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 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.
