Associate Director of Pharmaceutical Development

2 days ago

Aliso Viejo, California, United States Spyglass Pharma Full time
Job Title: Associate Director, Pharmaceutical Development

About the Role:

The Associate Director of Pharmaceutical Development will play a key role in leading and managing the development and characterization of small molecule ophthalmic drug delivery implants. This position requires expertise in formulation development, manufacturing processes, regulatory compliance, and team leadership to ensure the successful progression of pharmaceutical development programs.

Key Responsibilities:

  • Manage daily activities supporting the development and characterization of small molecule ophthalmic drug delivery implants.
  • Serve as subject matter expert (SME) for creating robust, phase-appropriate formulations and manufacturing processes ensuring product quality, safety, and efficacy.
  • Lead a team of scientists and engineers in designing, executing, and interpreting development studies for preclinical and clinical stage programs.
  • Collaborate with cross-functional team members including formulation development, process development, engineering, analytical chemistry, regulatory affairs, quality assurance, and manufacturing.
  • Author, review, and approve scientific protocols and reports.
  • Direct activities with Contract Development and Manufacturing Organizations (CDMO) and Contract Research Organizations (CRO) to ensure high-quality and timely outcomes.
  • Establish and provide scientific justification for drug substance, drug product, and raw material specifications.
  • Contribute to the preparation of regulatory documents, including INDs, NDAs, and marketing authorization applications, ensuring compliance with regulatory requirements.
  • Manage project timelines, budgets, and resources to ensure timely and cost-effective delivery of development milestones.
  • Foster a culture of collaboration, creativity, and excellence within the pharmaceutical development team.

Requirements:

  • PhD or equivalent degree in pharmaceutical sciences, chemistry, biochemistry, or related field with a minimum of 8 years of experience in small molecule pharmaceutical development within a pharmaceutical company or CDMO.
  • Bachelor's or equivalent degree in pharmaceutical sciences, chemistry, biochemistry, or related field with a minimum of 12 years of experience in small molecule pharmaceutical development within a pharmaceutical company or CDMO.
  • Demonstrated ability to successfully support late-stage development and registration activities.
  • Expertise in quality by design, quality risk management, and statistical methods related to sustained release dosage form development.
  • Strong leadership and interpersonal skills with the ability to effectively lead and motivate cross-functional teams.
  • Excellent written and verbal communication skills, with the ability to communicate complex scientific concepts to diverse stakeholders.
  • Experience with phase-appropriate regulatory requirements, submissions, and interactions with regulatory agencies (FDA, EMA, etc.).
  • Proficiency in project management tools and software (e.g., MS Project, Smartsheet) is preferred.

About SpyGlass Pharma:

SpyGlass Pharma is a leading company in the development of small molecule ophthalmic drug delivery implants. Our team of experts is dedicated to creating innovative solutions for patients with glaucoma and cataract surgery/intraocular lens replacement. We are committed to actively improving patients' quality of life and strive for paradigm shifts in global eye care.

Equal Opportunity Employer:

SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. We take 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.

Reasonable Accommodation:

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 and let us know the nature of your request and your contact information.

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