What are the responsibilities and job description for the Clinical Application Specialist, Manager position at Spyglass Pharma?
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 Manager, Clinical Application Specialist will oversee the execution of clinical applications and training programs to support the adoption and success of SpyGlass Pharma's ophthalmic drug delivery systems. This role involves managing a team of Clinical Application Specialists and ensuring that educational initiatives and clinical support meet the highest standards. The position requires collaboration with clinical sites, healthcare professionals, and internal stakeholders to drive patient and clinical outcomes while maintaining compliance with all regulatory and company standards..
Essential Duties and Responsibilities:
- Lead, mentor, and manage a team of Clinical Application Specialists to provide training and clinical support at investigative sites.
- Develop and implement clinical application strategies to ensure successful deployment of SpyGlass Pharma’s products in clinical and commercial settings.
- Collaborate with the Clinical Affairs team to provide feedback and insights from clinical sites, contributing to the development and refinement of protocols and products.
- Coordinate training programs for healthcare providers, ensuring proper understanding and application of product usage.
- Maintain regular communication with clinical investigators and site staff to provide ongoing support and address challenges.
- Track and evaluate the effectiveness of training and support activities, implementing improvements as necessary.
- Ensure adherence to all FDA regulations, GCP guidelines, and company SOPs.
- Represent SpyGlass Pharma at key industry meetings, conferences, and site visits.
- Manage documentation and reporting for training and support activities to ensure consistency and compliance.
- Support cross-functional teams, including Clinical Operations, Regulatory Affairs, and Quality Assurance, in achieving clinical objectives.
Qualifications Required for Position:
- Bachelor’s degree in life sciences, healthcare, or a related field; advanced degree preferred.
- 10 years of experience in clinical applications or related roles within the pharmaceutical or medical device industry. (A commensurate combination of education and experience will be considered.)
- Proven experience managing a team in a clinical or technical support capacity.
- Strong knowledge of GCP, FDA regulations, and clinical trial protocols.
- Exceptional communication, training, and presentation skills.
- Ability to work collaboratively with cross-functional teams and external partners.
- Willingness to travel up to 30-50% domestically to support clinical sites and training programs.
- Proficiency in Microsoft Office Suite and clinical data management systems.
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.
Salary : $150