-stage clinical development, prepare the organization for launch, and ensure strong alignment across key corporate functions.
Essential Duties & Responsibilities:
- Develop and lead the overall Medical Affairs strategy supporting late-stage clinical development, launch readiness, commercialization, and lifecycle management.
- Build, scale, and lead the Medical Affairs organization, including field medical and medical education capabilities, establishing appropriate objectives, processes, infrastructure, and performance expectations.
- Maintain an active field presence and provide direct oversight and participation in Medical Affairs activities supporting clinical trial execution, including investigator and site engagement, scientific exchange, and trial awareness in close collaboration with Clinical Development and Clinical Operations.
- Lead Medical Affairs launch readiness and execution activities, including medical education, scientific communications, congress strategy, KOL engagement, and evidence generation.
- Develop and maintain strategic scientific relationships with key opinion leaders, investigators, treatment centers, academic institutions, and other external healthcare stakeholders.
- Lead scientific advisory boards, steering committees, investigator meetings, and other external scientific engagements supporting clinical programs and pipeline development.
- Serve as a senior medical and scientific representative for SpyGlass Pharma with key external stakeholders.
- Lead medical education initiatives, including Continuing Medical Education (CME), grants, sponsorships, speaker programs, peer-to-peer education, and scientific and clinical training for field-based teams.
- Lead evidence generation strategy, including real-world evidence programs, post-marketing studies, investigator-initiated research, and other initiatives supporting the clinical and scientific profile of SpyGlass Pharma's programs.
- Oversee scientific communications and publications, including congress abstracts, presentations, manuscripts, and other scientific content.
- Partner with Market Access to support Health Economics and Outcomes Research (HEOR), value dossiers, and scientific exchange with payer and healthcare stakeholders.
- Lead Medical Affairs participation in medical and promotional review processes and provide medical support for regulatory interactions and product labeling activities, as appropriate.
- Ensure Medical Affairs activities are conducted in compliance with applicable regulatory requirements, industry standards, company policies, and requirements governing scientific exchange and medical education.
- Partner with Commercial leadership to align medical and commercial strategies while maintaining scientific integrity and compliance.
- Collaborate with Clinical Development on lifecycle management, potential indication expansion, evidence-generation priorities, and clinical trial planning.
- Partner with Quality, Safety, Regulatory Affairs, and other cross-functional stakeholders to support post-market medical monitoring and pharmacovigilance activities.
- Gather and communicate medical insights, emerging scientific trends, competitive intelligence, and unmet medical needs to inform clinical development and broader organizational strategy.
- Develop and manage Medical Affairs budgets, resource planning, and external partnerships to support departmental and corporate objectives.
Qualifications Required For Position:
- Advanced scientific or clinical degree required (MD, PhD, PharmD, OD, or equivalent).
- Minimum of 15 years of progressive Medical Affairs experience within the pharmaceutical or biotechnology industry, including significant leadership experience.
- Demonstrated experience leading Medical Affairs organizations through late-stage clinical development, pre-launch, launch, and post-launch activities.
- Prior ophthalmology Medical Affairs and product launch experience strongly preferred.
- Experience with sustained drug delivery, drug-device combination products, or related technologies preferred.
- Demonstrated experience building, scaling, and leading field medical and Medical Affairs organizations.
- Strong understanding of late-stage clinical development, clinical trial support, launch readiness, evidence generation, medical education, scientific communications, and lifecycle management.
- Demonstrated success developing and maintaining strategic relationships with KOLs, investigators, academic institutions, and other external scientific stakeholders.
- Experience developing and executing medical education, publication, evidence-generation, and scientific engagement strategies.
- Strong understanding of applicable FDA regulations, industry standards, compliant scientific exchange, medical education, and promotional review requirements.
- Excellent scientific communication and presentation skills, with the ability to translate complex clinical and scientific information for diverse audiences.
- Ability to travel domestically up to 50%.
- Ability to travel internationally, as business needs require.
Why SpyGlass Pharma?
- We are offering a range of $315,000 - $375,000 based on experience and qualifications, along with an Annual Bonus opportunity.
- Share in our success with stock options, giving you a stake in the company's future.
- Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.
- Generous paid time off, including holidays, vacation days, and personal leave.
