Patient Reported Outcomes Project Leader
Bayer AG
Berlin, Germany
vor 10 Tg.

Your tasks and responsibilities

  • Lead the development and execution of a global,comprehensive and scientifically rigorous Patient ReportedOutcomes (PRO) strategy incl.
  • gap identification that isaligned with the clinical, regulatory, commercial and market accessstrategies for development assets

  • Design and lead the generation of PRO evidence(qualitative / quantitative methods) in line with the internationalscientific standards and Health Authority regulations, in thecontext of PRO tool development and validation to achieve "fitnessfor use" to inform the endpoint model of pivotal clinicaltrials
  • Coordinate a common global strategy and compile PROevidence package for submissions to Health Authorities and HealthTechnology Assessment (HTA) agencies in securing marketingauthorization, label enhancement and / or reimbursement as well asprepare, participate and post proceeding of interactions with theseauthorities
  • Collaborate with Clinical Operations onlicensing / translation / linguistic validation and ePRO transfer ofPRO and for approval of final language versions
  • Manage study design and execution of contractedresearch projects (budget negotiations, quality assurance of workconducted by vendors) and provide technical expertise in analysisand dissemination of clinical outcomeassessment data
  • Represent the PRO expert function and manageeffective communications with various internal global / regionalteam(s), as well as appropriate external forums andmeetings
  • Maintain awareness, education on and implementationof new methods, tools and data sources to ensure study methodsrepresent current state of science, as well as assessment andinterpretation of relevant literature, scientific disseminations inline with internal communication

  • Doctoral degree (PhD, DRPH, ScD) in psychometricresearch, health pharmacoeconomics or in a clinical discipline(medicine, pharmacy) with PRO orientation preferred ormaster’s degree (MSc, MPH) in health services research,public health or health / pharmacoeconomics along with several yearsof professional experience in the PRO area
  • Several years of experience in a pharmaceuticalcompany and / or related consultancy company
  • Technical competency in the use ofePRO / e-clinical outcome assessment and linguisticvalidation of clinical outcome assessments as well asin psychometrics or statistics
  • Expert knowledge in scientific writing ofpsychometric analysis plans, study concepts, protocols, reports andregulatory documentation
  • In-depth knowledge of global health care systemsand of clinical research, especially clinical drug studies and drugdevelopment strategies
  • Excellent process and project managementskills
  • Very good interpersonal and communication skillsalong with ability to understand and respond to multiple internaland external customer demands as well as competency to manage andhandle conflict constructively with limited supervisorysupport
  • Cross-functional team leadership experiencedesirable
  • Excellent oral and written English communicationskills
  • Your application

    Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives?

    Then send us your online application including cover letter, CV and references.

    Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.

    We are committed to treating all applicants fairly and avoiding discrimination. Bayer begrüßt Bewerbungen aller Menschen ungeachtet von ethnischer Herkunft, nationaler Herkunft, Geschlecht, Alter, körperlichen Merkmalen, sozialer Herkunft, Behinderung, Mitgliedschaft in einer Gewerkschaft, Religion, Familienstand, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität oder einem anderen sachfremden Kriterium nach geltendem Recht.

    Wir bekennen uns zu dem Grundsatz, alle Bewerberinnen und Bewerber fair zu behandeln und Benachteiligungen zu vermeiden.

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