Senior/Principal Project Clinical Pharmacokineticist

Senior/Principal Project Clinical Pharmacokineticist

Boehringer Ingelheim

Biberach, Germany

THE POSITION

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance.

Tasks & responsibilities as Senior Project Clinical Pharmacokineticist

  • In your new role you provide expertise to the overall pre-clinical and clinical drug development of New Chemical- & New Biological Entity (NCE & NBE) candidates in the areas of CNS and Retinal Health (RH) diseases.
  • The design of the drug-drug interaction strategy and the support of formulation development/biopharmaceutical aspects is part of your profile.
  • You provide input concerning clinical study protocols and reports, clinical development plans, Investigator’s Brochures and the Clinical Pharmacology section of INDs, CTA’s, NDAs/BLAs or respective label texts.

Additional tasks as Principal Project Clinical Pharmacokineticist

  • You act as Clinical Pharmacology- and Pharmacometrics Integrator (CPPI), being accountable for all Clinical Pharmacology and Pharmacometrics aspects of a compound.
  • In early- and late-stage clinical drug development teams and towards regulatory authorities worldwide you represent these Clinical Pharmacology and Pharmacometrics aspects mentioned above.
  • In addition, you act as key contact and representative for assigned CNS/RH projects in strategic Boehringer Ingelheim (BI) teams.
  • Furthermore, you develop, implement and promote innovative methodologies and approaches whilst providing training and expert advice for colleagues.
  • You represent Clinical Pharmacology for due diligence projects and for various initiatives and working groups within BI and on external platforms.

Requirements as Senior Project Clinical Pharmacokineticist

  • Ph.D. in Pharmaceutical- or Life Sciences with long-standing experience in clinical pharmacology or (non-) clinical PK/PD within the pharmaceutical industry
  • Advanced knowledge of Clinical Pharmacology aspects in drug development such as general Pharmacokinetics & Pharmacodynamics (PK/PD) principles, drug-drug interactions (clinical and pre-clinical), biopharmaceutics and/or Clinical Pharmacology trials in special populations, including pediatrics and PK-safety trials (ECG)
  • Sound understanding of drug metabolism and PK/PD, including working knowledge in pharmacokinetic software programs (e.g., WinNonlin). Expertise with modeling tools incl. PBPK is preferred
  • Solid understanding of the principles of clinical and pre-clinical drug development for NCE and NBE
  • Knowledge concerning guidelines from the main regulatory agencies such as EMA, FDA & PMDA
  • Basic knowledge in biomarkers, pharmacogenomics, and biostatistics
  • Distinct leaderships skills with excellent oral and written communication-, negotiation- and presentation skills

Additional requirements as Principal Project Clinical Pharmacokineticist

  • Long standing experience in relevant clinical area with significant time spent in an international environment
  • Distinct leaderships skills
  • Great sense of responsibility and interest in interdisciplinary work

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© EuroJobsites 2021

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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