Job Description

Description:

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

**Selected candidate will be hired into the level of role commensurate to their experiences, education, and/or business needs***

The position will be filled in Ridgefield, CT, with possibility for remote working.
 

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.

As a pharmacometrician at 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.

Duties and responsibilities\:

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.

Associate Director, Pharmacometrics

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.

Senior Associate Director, Pharmacometrician

As a Senior Associate Director, Pharmacometrics, you perform the responsibilities of the Associate Director, Pharmacometrics, 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 Director, Pharmacometrics

As a Director, Pharmacometrics, you perform the responsibilities of a Senior Associate Director, Pharmacometrics, 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\:

Associate Director, Pharmacometrics

• Masters Degree in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with a minimum of 4 years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia; OR PhD in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with minimum of 2 years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia; OR Professional degree in pharmacy or medicine (e.g., PharmD, MD, Apotheker, Arzt) with a minimum of 3 years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia
• Demonstrated hands-on proficiency in highly specialized PMx software packages (e.g., NONMEM, Monolix, R, SAS, PBPK software)
• Basic knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines

Senior Associate Director, Pharmacometrics

• Masters Degree in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with a minimum of 6 years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia; OR PhD in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with minimum of 4 years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia; OR Professional degree in pharmacy or medicine (e.g., PharmD, MD, Apotheker, Arzt) with a minimum of 5 years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia
• Demonstrated hands-on proficiency in highly specialized PMx software packages (e.g., NONMEM, Monolix, R, SAS, PBPK software)
• Comprehensive knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines
• 1-4 years relevant experience in working in clinical development teams, preferred

Director, Pharmacometrics

• Master’s degree in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with a minimum of 8 years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia; OR PhD in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with a minimum of 6 years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia; OR Professional degree in pharmacy or medicine (e.g., PharmD, MD, Apotheker, Arzt) with a minimum of 7  years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia
• Internationally recognized expert in highly specialized PMx software packages (e.g., NONMEM, Monolix, R, SAS, PBPK software)
• Comprehensive knowledge in clinical pharmacology, clinical drug development, and regulatory guidelines
• Expert knowledge in application of MID3
• Minimum of 4 years relevant experience in working in clinical development teams, preferred

Eligibility Requirements\:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older
• This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click  and join us in our effort to make more health.

   

  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 a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

   

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