Boehringer Ingelheim Senior Associate Director, Pharmacometrics in RIDGEFIELD, Connecticut
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.
The Sr. Associate Director will perform high quality pharmacometric (PMx) analyses on a project and study level essential for internal decision making and successful approval with the support of their supervisor. They will represent PMx in project and trial teams as well as author PMx documents and develop PMx strategy with the support of their supervisor.
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. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Ensure timelydelivery of state-of-the-art PMx analyses for internal decision makingthroughout clinical drug development and registration (e.g., non-linear mixed effectsmodels, model-based meta-analyses for dose selection, labeling, optimizingclinical study designs and pediatric development)
Develop PMx strategyand clinical development plan, and implement model-informed drug discovery anddevelopment (MID3) in clinical development projects.
Ensure timelydelivery of PMx internal documents (e.g., dataset specification, PMx analysisplan, and PMx report).
Ensure timely deliveryof documents where PMx is co-author (e.g., clinical development plan, pediatricinvestigational plan, submission documents)
Represent PMx inproject teams (e.g. early clinical development team and medical sub team), andregulatory meetings.
Represent PMx ininternal and external initiatives/working groups (e.g., process harmonization,IMI calls, ISoP groups).
Represent PMx indecision body meetings
Organize and manageprojects with external organizations (e.g., academic institutions or CROs)
Continuouslyinitiate improving the PMx IT infrastructure (e.g., specific code libraries).
Continuouslyevaluate and implement novel PMx methods and approaches.
Understand currentnational and international regulations, local requirements, BI policies andprocedures as relevant to areas of expertise
Apply this knowledgeto ensure safe and compliant practices, manage risks, and maximizeopportunities for projects to succeed
PhD from anaccredited in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy,Mathematics, Biology, Statistics or equivalent area of focus with two to nine (2-9)years of relevant experience in Pharmacometrics in the pharmaceutical industry,regulatory agencies, or academia OR; Master’sDegree from an accredited institution in Medicine, Pharmacometrics, ClinicalPharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area offocus with a minimum of four to twelve (4-12) years relevant experience inPharmacometrics in the pharmaceutical industry, regulatory agencies, oracademia OR; Professional degree from an accredited institution in pharmacy ormedicine (e.g., PharmD, MD, Apotheker, Arzt) with a minimum of four to twelve (4-12)years relevant experience in Pharmacometrics in the pharmaceutical industry,regulatory agencies, or academia. Individuals with both a Master’s degree and aProfessional degree (as outlined above) will be considered with two to nine(2-9) years of experience (also as outlined above).
Proficiency inapplying PMx software (e.g., NONMEM, Monolix, R, SAS, PKSim, MATLAB,SimBiology)
Basic knowledge inclinical pharmacology, clinical drug development, MID3, and regulatoryguidelines
One to four (1-4)years of relevant experience in working in clinical teams is preferred.
Must be legallyauthorized to work in the United States without restriction.
Must be willing totake a drug test and post-offer physical (if required)
Must be 18 years ofage or older
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. 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 are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com at http://www.boehringer-ingelheim.com/ and join us in our effort to make more health.
Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Organization: US-BI Pharma/BI USA
Title: Senior Associate Director, Pharmacometrics
Requisition ID: 1814510