Non-Clinical Study Director

Location Oss, Gemeente Oss, North Brabant
Discipline: Biotechnology, Pharmaceutical
Job type: Permanent
Contact name: Selin Ozbeden

Contact email:
Job ref: 13352
Published: 21 days ago
For one of our clients I'm looking for a Non-Clinical Study Director with passion for preclinical research in vivo study design.

  • Overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control
  • Ensure that studies are compliant with the appropriate GLP regulations/ISO guidance's, and all relevant international regulatory guidelines
  • Works with the appropriate individuals to design and approve the study protocol; Consults with management and others during protocol development to optimize protocol design to appropriately address study objectives
  • Coordinates the schedule and logistics of the study with sub-contractors, and relevant internal departments
  • Assures that all experimental data, including observations of unanticipated responses, are accurately recorded and verified
  • Analyzes and interprets study data, prepares study reports, and communicates results to management
  • Effectively manage multiple outsourcing studies under general supervision and produce reports per plan to achieve target deadlines
  • Responsible for communicating with outside and in-house parties to move studies forward with a sense of urgency
  • Interaction with internal experts and informing the appropriate people in a timely manner are pivotal to the performance of this role
  • Accountable for technical oversight and tracking of all study phases to ensure that timelines and quality are met.
  • Exhibits strong verbal and written communication skills and strong interpersonal and leadership skills as necessary to ensure study activities are executed smoothly and according to protocol
  • Plans and executes internal and external study team meetings
  • Assists with identifying potential collaborations
  • Provides assistance to Business Development in promoting programs
  • Bachelor or higher level degree in Pharmacy, Pharmacology, Medicine, or Sciences or other related area of study
  • Minimum 4 years of nonclinical research experience required including at least 2 years of Project Management
  • Three years’ experience as a Study Director for in vivo studies (including GLP) in a biopharmaceutical company or Contract Research Organization (CRO)
  • Proficient knowledge of regulatory and international standard guidelines and general nonclinical study protocols
  • Experience in roles of Preclinical Study Director/Study Monitor and/or experience as a Project Team Member/Representative. Other routes into the role are possible
  • Excellent communicator, self-starter, strong team player, flexible, and high level of logistical / planning ability
  • Problem solving, excellent analytic skills and risk mitigation
  • Fluent English language skills required (both written and spoken)
  • Software: Microsoft Office, SmartSheet
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information please contact Selin Ozbeden on   +31 (0)20 20 44 502