Senior International Project Leader (m/f/x)

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Date: 27-Oct-2020

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

Affiliate: Daiichi Sankyo Europe GmbH

 

Passion for Innovation. Compassion for Patients.™

Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter. For more information: www.daiichi-sankyo.eu.

 

For our European headquarters in Munich we are seeking highly qualified candidates to fill the position:

 

 

Senior International Project Leader  (m/f/x)

 

 

Role and Responsibilities:

  • Responsible for the conception, planning, conduct and evaluation of interventional (phase IIIb, IV trials) and non-interventional studies (eg. classical non interventional studies, , Post Authorization studies, Epidemiological Trials
  • Take ownership of a clinical projects from the beginning till closure, provide leadership and deliver studies on time and on budget with high quality.  
  • Take the lead in a matrix by managing remotely and by understanding the European needs. Take leadership for all divisions involved (eg, contract research organization, Medical Affairs, PRA/HEOR, Pharmacovigilance, Biostatistics) 
  • Interface with DS Affiliates by understanding the needs and by involving the Medical Liasons in the trial. 
  • Make decisions related to process efficiencies and budget
  • Development of risk mitigation strategies for key operational tasks
  • Generation, review and approval of trial related documents (eg. protocol, CSFs, reports, project plans), supervision of the preparation of study related documents for submissions to ECs/CA and other regulatory bodies 
  • Generation and review of trial and disease related medical material and communication (incl. publications) 
  • Daily management and supervision of CROs and other 3rd party service providers; active participation in the related outsourcing and procurement processes 
  • Best practice sharing and study management standards implementation 
  • Study and disease area related interactions with KOLs and HCPs in Steering Committees, Advisory Boards, Data Safety Boards and Investigator Meetings 
  • Participation in development program related internal and external trainings and seminars 
  • Tight collaboration with Medical Affairs assuring study designs are in accordance with the global medical strategy as well as with HEOR/PRA ensuring optimal reflection of pricing and reimbursement needs in all relevant studies
  • Participation in global committees
  • Oversee progress of Investigator Initiated studies 
     

 

Professional experience and personal skills:

  • MD or natural science education and degree, doctorate preferred  
  • Minimum of 5 years relevant experience in international clinical research and international project management, with a focus on non-interventional studies in a multi-national pharmaceutical industry and/or CRO environment
  • Thorough knowledge of the management of EU wide non-interventional trials including regulatory local requirements, guidelines, and other relevant health system/legal requirements specifically related to late-phase clinical research
  • Strong knowledge of Clinical Research Principles (ICH –GCP) 
  • Leadership experience with active participation in multicenter trials 
  • Documented track record in multidisciplinary, cross-functional interactive collaboration with Medical Affairs, HEOR/PRA and other relevant key functions; familiar to work in an international matrix organization
  • Fluency in English and at least one other European language, both oral and written communications 
  • Demonstrate sound knowledge, flexibility, creativity and proactivity as well as practice adaptive change management and engagement in order to guarantee clinical operational excellence and continuous improvement
  • Proven Project Management skills in a matrix environment 
  • Able to work proactive by anticipating potential issues with a clinical trial. 
  • Show empathy, respect and fairness
  • Live a culture of cooperation and team-work and take action to prevent and solve conflicts
  • Ability to work independently and as part of a team
  • Work proactively and encouraging others, show assertiveness
  • Strong communication, negotiation, decision making and presentation skills
  • Effective project planning, conduct and supervision abilities 
  • Analytical and systematic thinking, proactive problem identification, solution orientated, ability to drive project and clinical requirements

 

 

What we offer:

 

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.