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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Medical Director Clinical Development Psychiatry


Reference:SCAPQK-674438s Location: Dublin
Republic of Ireland
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Medical Director

Medical Director Clinical Development Psychiatry
Our client, a growing biotech organisation are currently recruiting for a Medical Director to join their organisation on a permanent basis. The ideal candidate will have clinical development experience in the area of psychiatry.


Responsibilities

  • Lead the execution of one or more of the organisations clinical studies and development plans while meeting standards of excellence for ethics, scientific merit and regulatory compliance. This would include Protocol design, outsourcing partner management, to results interpretation and reporting
  • Hands-on leadership role of one or more projects within the Clinical Development function and activities (in-house and outsourced), working closely with management, external Regulatory Affairs, in- and external CMC, preclinical, and other functions
  • Ability to deliver in a lean and changing environment by effectively using external partners
  • Play a lead role in developing the organisations KOL and investigator network and building support for the clinical programme. Ideally, the Medical Director will have an established network of KOLs in psychiatry

Requirements
  • Medical qualification, with relevant psychiatry clinical development experience
  • Experience with early and late-stage clinical development, registration, and commercialisation, with experience of working with psychiatry therapies
  • Preference for staying close to clinical execution/clinical operations while also being able to bring a strategic perspective
  • Hands-on experience in pharmaceutical clinical study design and operational management in CNS drug development, including several years in a senior leadership role
  • Some experience in the management of outsourced development programme
  • The attitude and ability to be effective in a lean, small company environment
  • Proven aptitude in continuously developing own scientific and medical knowledge. Strong analytic capability and ability to “make sense of data”
  • Flexible, able to adjust, embrace and drive change
  • Resilient, energetic and enthusiastic, a good communicator, with excellent leadership, management and influencing skills.

Desired criteria
  • Significant experience in depression
  • Regulatory experience, including up-to-date knowledge in current regulatory processes and rules, including for example fast-track reviews
  • PhD or other advanced qualification