About SpyGlass Pharma:

At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.

We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, “We create for patients” doesn’t just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen.

This team has delivered a solid foundation of development and clinical data, enabling over $120 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.

Summary:

SpyGlass Pharma is seeking a Senior Director / VP of Clinical Development to serve as the clinical and medical strategic lead for our lead program and the broader R&D pipeline as the company advances its portfolio. This individual will be accountable for clinical strategy development, implementation, and oversight of all pre-clinical and clinical research efforts aligned with product development plans. As an integral member of the R&D leadership team, this individual will work closely with the Head of Clinical Operations, internal teams and external partners to ensure that clinical activities meet regulatory and scientific standards. The ideal candidate will bring deep experience in ophthalmology and drug-device combination product development and a proven track record in delivering late-stage clinical programs.

Essential Duties and Responsibilities:

Clinical Development

• Lead the generation and implementation of the target product profile and clinical development plan for the lead program.
• Steer internal R&D team members for the planning and execution of pre-clinical and clinical activities of the R&D pipeline.
• Serve as clinical lead in evaluating new product opportunities and BD activities

Clinical Trials Management

• Prepare, review, and approve clinical trial synopses, protocols, Investigator Brochures, and Clinical Study Reports.
• Support the planning, implementation, management, and reporting of clinical trials.
• Review and approve Medical Monitoring Plans, Safety Plans, and Protocol Deviation Plans.
• Review SAPs and TLF shells; oversee data interpretation and data mining.
• Guide literature reviews, meta-analyses, and manuscript development.
• Contribute to the preparation of regulatory documents (IND/NDA medical sections).
• Collaborate with internal teams and CROs for study execution and issue resolution.
• Partner with Regulatory on clinical responses to health authority queries.
• Review and approve clinical study entries for posting to clinical trial registries.

Clinical Study Publication

• Lead the development, review, and approval of abstracts, posters, and manuscripts.
• Support Medical Affairs and Clinical Operations with oversight on collaborative research.

Qualifications Required for Position:

• Bachelor's degree in the sciences; advanced scientific degree (PhD, PharmD) preferred.
• Minimum of 15 years of directly related pharmaceutical clinical research experience, including preclinical, Phase I–IV studies and regulatory submissions (IND/NDA).
• Demonstrated expertise in study design, trial execution, clinical database maintenance, data interpretation, hypothesis generation, and scientific publication.
• Deep experience in ophthalmology with a proven track record in delivering late-stage clinical programs
• Experience in regulatory compliance and strategic input into cross-functional R&D efforts.

Why SpyGlass Pharma?

• We are offering a range of $250,000 - $300,000, 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.

SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to JOBS@SPYGLASSPHARMA.COM and let us know the nature of your request and your contact information.