SR AD / Director, Pharmacometrics (Remote)

BioCT Innovation Commons; Connecticut; Remote; USD 140,000 - 222,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks a Sr. Associate Director/Director in Pharmacometrics to perform high-quality analyses essential for project decision-making. The role requires strong leadership ability, excellent data analysis skills, and collaboration in a global setting, with a competitive salary and benefits package provided.

Qualifications

• Six+ years relevant experience in Pharmacometrics required.
• Proficient in PMx software applications.
• Strong knowledge in clinical pharmacology and drug development.

Responsibilities

• Develop PMx strategy for drug discovery and development.
• Ensure delivery of PMx analysis and documentation.
• Represent Clinical Pharmacology/PMx on project teams.

Skills

Data Analysis

Pharmacometric Software

Team Collaboration

Interpersonal Skills

Regulatory Knowledge

Education

Master’s Degree in Pharmacometrics or related field

PhD in Pharmacometrics or related field

Professional degree in pharmacy or medicine

Tools

NONMEM

Monolix

R

SAS

PBPK software

Job description

Description

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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Are you passionate about applying your pharmacometric skills, strategic thinking, and practical experience in data analysis? Would you like to join cross-functional clinical development teams, and do you feel like expanding your influence and deepening your knowledge in pharmacometric approaches?

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

Duties & Responsibilities

• Develops PMx strategy and contribute to the clinical development plan and implement model-informed drug discovery and development (MID3) in clinical development projects with limited support of supervisor
• Ensures timely delivery of state-of-the-art PMx analyses for internal decision making throughout clinical drug development and registration (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 (e.g., dataset specification, PMx analysis plan, and PMx report)
• Ensures timely delivery of documents where PMx is co-author (e.g., clinical development plan, pediatric investigational plan, submission documents)
• Represents TMCP Clinical Pharmacology/PMx in clinical development teams, initiatives and working groups (both internal and external) such as focus groups in your therapeutic area of expertise, across department initiatives, process harmonization, IMI calls, ISoP groups, Open Systems Pharmacology.
• Organizes and manages projects with external organizations (e.g., academic institutions or CROs)
• 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

Additional tasks for the Director role:

• The Director Pharmacometrics is expected to perform the responsibilities listed for the Sr. AD level fully independently.
• Continuously evaluate and implement novel pharmacometric approaches and may support or drive the development of quantitative methodological approaches, pharmacometrics (software) tools, and related business processes.

Requirements

• Master’s Degree in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics, or equivalent area of focus with a minimum of six (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 four (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 five (5) years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia.

• Two to four (2-4) 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
• Strong team player, who is able to successfully act in the global context
• Good interpersonal skills with the ability to interact effectively with people, internally and externally

Additional requirements for the Director role:

• Seven (7) + years relevant experience in Pharmacometrics in the pharmaceutical industry, CROs, regulatory agencies, or academia
• Five (5) + years of relevant experience in working in clinical development teams (preferred)
• Broad knowledge in applying PMx software and approaches
• Broad knowledge in other data science fields, clinical pharmacology, clinical drug development, MID3, and regulatory guidelines

Compensation:

This position, Sr. AD, Pharmacometrics, offers a base salary typically between $140,000.00 and $222,000.00. 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.

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.