Director, Clinical Operations

Lieu: United States - Redwood City

Fonction: Clinical

Compagnie: Relypsa

Niveau de Séniorité: Director

Votre profil

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 

A propos de nous

Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.

Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Pour de plus amples informations, veuillez consulter http://www.viforpharma.com/fr/a-propos-de-vifor-pharma/qui-sommes-nous.

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