Director, Pharmaceutical Development

Salary: $225-250k

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 doesnt 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 $200 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:

We are seeking a Director of Pharmaceutical Development to join our team at SpyGlass Pharma. This role will lead late-stage formulation development activities for our lead program as it advances through Phase 3 clinical development toward submission.

The Director will provide technical and strategic leadership for drug product formulation, scale-up, and CMC development activities required to support late-stage clinical programs and regulatory filings. This individual will work closely with cross-functional teams including analytical development, manufacturing, quality, regulatory affairs, and external development partners to ensure the successful progression of the program toward commercialization.

This role will also lead and mentor a team of scientists and technicians responsible for formulation and process development activities and will play a key role in developing CMC strategies supporting NDA and potential lifecycle management activities including ANDA considerations

Essential Duties & Responsibilities:

• Lead formulation development and CMC activities for late-stage small molecule drug products supporting Phase 3 clinical programs and NDA submission.
• Develop and execute formulation and process development strategies aligned with regulatory expectations for late-stage development and commercialization.
• Serve as a subject matter expert for small molecule drug product formulation, ensuring robust, scalable, and commercially viable formulations.
• Lead and manage a team of scientists and technicians responsible for formulation development and technical studies.
• Design and oversee formulation optimization, stability studies, process characterization, and scale-up activities required for registration.
• Provide strategic leadership for CMC development plans supporting NDA submissions and lifecycle management strategies, including potential ANDA considerations.
• Collaborate closely with cross-functional teams including analytical development, manufacturing, quality assurance, regulatory affairs, and clinical teams to ensure alignment of development activities.
• Author, review, and contribute to CMC sections of regulatory submissions including INDs, NDAs, and related regulatory documentation.
• Manage and oversee activities at Contract Development and Manufacturing Organizations (CDMOs) to ensure timely and high-quality delivery of development and manufacturing milestones.
• Support technology transfer, process validation, and preparation for commercial manufacturing.
• Identify technical risks and develop mitigation strategies to ensure program timelines and regulatory objectives are achieved.
• Provide technical leadership in interactions with regulatory agencies and preparation for regulatory meetings as needed.

Qualifications Required For Position:

• PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline.
• Minimum of 10 years of experience in pharmaceutical development with a focus on small molecule drug product formulation.
• Demonstrated experience leading late-stage pharmaceutical development programs supporting Phase 3 clinical trials and NDA submissions.
• Preference to candidates with ophthalmic drug products or drug delivery systems, or aseptic or sterile pharmaceutical formulations.
• Direct experience contributing to CMC sections of regulatory submissions including NDA and/or ANDA filings.
• Strong expertise in formulation development, scale-up, process development, and technology transfer.
• Experience managing and mentoring scientific teams in pharmaceutical development environments.
• Experience working with CDMOs and external development partners.
• Strong understanding of cGMP requirements and regulatory expectations for late-stage pharmaceutical development.
• Excellent leadership, communication, and collaboration skills with the ability to work effectively in cross-functional teams.
• Ability to operate in a fast-paced, dynamic environment while managing multiple development programs.+

Why SpyGlass Pharma?

• We are offering a range of $225,000 - $250,000, based on experience and qualifications, along with an Annual Bonus opportunity.
• Share in our success with stock options, giving you a stake in the companys 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.