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Global Medical Program Director Haemophilia - Sweden  

Company managed [?] Still accepting applications

Posted on : 05 April 2017

Project Description


 
Introduction/Purpose
  • Our company  has an exciting and expanding portfolio, which are being developed both alone and in collaboration with a number of strategic partners. 
  • The R&D organisation comprises around 140 staff across Clinical Development, R&D Operations, Research & Translational Science, Project & Portfolio Management, Regulatory Affairs & Drug Safety. Clinical Development is a strategically important function within the R&D organisation, and our company is now looking to recruit an outstanding medically-qualified individual to become Medical Program Director within heamophilia reporting to the Head of Clinical Development.  
  • Clinical Development comprises 35 employees (including consultants) covering Medical Program Directors, Clinical Pharmacology & Translational Medicine, Clinical Operations, Data-Management, Statistics and Clinical Reporting. The department is responsible for all Clinical Development activities, including Life Cycle management.



Key Responsibilities/Scope of the Job
Including but not limited to the following
  • Overall medical responsibility in appointed clinical projects. 
  • Responsible for IB’s, protocols and reports from a medical legal perspective.
  • Responsible for medical parts in regulatory documents.
  • Ensure an appropriate and continuous medical risk/benefit assessment.
  • Execute a risk minimization at all stages to secure a sound and ethical development of a  safe drug product.
  • Establish the Clinical Development Plan (CDP).
  • Identify and coordinate contacts with external consultants and clinical experts.
  • Establish relevant external advisory boards, responsible for content.
  • Support and contribute to overall project deliverables.
  • Ensure that productive, innovative and high quality development is performed.
  • Be the internal and external spokesperson for medical aspects in a given project.
  • Secure the Benefit evaluation in Benefit: Risk team in partnership with Drug Safety.
  • Provides medical review and contribution to applicable Regulatory, and Drug Safety document.


Qualifications
  • Medical Doctor
  • Medical &Scientific insight within haemophilia
  • 5 years of pharmaceutical industry experience 
  • Clinical and academic experience 
  • Medical Scientific excellence  
  • Excellent communication and presentation skills
  • Initiative, Results oriented and delivery focus
  • Collaborative with experience from working in clinical study team
  • Experience from FDA and EMA interactions is a plus.
  • International and/or global HQ experience with track record in virtual communication, engagement and leadership.



Personal Attributes
  • Collaborative, a team player with strong interpersonal skills
  • Able to work effectively in a team setting and interact respectfully with people of different cultural, seniority and functional backgrounds
  • Sense of accountability and ownership; Able to work independently
  • Engaged, driven, analytical
  • Flexible and able to operate in a quickly changing environment
  • Integrity 
  • Prioritization and time management skills