Für Freelancer: Global Director Clinical Operations

  • Jena, Thüringen
  • Freiberuflich
  • Vollzeit
  • 1 Monat her
Freelancer Projekt -
Primary Job Function

For both new and existing products; supports ARDx clinical leadership by generating
clinical studies and publications. Develops and trains both our marketing
and sales organizations as well as customers and physicians around the world. Provides input to the design of
new products; technologies and OEM opportunities.

Core Job Responsibilities
Identifies sites; negotiates contracts; writes study protocols; monitors study progress; analyzes results and
works with investigators to publish papers by ARDx worldwide. Responsible lead for pre- and post-market clinical studies.
Work and publications must be accepted as clinically important and useful in moving accepted science
forward and/or influencing clinical or medical policy.
Prepares clinical posters and abstracts and presents at key professional meetings around the world.
Leads cross functional team involved in developing patient and physician education materials.
Works with R&D scientists to identify and evaluate markers for new disease areas or product improvements; technologies and intellectual properties.
Acts as a liaison between Customers/Quality/Regulatory and technical organizations when clinical issues
Must comply with and enforce all Office of Ethics and Compliance guidelines.

Accountability Scope
As a member of the Clinical Affairs organization; he is responsible for the initiation, successful conduction, monitoring and documentation of pre-market clinical studies as well as post-market clinical studies. Job results affect ARDx goals.

Minimal Education
Knowledge of regulations and standards affecting IVDs and Biologics.
Ph.D. in Sciences / MBA highly desirable. Master in Science at a minimum.

Minimum Experience / Training required

Knowledge of regulations and standards affecting IVDs and Biologics.
5-10 years product development/clinical management experience.
2-4 years business unit or general management experience.
Must have previously developed external relationships with key scientists or medical professionals.
Must have previously established and executed on Clinical Affairs and/or R&D plan.
Industry, product and customer knowledge required.
Must have strong interpersonal skills, good communication skills and clinical writing skills.
Demonstrated leadership capabilities.

Desired Experience
Knowledge or education in Infectious and vector-born diseases
Experience managing CROs
Knowledge of FDA, CE, ERPD and WHO PQ regulations