Project Lead Patient Reported Outcomes (PRO) (m/w/d).

Job ID: 11516

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Medical Affairs
Type of employment
Project Consulting
Entourage is a management and personnel consultancy focusing on pharmaceuticals, medical technology and health care. The company, which is based in Munich and Basel, recruits experts for the leading life science companies in the DACH region by placing permanent scientific employees and consultants. With Project Consultants, Entourage implements projects for its clients via highly qualified temporary employment agencies and work contracts. With the Entourage Task Force (ETF), Entourage bundles selected interim managers and management consultants into a top-class consulting unit that implements pharmaceutical and medical technology solution scenarios in consulting projects on an interdisciplinary basis.
  • Lead the development and execution of a global, comprehensive and scientifically rigorous Patient Reported Outcomes (PRO) strategy incl. gap identification that is aligned with the clinical, regulatory, commercial and market access strategies for development assets
  • Design and lead the generation of PRO evidence (qualitative/quantitative methods) in line with the international scientific standards and Health Authority regulations, in the context of PRO tool development and validation to achieve "fitness for use" to inform the endpoint model of pivotal clinical trials
  • Coordinate a common global strategy and compile PRO evidence package for submissions to Health Authorities and Health Technology Assessment (HTA) agencies in securing marketing authorization, label enhancement and/or reimbursement as well as prepare, participate and post proceeding of interactions with these authorities
  • Collaborate with Clinical Operations on licensing/translation/linguistic validation and ePRO transfer of PRO and for approval of final language versions
  • Manage study design and execution of contracted research projects (budget negotiations, quality assurance of work conducted by vendors) and provide technical expertise in analysis and dissemination of clinical outcome assessment data
  • Represent the PRO expert function and manage effective communications with various internal global/regional team(s)
  • disseminations in line with internal communication
  • Identify, evaluate and oversee a global network of consultants and contract organizations to execute the PRO evidence generation deliverables 
  • Doctoral degree (PhD, DRPH, ScD) in psychometric research, health pharmacoeconomics or in a clinical discipline (medicine, pharmacy) or master’s degree (MSc, MPH) in health services research, public health or health/pharmacoeconomics
  • Several years of professional experience in the PRO area in a pharmaceutical company and/or related consultancy company or in academia. It is essential to have experience in the following areas:
    • PRO strategy generation and implementation in clinical development
    • PRO instruments’ development
  • Technical competencies in the development, validation and use of PROs/clinical outcome assessment instruments
  • Expert knowledge in scientific writing of psychometric analysis plans, observational study concepts, protocols, reports and regulatory documentation; programming and analytical skills in SAS or other statistical packages are of major advantage.
  • In-depth knowledge of global health care systems and of clinical research, especially clinical phase 2 and phase 3 efficacy studies and drug development strategies

 The following overarching skills are important:

  • Very good interpersonal and communication skills along with ability to understand and respond to multiple internal and external customer demands as well as competency to manage and handle conflict constructively with limited supervisory support
  • Highly result-oriented while tackling complex strategic and analytical problems
  • Excellent oral and written English communication skills