Clinical Trial Associate

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 $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:

We are seeking a Clinical Trial Associate (CTA) /
Senior CTA to join our team at SpyGlass Pharma. The CTA is responsible for executing the tasks on the clinical team throughout the clinical trial. This position has the responsibility for supporting the Sr. Director Clinical Affairs in executing and implementing global clinical decisions. This includes responsibility for the clinical teams creation of relevant documents and outputs including feasibility questionnaires regulatory documents enrollment reports data listings and patient summaries. The CTA will review the investigator brochures study protocol synopsis clinical study protocols top line study data Clinical Study Report (CSR) clinical sections of regulatory documents and the Annual reports. This position executes implements and manages various tasks to assist in the achievement of all activities related to the Clinical development program including achievement of key program milestones within the planned timelines and budget. The position may interact with multiple levels in the organization participating in discussions with management and providing clinical updates.

Essential Duties and Responsibilities:

• Support the Clinical Affairs team to execute tasks throughout the clinical trials.
• Manage and execute the tasks for the strategic objectives defined by the project team
  
• Work with clinical team
  to execute global clinical strategies programs and protocols.
  
• Provide clinical support to interdisciplinary project teams aligning with FDA/Regulatory Agency requirements FDA/ICH guidelines IRB/IEC requirements Good Clinical Practices (GCP) and industry best practices.
• Be aware of clinical issues and help to resolve them.
• Participate in FDA Regulatory Agency IRB/IEC meetings as needed.
• Review of regulatory submissions including clinical trial applications IND IDE NDA PMA annual reports CIB updates meeting packages technical files/design dossier for FDA and other regulatory agencies as needed.
• Facilitate regulatory document collection and follow-up with team members ensuring that all documents and tasks are in accordance with predetermined timelines.
• Work in a dynamic matrixed environment by collaborating closely with cross-functional teams including R&D Regulatory Affairs Quality Assurance and project management teams while following GCP and industry best practices.
• Interact and coordinate with R&D staff (CMC and Engineering) vendors and consultants to ensure compliance to applicable Design Control and pharmaceutical requirements (for drug/device combination products).
• Learn about clinical trends changes and requirements in the pharmaceutical industry providing recommendations to senior management on regulatory matters.
  

Qualifications Required for Position:

• Bachelors degree in life sciences healthcare biomedical engineering or a related field preferred.
  
• 2 years for CTA 4 years for Sr CTA 6 years for Sr CTA2 or 8 years for Principal CTA of experience in clinical affairs within the pharmaceutical or medical device industry with a preference on drug and drug/device combination products. (A commensurate combination of education and experience will be considered.)
  
• Some experience in a cross-functional development team/subteam in a clinical development organization
  
• Knowledge of GCP and industry best practices with clinical trial management monitoring regulatory compliance data management and statistical reporting.
  
• Knowledge of US clinical and regulatory requirements and guidelines for drug and drug/device combination products including FDA/Regulatory Agency requirements FDA/ICH guidelines and IRB/IEC requirements.
  
• Awareness of preparing US IND/amendments annual reports and briefing books.
  
• Awareness of preparing the annual budget forecast and monitor expenditures.
  
• Knowledge of the CFR FDA/ICH guidelines GxP and cGMP as they pertain to pharmaceutical development and manufacturing.
  
• Previous experience conducting clinical studies meetings enrollment and interactions with regulatory agencies.
  
• Willingness to learn leadership communication and interpersonal skills with the ability to collaborate effectively with cross-functional teams and external partners.
  
• Awareness of clinical strategy development investigational product supply regulatory compliance and clinical activities for clinical trials of all phases.
  
• Ability to work in a fast-paced dynamic environment and manage multiple projects simultaneously while maintaining attention to detail and quality.
  

Why SpyGlass Pharma

• We are offering a range of $90000 - $110000 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 and let us know the nature of your request and your contact information.

Required Experience:

Senior IC