Director, Clinical Operations

Location: United States - Redwood City

Division: Clinical

Company: Relypsa

Seniority Level: Director

About You

Responsibilities:
  • Ensure adherence to ICH GCP, in particular through service provider oversight and interaction with investigational sites, within the assigned country/territory 
  • Contribute to and support successful execution of clinical trial protocols 
  • Cross-functional matrix team member
  • Support the Global Clinical Operations team

Tasks: 
  • Manage, develop, and support the Clinical Trial Educators team, based in North America, through regular coaching and mentoring sessions, as well as providing guidance to direct reports on individual career paths
  • Establish relationship with investigational sites and act as sponsor interface 
  • Champion site specific recruitment plan and strategies, mitigate barriers to patient recruitment with stakeholders 
  • Interact with global Vifor Clinical Study Team, local Vifor medical staff, external Service Providers, and investigational site staff (including investigators and study coordinators) to assist with timely, efficient and high quality trial delivery throughout all stages of the study
  • Support operational excellence of global clinical trials through vendor oversight activities, including but not limited to accompanied visits, monitoring report review, tracking of trial related metrics and input to  respective project  plans
  • Member of the global Clinical Study Team
  • Provide input into department SOPs and processes, and involvement into investigational site inspection and audit readiness activities

Qualifications:

The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.

Minimum Requirements

Education
  • Relevant Bachelors Degree (BSc) or Health Care Degree (e.g. RN)
  • Higher Degree (e.g. PhD, MD, PharmD) is preferred

Experience
  • Minimum of 10 years’ relevant experience in the pharmaceutical or biotechnology industry, involving direct contact to study sites and KOLs
  • Good understanding of the drug development process and clinical trial execution
  • Experience in oversight of contract service providers
  • Familiar with clinical trial documentation and regulatory requirements
  • Excellent knowledge of ICH GCP requirements
  • Excellent user of Office Programs (Word, Excel, PowerPoint)
  • Fluent in English. Additional languages are a plus
Mobility
  • Ability to travel (local and international travel required)
  • Position location can be company HQ, Redwood City Ca or remote 

About Us

Relypsa, Inc., a Vifor Pharma Group company, is a biopharmaceutical company focused on the development and commercialization of late-stage medicines in the iron deficiency, nephrology and cardio-renal therapeutic areas. Relypsa is committed to delivering innovative therapies and improving the lives of patients with serious and life-threatening conditions that are often overlooked and undertreated. The Companys first medicine, Veltassa® (patiromer) for oral suspension, was approved by the U.S. FDA in October 2015, making it the first approved medicine for the treatment of hyperkalemia in more than 50 years. More information is available at www.relypsa.com or check out our LinkedIn page.

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