Associate Director, Pharmaceutical Development

Job Description

Job Description

Salary : $150k - $175k

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 :

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.

Essential Duties & 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.

Qualifications Required For Position :

• 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 lates 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.

Why SpyGlass Pharma?

• We are offering a range of $150,000 - $175,000, 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.