*** Urgently Needed In Sweden – Clinical Development Director, 12 Months, Full FTE, Biotech ***

*** Urgently Needed In Sweden - Clinical Development Director, 12 Months, Full FTE, Biotech ***

Job Type: contract
Region: Europe
Location: Unspecified
Salary: Competitive
Posted: 26th May 2020
Ref: JLSWEDBIO2020

I am currently partnered with a Biotech company based in Stockholm who are Desperately seeking an experienced Clinical Development Director.

My client currently has 2 x Phase I studies and is looking to progress further and needs the correct person in place to perform oversight of the CRO in order to achieve the results required, with an additional trial looking to start in the latter end of 2020.

With an outstanding team, you will be involved with a very tight and well organised team. There will be an expectation to hit the ground running and assist the team when required.

With most freelance/consulting positions you will not be given the opportunity to become such a big part of the team, however they have requested that this person will play a big part in the team and have a future with the company.

You will be given 2 weeks for a hand over by the current Project Manager, before they go on parental leave.

Responsibilities as the Clinical Development Director:

(Will include but not limited to)

  • Formulation of clinical protocols and related documentation in collaboration with the Clinical Operations Team (COT)
  • Lead and matrix manage the global multidisciplinary COT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures
  • Identify sites and manage study set-up
  • Lead the clinical trial protocol development process
  • Responsible for ordering and management of clinical trial materials
  • Support the CRA’s on study related questions and serve as point of contact for managing/ answering questions relating to trial procedures and subjects eligibility
  • Responsible for set up and maintenance of the Trial Master File for assigned studies
  • Regularly update all trial information databases in order to manage accuracy of information
  • Approve for all necessary centre payments
  • Co-ordinate pre-audit activities for nominated projects
  • Contribute to identification and evaluation of new centres suitable for performing TM studies in healthy volunteer and patients.
  • Extensive experience in an oversight role

Requirements of the Clinical Development Director:

  • 5 years of experience as a Directorial/ Project Manager experience
  • 5 years of experience as a Freelancer/Consultant
  • Extensive oversight experience/ Vendor and CRO Management
  • Life Science Degree
  • Small company and or Biotech experience
  • Motivates staff and ensures team effectiveness through eliciting feedback
  • Excellent communication, presentation and problem solving skills.
  • Previous experience in the management/coaching of direct reports.

If this position is for you, or you are eager to find out more then do not hesitate to get in touch with me directly for a confidential conversation on:

Jlambert@barringtonjames.com

or call on:

+44 1293 776644

@BarringtonJames
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