Clinical Pharmacokinetic Expert (m/f/d)

AiCuris Anti-infective Cures AG

Clinical Pharmacokinetic Expert (m/f/d)

AiCuris Anti-infective Cures AG

Berlin, Germany

The Powerhouse for Anti-infectives - Committed to making the difference

AiCuris is a clinical stage biopharmaceutical company developing novel therapeutic candidates for the treatment of serious and potentially life-threatening infectious diseases. Our front-runner drug Prevymis®, a prophylactic treatment for CMV infection in transplant patients, has been outlicensed and is marketed globally since 2017. Prevymis® is followed by an innovative pipeline of antiviral and antibacterial agents including our wholly owned therapeutic candidate Pritelivir, which is currently in phase III clinical development. Passionate about our mission to develop anti-infective medicines for patients in need, a team of internationally recognized experts is driving our research development.

Ready to fight against infectious diseases? Join our team!

Your role will be to provide clinical and optimally also pre-clinical pharmacokinetics (PK) input, analyses and scientific PK-concepts for AiCuris projects. You should design and plan, conduct and report international clinical trials from pharmacokinetic point of view in the respective subject area in collaboration with the AiCuris project team, external consultants, service providers, and ethical/regulatory bodies.

Responsibilities

  • Responsible for designing and planning PK-focused clinical investigations;
  • Responsible for PK monitoring, PK input, online follow-up of patients' PK data, participation in the preparation of statistical analysis plans and tables, figures and listings of clinical trials;
  • Responsible for the planning, analyzing, reviewing and reporting of PK/PD and popPK;
  • Writing of PK chapters in trial protocols and reports as well as critical review of these documents including quality check;
  • Writing/reviewing the clinical PK part of the investigator brochure and other regulatory documents and answering questions to the authorities;
  • Preferably able to support biostats for analysis of clinical trial data.

Skills and qualifications

  • Successful graduation as pharmacist, physicist, mathematician or pharmacologist;
  • More than 5 years of proven experience in planning and analyzing clinical PK trials, specifically Phase 1 and 2 trials as well as performing PK/PD and popPK analyses in the pharmaceutical industry or academia;
  • Optimally also experience in designing and planning preclinical PK experiments, but not a prerequisite;
  • Preferably hands-on biostatistical knowledge and working experience;
  • Ability and experience in working as a team; in-house, with CROs, experts and opinion leaders;
  • Openness and respect for diversity;
  • Leadership, organization, interpersonal communication, and presentation skills;
  • Results-oriented, capable of setting priorities and managing high workload at times;
  • Small biotech mentality and flexibility to accept and perform the tasks of their directly reporting workers and colleagues across projects if necessary;
  • Fluent in business English; writing and speaking in German would be beneficial.

What we can offer

  • A dynamic and family friendly atmosphere with flexible working hours;
  • Working with highly motivated professionals in international and interdisciplinary teams;
  • A culture of independent thinkers embracing debate and initiative;
  • Scientific excellence in research and development aiming to make a difference for patients in need;
  • Flexible combination of on-site and remote work;
  • Regular trainings with opportunities to grow;
  • Attractive remuneration and company pension scheme;
  • A wide range of offers in terms of health care and work-life balance.

How to apply

Interested in joining our team?

Then apply online.

If you have any questions, please do not hesitate to contact us at +49 (0)202 317 63 - 0.

Note for headhunters: We are not interested in support. Thanks!

AiCuris Anti-infective Cures AG
Human Resources
Ms. Ariane Mlitzko Oliveira
Friedrich-Ebert-Str. 475/Build. 302
42117 Wuppertal, Germany
www.aicuris.com

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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