Clinical Trial Management - Head of Clinical Bioanalytical Operations (all genders)

Posted 10 Jan 2020

Darmstadt, Hesse - Germany

Req Id 201497

Details

 

A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 


Your role:

The Head of Clinical Bioanalytical Operations is responsible for developing and implementing bioanalytical outsourcing strategies, efficiently managing CROs for given projects, and delivering validated clinical bioanalytical and immunogenicity assays & data. This role is accountable for ensuring outsourced clinical bioanalytical and immunogenicity activities are performed according to the agreed timelines and quality and in compliance with current guidelines and internal standards. The incumbent will assure all aspects necessary for contracting studies are in place. This includes developing and maintaining a strong working relationship with support functions (Procurement, Legal, Quality Management). In addition, leadership of the team that is responsible to outsource and monitor the clinical pharmacokinetic and immunogenicity sample analysis at the bioanalytical vendors and ensure timely delivery of results.  

 

Who you are: 

  • Minimum Master’s degree in a life science or related discipline, additional qualification preferable
  • 8 - 10 years’ experience, in clinical and drug development in the pharmaceutical/biotech/CRO industry, of which at least
  • 5 years of experience in the development, transfer to CRO and validation of bioanalytical assays, monitoring of PK/ADA or Biomarker analysis to support preclinical and clinical studies in drug development.
  • Knowledge of GLP, GCLP guidelines, ICH-GCP, clinical trial process, other relevant Guidance documents (from ICH, FDA, EMEA etc.), and of regulations and requirements for analysis of clinical samples
  • Keeping abreast with modern and novel technologies in the bioanalytical space, regulatory guidance, industry best practices, White Papers relevant to clinical bioanalysis to ensure practices are consistent with regulatory expectations and high scientific standards
  • Prior experience in leading a team, resource management, talent acquisition, and developing employees
  • Demonstrated experience in collaborating with other functions in a complex matrixed organization
  • Strong project management skills, willing to take on and build efficient business processes, able to identify risks and implement mitigation strategies
  • Strong communication skills, both written and verbal

 


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Apply Now

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