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Senior Manager, Clinical Development

Senior Manager, Clinical Development

Spyglass PharmaAliso Viejo, CA, US
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Job Description

Job Description

Salary : $160-180k

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 :

SpyGlass Pharma is seeking a Senior Manager of Clinical Development to support the execution of clinical development activities for our lead program and broader R&D pipeline. This individual will contribute to the planning, implementation, and oversight of pre-clinical and clinical research efforts aligned with product development plans. As a key member of the R&D team, this person will collaborate closely with internal colleagues and external partners to ensure that clinical activities meet regulatory and scientific standards. The ideal candidate will bring relevant experience in ophthalmology or drug-device combination product development and a solid background supporting clinical trial operations and regulatory submissions.

Essential Duties & Responsibilities :

Clinical Development

  • Contribute to the development and implementation of target product profiles and clinical development plans.
  • Support internal R&D team members in the planning and execution of pre-clinical and clinical activities across the pipeline.
  • Assist with the evaluation of new product opportunities and business development activities.

Clinical Trials Management

  • Draft, review, and support preparation of clinical trial synopses, protocols, Investigator Brochures, and Clinical Study Reports.
  • Coordinate with Clinical Operations, CROs, and vendors to support trial planning, execution, and reporting.
  • Contribute to the review of safety plans, medical monitoring plans, and protocol deviation plans.
  • Participate in review of SAPs, TLF shells, and assist in data interpretation and reporting.
  • Support literature reviews, meta-analyses, and manuscript development.
  • Contribute to preparation of regulatory documents (e.g., IND / NDA sections).
  • Assist with clinical study entries for registries and support responses to health authority queries.
  • Clinical Study Publication

  • Support the drafting and review of abstracts, posters, and manuscripts.
  • Collaborate with Medical Affairs and Clinical Operations on research dissemination.
  • Qualifications Required For Position :

  • Bachelors degree in the sciences required; advanced degree (PhD, PharmD) preferred but not required.
  • 8 years of pharmaceutical or biotech clinical research experience, including involvement in preclinical and Phase IIII studies.
  • Experience supporting study design, trial execution, data interpretation, and scientific publication.
  • Background in ophthalmology or drug-device combination products strongly preferred.
  • Familiarity with regulatory compliance, IND / NDA submissions, and FDA / ICH / GCP standards.
  • Strong cross-functional collaboration and communication skills.
  • Demonstrated ability to provide reliable clinical development support in a fast-paced, growth-stage environment.
  • Why SpyGlass Pharma?

  • We are offering a range of $160,000 - $180,000, 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.

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    Senior Manager Development • Aliso Viejo, CA, US

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