Senior Expert Patient Reported Outcomes (PRO) (m/f/d)

Our client is one of the most traditional German DAX-30 companies in the pharmaceutical industry and generates sales of almost € 20 billion worldwide in the Healthcare division with more than 60.000 employees.

We are looking for a committed and motivated person for the position of a

Senior Expert Patient Reported Outcomes (PRO) (m/f/d)

  • Bereich:

    Medical

  • Berufssparte:

    Zulassung/Regulatory Affairs

  • Arbeitsregion:

    Berlin

  • Art der Anstellung:

    permanent

  • Kennziffer:

    26492

  • Aktualisierung:

    2021-03-05

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Your tasks

  • 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 and to support labelling claims.
  • 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), as well as appropriate external forums and meetings
  • Maintain awareness, education on and implementation of new methods, tools and data sources to ensure study methods represent current state of science, as well as assessment and interpretation of relevant literature, scientific 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 (e.g. qualitative PRO development evidence, psychometric analyses, clinical outcome assessment qualification dossiers, linguistic validation activities, licensing)
  • Lead cross-functional PRO teams and provide resource and budget management for PRO related investments for projects in scope

Your qualifications

  • 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 – all with PRO orientation
  • Several years of professional experience in the PRO area in a pharmaceutical company;  It is essential to have experience in the following areas: PRO strategy generation and implementation in clinical development, PRO instruments’ development, PRO clinical trial result assessment and interpretation, PRO dissemination and scientific communication, experience with regulatory health authorities interactions, HTA interactions and submissions
  • 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
  • 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
  • Proven leadership and management skills as well as strong strategic, envisioning and critical thinking skills, with the ability to think/act both strategically and tactically
  • Highly result-oriented while tackling complex strategic and analytical problems
  • Excellent oral and written English communication skills

Your contact person

Bastian Hennlich
Senior Personalberater

Address

Optares GmbH & Co. KG
Bastian Hennlich
Heiligengeist Höfe 8
26121 Oldenburg