Location: United States - Redwood City
Function: Clinical Operations
The Associate Director (AD), Clinical Operations reports to the Head of US Clinical Operations. The AD is primarily responsible for the management of clinical programs sponsored by Relypsa or its parent company, Vifor Pharma and for the selection and oversight of clinical service providers. The AD is also responsible for the management and mentoring of direct reports. In addition, the AD supports departmental and corporate initiatives in collaboration with Relypsa and/or Vifor Pharma leadership.
• Lead and manage the execution of clinical programs. Collaborate with the Medical Monitor and Clinical Study Team to ensure that the study meets its milestones within the established timeline and budget, consistent with regulatory requirements, the approved clinical plan and corporate goals.
• Work seamlessly with other functions to support their deliverables for clinical programs. Represents Clinical Operations in project team meetings and collaborate with other functional groups within the company (Clinical Development, Drug Safety and Pharmacovigilance, Biometrics, Clinical Research Compliance, Regulatory, QA, Pharmaceutical Operations, Legal, Medical Affairs, etc.) to achieve clinical study goals and timelines.
• Implements training programs for team members on clinical programs.
• Select and manage clinical study service providers, including Clinical Research Organizations, Central Laboratory, Central Imaging, and Interactive Response Technology (IRT). Work closely with the Finance department to ensure adequate reporting of quarterly invoices and accruals.
• Collaborate with the Medical Monitor, Biometrics and Data Management on the review and reporting of the study’s data per the approved Statistical Analysis Plan and Study Protocol.
• In collaboration with the Medical Monitor, Medical Writer and other scientific contributors, oversee the writing of study protocols and final study reports.
• Partner with Clinical Operations management on infrastructure development, including creation of Standard Operating Procedures; Clinical Operations Development and Training Plans; annual budgeting process.
• Ensures consistency with clinical operations best practices across all locations of Vifor Pharma and its affiliated groups.
• Collaborate with internal stakeholders on maintaining key partnerships with foundations and patient advocacy groups in support of clinical programs.
• Manage, develop, and support direct reports (co-located or remote) through regular coaching and mentoring sessions as well as providing guidance to direct reports on individual career paths.
• Perform site visits with direct reports to assess performance, as needed.
• Review deliverables from direct reports to assess quality or work.
• Establish metrics to further evaluate the effectiveness of each role
• Manage and support contingency workers, as needed.
• Comply with GCP/ICH guidelines, local regulatory requirements and Vifor Pharma and applicable Relypsa SOPs.
• Candidate must have a BS or higher degree in science, nursing, or equivalent with 12+ years of experience in biotech, pharmaceutical, or CRO industry, including at least 8 years of clinical research and development experience, and ability to travel (~20%).
• Candidate must be willing to develop and support direct reports. Prior experience is preferred.
• Strong working knowledge of FDA and EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Experience in oversight of contract service providers.
• Excellent leadership, organizational, communication, and teamwork skills.
• Ability to adherence to timelines, and creative approach to problem solving.
• Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Publisher.
As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs and stock options reflect Relypsa’s high regard for our employees.
NOTE: This position description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Relypsa is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.