Boehringer Ingelheim Senior Associate Director, Pharmacometrician OR Principal Pharmacometrician 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.

Senior Associate Director Description:

The Sr. AD will independently perform high quality pharmacometric (PMx) analyses on a project and study level essential for internal decision making and successful approval. They will represent PMx in project and trial teams as well as author PMx documents and develop PMx strategy, independently.

SAD Duties & Responsibilities:

  • Ensure timely delivery of state-of-the-art PMx analyses for internal decision making throughout clinical drug development and registration with support of supervisor (e.g., non-linear mixed effects models, model-based meta analyses for dose selection, labeling, optimizing clinical study designs and pediatric development)

  • Develop PMx strategy and clinical development plan, and implement model-informed drug discovery and development (MID3) in clinical development projects.

  • Ensure timely delivery of PMx internal documents (e.g., dataset specification, PMx analysis plan, and PMx report)

  • Ensure timely delivery of documents where PMx is co-author (e.g., clinical development plan, pediatric investigational plan, submission documents)

  • Represent PMx in project teams (e.g. early clinical development team and medical sub team), and regulatory meetings

  • Represent PMx in internal and external initiatives/working groups (e.g., process harmonization, IMI calls, ISoP groups)

  • Represent PMx in decision body meetings

  • Organize and manage projects with external organizations (e.g., academic institutions or CROs)

  • Continuously initiate improving the PMx IT infrastructure (e.g., specific code libraries).

  • Continuously evaluate and implement novel PMx methods and approaches.

  • Understand current national and international regulations, local requirements, BI policies and procedures as relevant to areas of expertise

  • Apply this knowledge to ensure safe and compliant practices, manage risks, and maximize opportunities for projects to succeed

SAD Requirements:

  • Master’s Degree from an accredited institution in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with a minimum of four to twelve (4-12) years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia or; MD/PhD from an accredited institution in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with minimum of two to nine (2-9) years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia

  • Proficiency in applying PMx software (e.g., NONMEM, Monolix, R, SAS, PKSim, MATLAB, SimBiology)

  • Proficient knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines

SAD Desired Skills, Experience and Abilities:

  • One to four (1-4) years relevant experience in working in clinical development teams, preferred.

Principal Description:

The Principal Pharmacometrician will act as an internally and externally recognized Pharmacometrician and/or integrator in (early) clinical development teams by developing pharmacometrics (PMx) strategy, perform PMx analyses and represent PMx and/or TMCP in project teams and regulatory meetings. They will continuously and consistently develop, implement and promote innovative PMx methodologies/approaches and provide consultancy and expert advice for other pharmacometricians.

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

Principal Duties & Responsibilities:

  • Ensure timely delivery of state-of-the-art PMx analyses for internal decision making throughout clinical drug development and registration with support of supervisor (e.g., non-linear mixed effects models, model-based meta analyses for dose selection, labeling, optimizing clinical study designs and pediatric development)

  • Develop PMx strategy and clinical development plan, and implement model-informed drug discovery and development (MID3) with focus on complex international development projects

  • Ensure timely delivery of PMx internal documents (e.g., dataset specification, PMx analysis plan, and PMx report)

  • Ensure timely delivery of documents where PMx is co-author (e.g., clinical development plan, pediatric investigational plan, submission documents)

  • Act as integrator in early clinical development teams (ECD integrator)

  • Represent Translational Medicine & Clinical Pharmacology in core teams and decision body meetings (CTM TMCP)

  • Represent PMx in project teams (e.g. early clinical development team and medical sub team), regulatory meetings

  • Lead or participate internal and external initiatives/working groups (e.g., process harmonization, IMI calls, ISoP groups)

  • Organize and manage projects with external organizations (e.g., academic institutions or CROs)

  • Establish and maintain contacts to key opinion leaders in the field of PMx.

  • Continuously initiate improving the PMx IT infrastructure (e.g., specific code libraries).

  • Develop, implement and promote (increase visibility of) innovative PMx methodologies and approaches in multiple therapeutic areas

  • Maintain and extend expertise in therapeutic area(s) by keeping abreast of new publications and evaluating their impact on the modeling environment and adjust accordingly.

  • Understand current national and international regulations, local requirements, BI policies and procedures as relevant to areas of expertise

  • Apply this knowledge to ensure safe and compliant practices, manage risks, and maximize opportunities for projects to succeed

  • Provide consultancy and expert advice for critical or complex PMx methodologies/approaches for other pharmacometricians

Principal Requirements:

  • Master’s Degree from an accredited institution in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with a minimum of seven to fifteen years (7-15) years of experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia or; MD/PhD in from an accredited institution Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or relevant area of focus with a minimum of four to nine (4-9) years of experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia.

  • Proficiency in applying PMx software (e.g., NONMEM, Monolix, R, SAS, PKSim, MATLAB, SimBiology)

  • Proficient knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines.

Desired Skills, Experience and Abilities:

  • Minimum of four (4) years relevant experience in working in clinical development teams, preferred.

EligibilityRequirements:

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

Our Culture:

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. 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.

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.

Organization: US-BI Pharma/BI USA

Title: Senior Associate Director, Pharmacometrician OR Principal Pharmacometrician

Location: Americas-United States-CT-Ridgefield

Requisition ID: 174040