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(Senior) Principal Clinical Pharmacology Lead

Employer
Boehringer Ingelheim
Location
Biberach, Germany
Salary
Competitive
Start date
1 Mar 2023
Closing date
30 Mar 2023

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Discipline
R & D
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.


THE POSITION


As Clinical Pharmacology Lead you act in global development teams with a responsibility for the Clinical Pharmacology development package.

You work in a department (Translational Medicine & Clinical Pharmacology) bridging the path from early research to submission interacting with multiple functional areas within BI. You have the choice to work at the Ingelheim site in close proximity to Frankfurt am Main or the Biberach site in the southern part of Germany close to the Alpes and Lake Constance.

Discover our Biberach site: xplorebiberach.com

Tasks & responsibilities

  • As Principal Clinical Pharmacology Lead, you will represent Clinical Pharmacology (Clin. Pharm.) in BI projects as well as in initiatives, working groups or external platforms
    • You will provide expertise to the overall pre-clinical and clinical drug development of NCE and NBE candidates, including the design of the drug-drug interaction strategy and support of formulation development/biopharmaceutical aspects.
    • You will provide input into clinical development plans, clinical study protocols and reports, Investigator’s Brochures and the Clin. Pharm. section of INDs, CTA’s, NDAs/BLAs or respective label text.
    • You will be accountable for all ClinPharm aspects of a compound in early and late-stage clinical drug development teams as well as towards regulatory authorities worldwide.



Additional tasks & responsibilities as Senior Principal Clinical Pharmacology


  • As Senior Principal Clinical Pharmacology Lead you will additionally take a leading role in implementing and promoting innovative methodologies and approaches, and provide training and expert advice to junior colleagues and interfaces.



Requirements


  • Ph.D. in Pharmaceutical Sciences or other life sciences with
    • 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, Clinical Pharmacology trials in special populations, incl. pediatrics, PK-safety trials (ECG)
    • Thorough understanding of drug metabolism and PK/PD, including working knowledge in pharmacokinetic software programs; understanding and/or experience with modeling tools incl. PBPK is preferred
    • A solid understanding of the principles of clinical and pre-clinical drug development for NCE and NBE, ideally with experience in the area of oncology, CNS or retinal health
    • Knowledge on guidelines from the main regulatory agencies such as EMA, FDA, PMDA
    • Basic knowledge in biomarkers, pharmacogenomics and biostatistics
  • Excellent oral and written communication, negotiation and presentation skills



Additional requirements as Senior Principal Clinical Pharmacology


  • Long-standing experience in clinical pharmacology or clinical PK/PD departments within pharmaceutical industry, CROs, regulatory authorities or academic institutions
  • Distinct social and leadership skills
  • Great sense of responsibility and interest in interdisciplinary work
  • Demonstrated comprehensive knowledge of the drug development process


Recruitment process:

Step 1: Online application - application deadline is 29.03.2023
Step 2: Virtual meeting in the period from 20.03.2023 - 26.03.2023
Step 3: On-site interviews in the period from 03.04.2023 -06.04.2023


WHY BOEHRINGER INGELHEIM?


This is where you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area.

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.


READY TO CONTACT US?


Please contact our Recruiting Team, Tel: +49 (0) 6132 77-173173

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Company

With 47,700 employees in 103 countries, Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Since its foundation in 1885, the family-owned company has been pursuing an ambitious goal: to research and develop innovative pharmaceuticals that improve the health and quality of life of humans and animals alike

Company info
Website
Location
Binger Straße 173
Ingelheim am Rhein
55216
Germany

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