Associate Director of Pharmacometrics, Quantitative Pharmacology & Pharmacometrics (Remote)

Hispanic Alliance for Career Enhancement; West Point (AL); Remote; USD 153,000 - 243,000; Full time

Job summary

An established industry player is seeking an Associate Director to lead pharmacometrics efforts in drug discovery and development. This role involves applying advanced modeling techniques to enhance decision-making and drive pipeline impact across various therapeutic areas. The successful candidate will work independently, collaborate with scientists, and contribute to regulatory submissions, ensuring compliance with global standards. This is an exciting opportunity to influence drug development strategies and be part of a team that is at the forefront of innovative modeling approaches. If you have a strong background in pharmacometrics and a passion for improving patient outcomes, this position is for you.

Benefits

Bonus eligibility

Health care benefits

Retirement benefits

Paid holidays

Vacation

Sick days

Qualifications

• Ph.D. with 3+ years, PharmD with 5+ years, or MS with 7+ years in drug development.
• Experience in pharmacometrics analyses and knowledge of drug development principles.

Responsibilities

• Implement novel quantitative approaches to improve drug development processes.
• Develop and execute population pharmacokinetic models and other analyses.
• Author regulatory documents and represent the team at meetings.

Skills

Population Pharmacokinetics (popPK)

PK/PD Models

Exposure Response (ER) Models

Model-Based Meta Analysis (MBMA)

Clinical Trial Simulations (CTS)

Disease Progression Modeling

Experimental Design

Mathematical Problem Solving

Data Analysis/Interpretation

Statistics

Education

Ph.D. or equivalent degree

PharmD or equivalent degree

MS or equivalent degree

Educational background in pharmacometrics or related field

Tools

R

NONMEM

Monolix

Matlab

Job description

Job Description
Associate Director - Pharmacometrics, Quantitative Pharmacology and Pharmacometrics
The Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced leadership team, deep modeling expertise and state-of-the-art modeling approaches across multiple therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management. The team is externally visible and continues to be at the leading edge of building innovative state of the art tools. With MIDD as an essential component of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.
This Associate Director will work with scientists within QP2 by applying one or more of the following pharmacometrics capabilities such as population pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs and thereby strengthening our pharmacometric capabilities on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author strategic documents.
Responsibilities:

1. Responsible for achieving results on major program drivers by implementation of one or more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions.
2. Framing critical drug development questions for optimizing model-informed development.
3. Responsible for developing and executing population pharmacokinetic models, PK/PD models, ER models, MBMA, CTS, disease progression models, and other pharmacometric analyses.
4. Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings.

Required Experience:

1. (a Ph.D. or equivalent degree with a minimum 3 years of experience) OR (a PharmD or equivalent degree with at least 5 years of experience) OR (an MS or equivalent degree with at least 7 years of experience), where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.
2. Educational background in pharmacometrics, biopharmaceutics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
3. Proficiency in performing pharmacometrics analyses such as population PK, PKPD, ER, MBMA, CTS, etc.
4. Knowledge of drug development, pharmacokinetics and pharmacology principles required.

Preferred Experience:

1. Proficiency in standard pharmacometric software (e.g. R, NONMEM, Monolix, Matlab, etc.)
2. Strong skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
3. Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.
4. Good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise.

This (remote) position is only applicable for those that are not within commutable distance to primary sites noted in posting.

Expected US salary range:
$153,800.00 - $242,200.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.

Employee Status:
Regular
VISA Sponsorship:
Yes
Travel Requirements:
10%