SUMMARY:

This position describes the principal clinical person on a project at pre-clinical or early clinical development stages. The projects are likely to combine neurology and psychiatry indications and the key task will be to understand what biology can be targeted by the molecule under development, how this biology can be explored in the clinic and how results of this exploration can lead to an indication selection and to structuring a clinical development program for this indication. The projects will be multi-faceted, and this individual will lead a matrix team.
Location: Manhattan, New York, US

ESSENTIAL FUNCTIONS

  • Responsible for taking a molecule from the pre-clinical phase to the clinical phase of development
  • Collaborate with research, experimental medicine and other functions to develop a clinical plan for characterization of safety, tolerability and pharmacological action for a new molecule
  • Responsible for designing clinical studies that allow implementation of this clinical development plan and carries overall responsibility for delivering these studies
  • Able to analyze data from clinical studies and to make Go/No Go decisions for explored indications and/or symptoms
  • Leads an early phase multi-disciplined clinical project/study team
  • Contributes to the creation of all required clinical documents, including protocol synopses, clinical study reports, investigator brochures, clinical portions of regulatory documents, such as annual reports, initial clinical research applications, briefing books for regulatory meetings and submission packages.
  • Provides medical monitoring for clinical trials or supervises an external medical monitor if medical monitoring services are outsourced
  • Able to maintain an open, flexible approach to decision making based both on rigorous scientific analyses and Lundbeck business needs

REQUIRED EDUCATION, EXPERIENCE and SKILLS

  • MD (Medical Physician) or PhD with prior clinical/clinical research experience within neurology or psychiatry
  • 2+ years of experience in clinical research within an academic or pharmaceutical / biotech setting
  • Ability to lead cross-functional matrix teams in a highly collaborative fashion
  • Evidence of a proactive and creative approach
  • Able to maintain an open, flexible approach to decision making based both on rigorous scientific analyses and business needs
  • Shows the flexibility to work across disease areas within psychiatry and neurology and be open to look at areas beyond their immediate specialization

PREFERRED EDUCATION, EXPERIENCE AND SKILLS

  • MD (Medical Physician)
  • Enthusiastic about learning and exploring new pharmacological and biomarker approaches
  • Pro-active, outgoing, goal-oriented, dynamic, responsible and decisive
  • Team player and able to work independently at the same time
  • Able to maintain a broad overview and keep enough level of detail

TRAVEL

  • Willingness/Ability to travel up to 30% domestically and internationally

For more information and application see the Lundbeck website.