(Senior/Principal) Pharmacometrician

Boehringer Ingelheim

(Senior/Principal) Pharmacometrician

Boehringer Ingelheim

Biberach or Ingelheim, Germany

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

The positions can either be filled in Biberach or Ingelheim.
This job is posted permanently as we have a continuous demand for this profile.

The Pharmacometrics Group

Within Pharmacometrics (PMx) at Boehringer Ingelheim we apply a question-based, fit-for-purpose approach to inform drug development with state-of-the-art PMx strategies and PMx analyses that include but are not limited to population pharmacokinetics, exposure-response, disease progression modeling, model-based meta-analysis and PBPK.

We strive to implement model-informed drug development (MIDD) in projects as well as across projects and disease areas in order to optimize study designs and to inform drug development strategies, decision-making and successful approval. Our aim is to foster the quantitative understanding of diseases and pharmacological interventions in close collaboration with other disciplines.

We believe that every member of the PMx group should be empowered to shape the future of PMx at Boehringer Ingelheim by actively contributing or leading internal and external working groups focusing on e.g. PBPK, disease strategies, innovative methods, IT, standardization and processes.

Within our group we value active contributions to discussions, a culture of sharing knowledge, active feedback and a positive “how to” attitude in challenging situations.

Pharmacometrician (all levels)

As a pharmacometrician with BI you actively contribute to early and late phase clinical drug development working closely together with experts in the fields of research, medicine, clinical pharmacology, biomarker, clinical development, and statistics.

You are assigned to drug development projects approximately two years before first-in-man clinical trials and support projects until successful regulatory approval and beyond.

Tasks and responsibilities

Pharmacometrician

With the support of your supervisor you will:

  • develop the PMx strategy and contribute to the clinical development plan for clinical development projects and identify opportunities where model-informed drug development;
  • (MIDD) can advance the understanding of pharmacological activity, efficacy and safety;
  • be responsible for the planning and execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta-analysis as well as PBPK to support internal decision making and successful approval;
  • ensure the timely delivery of PMx documents (e.g., dataset specification, analysis plans, and reports) and documents where PMx is co-author (e.g., clinical development plan, pediatric investigational plan, submission documents);
  • organize and manage projects with external organizations such as academic institutions or CROs;
  • represent PMx in internal initiatives and working groups collaborating closely with other disciplines.

Additional tasks as Senior Pharmacometrician

As a senior pharmacometrician, you perform the responsibilities of the pharmacometrician independently and, additionally, you:

  • contribute to internal/external initiatives;
  • are responsible to continuously evaluate and implement novel PMx methods and approaches and may provide support and/or development of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes;
  • represent PMx in internal and external initiatives/working groups such as process harmonization, IMI calls, ISoP groups, OSP.

You will have the opportunity to act as a “CPPI” (Clinical Pharmacology and Pharmacometrics Integrator) where you, in close alignment with clinical pharmacology experts, will be accountable for:

  • representing PMx and clinical pharmacology aspects (e.g. drug-drug interactions, formulation development, food effect, absolute bioavailability) in early and late stage clinical drug development teams and authority interactions;
  • author PMx and clinical pharmacology contributions to documents such as the clinical development plan, investigators brochure, pediatric development plans;
  • the conduct of analysis regarding clinical pharmacology aspects on a trial and project level.

Additional tasks as Principal Pharmacometrician

As a Principal Pharmacometrician, you perform the responsibilities of a senior pharmacometrician and, additionally, you:

  • act as an internally and externally recognized Pharmacometrician and have the opportunity to act as the leader of Early Clinical Development Teams and Clinical Pharmacology and Biomarker Teams (“ECD integrator”/“CPBM integrator”) representing Translational Medicine and Clinical Pharmacology in core teams and decision body meetings;
  • continuously and consistently develop, implement and promote (increase visibility of) innovative PMx methodologies/approaches in multiple therapeutic areas and provide consultancy and expert advice for other pharmacometricians;
  • lead or contribute to internal and external initiatives/working groups (e.g. process harmonization, IMI calls, ISoP groups, OSP), organize and manage projects with external organizations and establish and maintain contacts to key opinion leaders in the field of PMx.

Requirements

Pharmacometrician

  • PhD, MD or Masters Degree from an accredited institution in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with first experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia, preferred;
  • Proficiency in applying PMx software (e.g., NONMEM, Monolix, R, SAS, PBPK software);
  • Basic knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory Guidelines.

Senior Pharmacometrician

  • Several years of relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia, preferred;
  • Several years of relevant experience in working in clinical development teams;
  • Proficiency in applying PMx software (e.g., NONMEM, Monolix, R, SAS, PBPK software);
  • Proficient knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines.

Principal Pharmacometrician

  • Long standing experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia, preferred;
  • Minimum of four years relevant experience in working in clinical development teams, preferred.

EFFECTS OF COVID-19

We will continue to hire talented people and we look forward to receiving your applications. As a result of COVID-19, we have introduced alternative working arrangements to ensure that our employees can stay safe and healthy, because the health of our employees is among our top priorities. At all company locations, we work remotely whenever possible. Additionally, we are now hosting virtual video interviews for applicants. During the limited in-person interviews we still have during this time, we pay special attention to distance and the hygiene rules recommended by the Robert Koch Institute. New employees who do not start on site in production or the laboratories are sent the necessary IT equipment, our Welcome Days take place online, and we plan to conduct their onboarding training virtually whenever possible.

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 EMEA Team: Melanie Hensler, Tel: +49 (7351) 54-186083.

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© EuroJobsites 2020

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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