Clinical Research Director

3 hours ago

Aliso Viejo, CA, United States Glaukos Corporation Full time
Job Description

How Will You Make an Impact?

As the Clinical Research Director, you will take the helm of cutting-edge clinical studies that push the boundaries of ophthalmic innovation. Your leadership will be crucial in shaping the future of eye care, from the earliest stages of product development through to clinical trials, ensuring that our groundbreaking Glaukos products are safe, effective, and meet stringent regulatory standards. This is more than a role-it's a chance to drive life-changing advancements in ophthalmology that will directly enhance patient outcomes and transform lives. If you're ready to lead the next wave of innovation in eye health, this is your opportunity to make a profound impact.

What Will You Do?
  • Drive Study Execution: Manage all aspects of clinical studies from initiation to closure, including site selection, product management, and communication with study sites. Strong project management skills are essential to tracking milestones and achieving targets.
  • Support Protocol Development: Contribute to the creation of study protocols in compliance with regulatory standards. Your expertise will help ensure protocols align with clinical operations and regulatory requirements, meet the highest industry standards, and contribute to a strong relationship between Glaukos and our investigation partners.
  • Collaborate Cross-Functionally: Partner with Clinical, Regulatory, R&D, and Marketing teams to design and implement successful clinical research programs. Your experience in managing multi-disciplinary projects will drive innovation and seamless integration.
  • Develop Budgets & Contracts: Lead the development of clinical study site budgets, negotiate contracts, and manage vendors. Your ability to manage complex budgets and maintain vendor relationships will ensure smooth study operations.
  • Lead and Develop High-Performing Teams: Build and develop a team of clinical research professionals, fostering a culture of excellence. Prior leadership experience in clinical research is crucial to guide the team and ensure top performance.
  • Drive Enrollment: Proactively identify and address enrollment challenges, using your creative problem-solving skills to ensure enrollment targets are met on time.
  • Ensure Regulatory Compliance: Prepare and submit reports external and internal stakeholders, maintaining a deep understanding of industry regulations to ensure compliance throughout study processes.
  • Contribute to Process Development: Collaborate with Clinical Compliance to refine and develop SOPs and other department processes, leveraging your experience to ensure clinical operations are efficient and effective.
How will you get here?
  • Bachelor's degree required, master's and/or other advanced degree preferred in biological sciences, nursing, or health-related discipline.
  • 12+ years of relevant clinical research experience, preferably in ophthalmology and medical devices, with 9+ years of direct study management.
  • Minimum 4 years of supervisory experience in clinical settings.
  • Combination products or pharmaceuticals necessary to be considered.
  • Experience in ophthalmology and surgical procedures required.
  • Proven leadership in managing multiple clinical trials, including CRA and vendor management, meeting milestones, and managing timelines.
  • Strong skills in study auditing, site monitoring, adverse event reporting, and training CRAs.
  • Expertise in negotiating/executing site and vendor budgets, analyzing study data, and preparing study reports.
  • Experience with study design, protocol writing, and clinical study documentation while successfully problem-solving and cross-functionally collaborating with internal and external stakeholders.
  • Ability to write SOPs and develop processes for improved quality and efficiency, with a willingness to travel as needed.
#GKOSUS

Responsibilities
  • Assists with development and writing of study protocols. Ensures protocols are in compliance with appropriate regulatory requirements and clinical operation written procedures.
  • Responsible for the development of the Clinical Investigator's Brochure (if applicable).
  • Responsible for the development of the study Case Report Forms and associated data collection documents.
  • Responsible for the development of the Informed Consent Form template, ensuring all regulatory requirements are addressed.
  • Responsible for the development of the study Monitoring Plan, patient recruitment materials, and all other study documents.
  • Assists with development of clinical study site budget.
  • Develops training documents for sites, team members, and surgeries. Train team members on clinical study requirements.
  • Assists with project planning, problem resolution, and investigator meetings as needed.
  • Provides proactive leadership in identifying enrollment issues and recommending solutions so that enrollment targets are met.
  • Oversees all aspects of clinical study execution:
    * Manages clinical study product, including inventory projections, requests for shipping (including verification of essential documents), and accountability
    * Assists with site selection
    * Project manages from study initiation through study closure, including timeline development, milestone achievement, and budget projections
    * Oversees site monitoring/management activities of assigned CRAs. Reviews adverse event data, surgical data, and clinical study product accountability and alerts Regulatory Affairs, Clinical management, and Medical Monitor as needed to ensure UADEs and potential product issues are properly reported
    * Communicates with sites, including leading enrollment teleconferences, organizing investigator meetings, and traveling to sites as needed
    * Negotiates budgets with sites, assists with site contract execution, and administers grant payments.
    * Assists with ClinicalTrials.gov as needed
    * Assists with selection of vendors
  • Assists with development of budgets and contracts with vendors
  • Manages vendors to ensure proper study execution
  • Communicates with vendors as main study contact
  • Assists with development of clinical study reports (communications/reports to regulatory bodies, DSMB meetings, interim and final reports)
  • Participates in the preparation of regulatory submissions as needed.
  • Submits reports to IRBs as required.
  • Develops and provides progress reports to management as needed.
  • Assists with investigator meetings at glaucoma-related conferences as needed.
  • Responsible for process development within the clinical department in order to ensure quality, effective, and efficient clinical operations:
    * Writes SOPs and associated documents or reviews documents written by other department employees
    * Develops processes to assess compliance with SOPs and study processes, including metrics
  • Hires, trains, and supervises employees/contractors in order to ensure quality, effectiveness and productivity.
  • Assigns projects with clear milestones and monitors progress to ensure timely completion.
  • Provides supervisor of assigned team members with feedback on performance and assists with development through assigned study tasks.
  • Assists employees with developmental needs and provides development opportunities
  • Develops relationships with key opinion leaders and clinical investigators.
  • Stays abreast of recent developments in ophthalmology and attends ophthalmic congresses on a periodic basis.


Qualifications

- Bachelor's Degree in biological science, nursing, or other health-related discipline preferred. Preferred

- Advanced degree, M.D., O.D Preferred

- PhD Preferred

- 12+ years relevant work experience in the clinical research industry, preferably with experience in ophthalmology and medical devices. Required

- At least 7 years with direct study management experience. Required

- 4 years of experience with supervision of clinical employees Required

- Excellent project leadership skills and able to manage multiple clinical trials, including CRA and vendor management, and ability to meet milestones and manage timelines Required

- Study auditing and site monitoring skills and ability to train CRAs Required

- Experience with negotiating and executing site and vendor budgets Required

- Experience with adverse event reporting and documentation Required

- Able to analyze and summarize study data, and assist with writing study reports Required

- Able to assist with study design and writing of protocols and all associated study documents Required

- Knowledge of clinical study product management and requirements for verifying accountability Required

- Excellent problem solving skills Required

- Excellent written and verbal communication skills Required

- Self-motivated and able to work independently, as well as within a team Excellent organizational skills Required

- Experience with writing SOPs and process development/improvement to increase quality and efficiencies Required

- Must be willing and able to travel approximately 20% Required

- Medical and ophthalmology terminology helpful Required

- Exhibits personal integrity, credibility, and responsibility Required

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