Job Details

Position purpose

Provides clear medical leadership in the Study team,  working  in close collaboration with the other members of this cross functional team, in order to provide reliable, high quality study data within time and budget  .

Key Accountabilities/Responsibilities:

1. Provide medical leadership  to the study teams , including creating clinical trial protocols while  implementing the latest scientific information, contribute to site selection ,  contribute to review and approval of  study protocols and  amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials
2. Real time Medical Monitoring of clinical studies:   ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early . Pro-active escalation and correction  of issues  in consultation with the Global Medical Indication Lead
3. Interpret the   clinical trial  data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication Lead
4. Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities,  prepare and present material to   the study executive and independent safety committee if  applicable;  medical  training of site staff at Investigator meetings;  CRA training in new indications
5. Ensure study compliance for all medical aspects  by understanding and applying all relevant SOPs and GCP
6. Closely collaborate  with the cross functional study  team members in order for  medical  risks, issues, and results to be  clear to all involved parties
7. In case more than 1 physician is working on the protocol , a primus inter pares will be appointed and he/she will ensure that  answers to questions  from sites /IRBs RAs, eligibility and protocol deviation decisions will be harmonised across medics  

Desired Skills and Experience:

• Medical Doctor; relevant specialty education preferred ( e.g. neurology, hematology, dermatology , immunology, rheumatology, internal medicine,  pediatric, )
• Some experience in industry preferred
• Excellent English, both written and spoken  is a must, as well as ability to travel.
• Proven  interpersonal skills enabling to lead a study  team,  while recognising individual expert competencies, providing  medical advice and evaluations exercising  judgement in which issues need to be escalated immediately  
• Pro-active problem solver with negotiation skills ,  remaining sensitive to the different  cultural needs in a global organisation
• Strong communication skills to ensure  close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties.  A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action,