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Clinical Development Manager (m / f / d)

Clinical Development Manager (m / f / d)

PAION Pharma GmbHAachen, DE
Vor 30+ Tagen
Anstellungsart
  • Vollzeit
Stellenbeschreibung

Your tasks

For our team in Aachen (Germany) we are currently searching for a Clinical Development Manager (m / f / d)

Overview : The Clinical Development Manager is responsible for continuously advancing the knowledge of PAION Pharma’s medicinal products in intensive care and anaesthesiology within the global medical / scientific community and provides in-depth scientific, clinical and educational support to the external medical / scientific community and to internal groups, such as clinical, marketing and commercial teams, PAION Pharma partners and licensees.

Your tasks & responsibilities :

  • Acquire and utilise profound therapy area and in-depth medicinal product knowledge to engage with external and internal stakeholders by scientific dialogue, presentations and publications
  • Develop and maintain long-term professional relationships with medical specialists, healthcare professionals, key opinion leaders and clinical study investigators
  • Develop clinical trials and studies (RCT, NIS, RWE, register, survey, etc.) for PAION Pharma’s medicinal products per global strategy, regulatory requirements and scientific needs
  • Write clinical trial / study documents like protocol, informed consent form, various study plans, clinical study report and articles for publication
  • Medically and scientifically oversee and monitor ongoing clinical trials / studies and statistical analyses in terms of safety, study objectives and protocol adherence
  • Train, provide and collaborate on latest clinical insights with external stakeholders like HCPs, research groups and professional societies as well as with internal teams like sales, marketing and clinical operations
  • Ensure that prevailing legislation, ICH GCP, the ethical committees, SOPs and medical compliance requirements are fulfilled
  • Administering medical support to the Brand team including Identification of HCPs and Advisory boards

Your profile

  • MD or equivalent, preferably with experience within intensive care / anaesthesiology
  • Minimum 3 years of experience in clinical development and / or medical affairs and a thorough understanding of the medicinal product life-cycle.
  • Proven track record of designing clinical trials and study protocols as well as supervision of ongoing clinical trials and studies
  • The ability to understand, process, communicate and present scientific information to a high standard
  • Precise expressiveness, excellent medical writing skills of clinical trial / study protocols and related study documents as well as articles for publication
  • Demonstrative external customer focus with strong networking capabilities and integration with KOLs
  • Capacity to maintain the highest ethical standards, with a working knowledge of relevant clinical regulations and industry standards including ICH GCP
  • Fluency in English; ideally, proficiency in German or Dutch

    • Why us?

  • A diverse and challenging role within a dynamic company
  • Short communication channels, open doors and helpful, committed colleagues
  • New office facilities with modern work and think spaces, and well-equipped meeting rooms and area for socializing including free beverages and refreshments
  • State-of-the-art IT equipment
  • Flexible working hours with partial home office for a good work-life-balance
  • Very convenient location in Aachen with good connections by bike, bus and car. Close connection to A44 freeway. Showers for athletes also available
  • 30 days vacation

    • PAION contact details

    Do you want to work in an international and dynamic environment and would like to play an active role?

    We look forward to receiving your application preferably by email, at  [email protected] .

    If you have any questions, send an email at  [email protected] .

    About us

    PAION Pharma GmbH, headquartered in Aachen, Germany, is a specialty pharmaceutical company in the field of anaesthesia and critical care specialising in innovative active pharmaceutical ingredients for use in outpatients and hospitals.

    PAION Pharma GmbH is part of the Humanwelll Healthcare Group.

    www.paionpharma.com