Director, Clinical Affairs

2 weeks ago

Aliso Viejo, United States Spyglass Pharma Full time
Job DescriptionJob DescriptionSalary: $175k - $215k

About SpyGlass Pharma:


At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care.

 

Our team comprises professionals with diverse expertise in ophthalmic devices and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology, IOL development, and commercial success. Led by a proven team with expertise in science, R&D, communications, and operations, SpyGlass Pharma™ takes ideas from inception through commercialization.


Our commitment to actively improving patients’ quality of life drives the company to innovate and succeed.

Learn more at www.spyglasspharma.com 


Summary:


We are seeking an experienced Director of Clinical Affairs to join our team at SpyGlass Pharma. The Clinical Director is responsible for the leadership and the results of the clinical team throughout the Global Clinical Development process. This position has the responsibility for supporting the VP, Clinical Operations in developing and implementing global clinical strategy. This includes responsibility for the clinical team’s creation of relevant documents and outputs including Clinical Development Plan (CDP), clinical program feasibility, Investigator brochures, study protocol synopsis, clinical study protocols, top line study data, Clinical Study Report (CSR), clinical sections of regulatory documents including the clinical sections of the CTD for regulatory submissions, and planning of the Annual reports together with Regulatory affairs and respective clinical team members. This position ensures alignment of the CDP with the Global Development Plan (GDP). In addition, the Clinical Director oversees achievement of all activities related to the Clinical development program, including achievement of key program milestones within the planned time lines and budget. The position interacts with all levels in the organization, participating in discussions with management and providing strategic clinical guidance.

 

Essential Duties & Responsibilities:


  • Support the Clinical Affairs team to develop and implement global clinical strategies.
  • Supervise and manage the clinical staff responsible for planning overall clinical study operations that meet the strategic objectives defined by the project team
  • Work with clinical team to execute global clinical strategies, programs, and protocols.
  • Provide strategic clinical guidance to interdisciplinary project teams, aligning with FDA/Regulatory Agency requirements, FDA/ICH guidelines, IRB/IEC requirements, Good Clinical Practices (GCP), and industry best practices.
  • Proactively identify clinical issues and recommend / implement solutions to resolve them.
  • Participate in FDA, Regulatory Agency, IRB/IEC meetings as needed.
  • Prepare and 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.
  • Manage and 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, to ensure regulatory compliance and successful product development.
  • 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).
  • Stay abreast of clinical trends, changes, and requirements in the pharmaceutical industry, providing strategic guidance and recommendations to senior management on regulatory matters.

 

Qualifications Required For Position:


  • Bachelor's degree preferred.
  • Minimum of 12 years of experience in clinical affairs within the pharmaceutical or medical device industry, with a preference on drug and drug/device combination products.
  • Minimum of 3 years of experience as a team leader of a cross-functional development team/subteam in a clinical development organization
  • Thorough understanding of GCP and industry best practices with clinical trial management, monitoring, regulatory compliance, data management and statistical reporting.
  • Experience in US, EU, and international 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.
  • Experience in preparing US IND/amendments, annual reports, and briefing books.
  • Experience in preparing the annual budget forecast and monitor expenditures.
  • Thorough understanding of the CFR, FDA/ICH guidelines, GxP and cGMP as they pertain to pharmaceutical development and manufacturing.
  • Proven track record of successful clinical studies, meetings, enrollment, and interactions with regulatory agencies.
  • Strong leadership, communication, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
  • Experience in clinical strategy development, investigational product supply, regulatory compliance, and leading 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.


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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