Für unseren Klienten, ein global agierendes Pharma-/Biotechunternehmen mit Standort in Berlin suchen wir einen:
Projektleiter Patient Reported Outcomes (PRO) (m/w/d)
Stellenbeschreibung
- 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), 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)
Profil:
- Doctoral degree (PhD, DRPH, ScD) in psychometric research, health pharmacoeconomics or in a clinical discipline (medicine, pharmacy) with PRO orientation preferred 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
- Qualitative work to establish content validity including literature reviews and conduct of observational studies
- Quantitative work to assess psychometric properties and CID/CIR
- Inlicensing and translation/linguistic validation
- PRO clinical trial result assessment and interpretation
- PRO dissemination and scientific communication
- Support of PRO-related interactions with Health Authorities (experience with Health Authorities interactions would be essential)
- Support of HTA interactions, submissions and P&R negotiations
- Knowledge in the following areas is needed:
- 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
Könnte dies Ihre nächste Herausforderung sein? Ich freue mich auf Ihre Bewerbung!
Ihr Kontakt bei Kelly:
Thomas Jin
Value Recruiter - Kelly Scientific Resources
089 384 090 7
thomas.jin[at]kellyservices.de
About Kelly
Kelly Services ist Ihr Spezialist für die Vermittlung von Fach- und Führungskräften. Wir bringen Sie mit genau dem Unternehmen zusammen, das zu Ihnen passt. Eine Vermittlung über uns ist persönlich, vertraulich und unkompliziert.
Unser Versprechen
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