Description

This is a multi-level posting. Candidates will be hired in at the level commensurate with their education, experience and business need.

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 several 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.

The Senior Associate Director/Associate Director, Pharmacometrics will independently perform high quality pharmacometrics (PMx) analyses on a project and study level essential for internal decision making and successful approval. The incumbent will represent PMx in project and trial teams as well as author PMx documents and develop PMx strategy.

Duties & Responsibilities

Associate Director:

• Develops PMx strategy and contribute to the clinical development plan and implement model-informed drug discovery and development (MID3) in clinical development projects with support of supervisor.

• Ensures 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).

• Ensures timely delivery of PMx internal documents with support of supervisor. (e.g., dataset specification, PMx analysis plan, and PMx report).

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

• Represents PMx in clinical development teams and in initiatives and working groups with support of supervisor (e.g., process harmonization).

• Organizes and manages projects with external organizations with support of supervisor (e.g., academic institutions or CROs).

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

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

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

• Assumes responsibility for direct reports as needed including recruiting and managing; Mentors and develops scientific staff; Directs and oversees analyses and results of junior level scientists.

Senior Associate Director:

• The duties and responsibilities listed above are for the Associate Director level. The Senior Associate Director will have the same responsibilities but more independently.

Requirements

Associate Director:

• PhD in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics, or equivalent area of focus with a minimum of two (2) years OR Master’s Degree in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics, or equivalent area of focus with a minimum of four (4) years OR Professional degree in pharmacy or medicine (e.g., PharmD, MD, Apotheker, Arzt) with a minimum of three (3) years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia.

• 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 Associate Director:

• PhD in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics, or equivalent area of focus with minimum of four (4) years OR Master’s Degree in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics, or equivalent area of focus with a minimum of six (6) years OR Professional degree in pharmacy or medicine (e.g., PharmD, MD, Apotheker, Arzt) with a minimum of five (5) years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia.

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

• 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

Compensation:

 This position, Associate Director, offers a base salary typically between $135,000.00 and $232,000.00.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)

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.

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.