Associate Director, Pharmacometrics, Clinical Pharmacology

Clinical Dynamix, Inc.; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Travel <10%

Competitive compensation

Job summary

Clinical Dynamix, Inc. is seeking an Associate Director, Pharmacometrics to design and lead modeling & simulation across late-stage programs in a fast-paced biopharma setting.

The role emphasizes MIDD approaches, PK/PD modeling, exposure–response analyses, and regulatory submissions, with NLME methods and hands-on NONMEM/R experience.

Candidates should have a PhD/PharmD and 4+ years of industry experience; travel <10% is required.

Qualifications

• PhD or PharmD in Pharmaceutical sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent) required.
• 4+ years of relevant industry experience including NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation.
• Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas.
• Experience with incorporation of MIDD strategies into drug development across all phases and responding to questions on dose and regimen justification, study design among others.
• Hands-on experience with at least NONMEM and R is strongly preferred.

Responsibilities

• Developing and executing modeling and simulation strategies from the early through late-stage clinical development and serve as the SME in cross-functional development program teams.
• Delivering strategic and well-timed modeling input at key decision points along the development path.
• Set the strategy for addressing pharmacometric issues in regulatory submissions and directly influences drug development decisions.
• Lead and drive PMX contributions to integrate relevant technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies.
• Use state of the art modeling and simulation approaches to interpret PK/PD data and accountable and responsible for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, and exposure-response analysis.
• Guide empirical modeling/QSP approaches to understand relationship between PK, biomarkers and disease outcomes undefined.

Skills

NLME methods

Dose-Exposure-Response

Population PK/PD

MIDD strategies

NONMEM

R

Clinical pharmacology

PK-PD modeling

Regulatory submissions

Data analysis & interpretation

Education

PhD/PharmD

4+ years industry experience

MIDD experience

Tools

NONMEM

R

Job description

Associate Director, Pharmacometrics, Clinical Pharmacology

Our client is seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

Position Summary:

The individual will be responsible for the design, leadership, and implementation of Modeling & Simulation strategies across our client’s clinical programs. In this role, you will perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches. You will set the strategy for addressing pharmacometric issues and directly influences drug development decisions. The successful candidate will have good quantitative pharmacology skills, scientific reasoning, exploratory graphical analysis skills and report writing skills.

Responsibilities:

• Developing and executing modeling and simulation strategies from the early through late-stage clinical development and serve as the SME in cross-functional development program teams
• Delivering strategic and well-timed modeling input at key decision points along the development path
• Set the strategy for addressing pharmacometric issues in regulatory submissions and directly influences drug development decisions
• Lead and drive PMX contributions to integrate relevant technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies
• Use state of the art modeling and simulation approaches to interpret PK/PD data and accountable and responsible for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, and exposure-response analysis
• Guide empirical modeling/QSP approaches to understand relationship between PK, biomarkers and disease outcomes undefined

Education/Experience Requirements:

• PhD or PharmD in Pharmaceutical sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent) required
• 4+ years experience of relevant industry experience including NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation
• Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas
• Experience with incorporation of MIDD strategies into drug development across all phases and responding to questions on dose and regimen justification, study design among others
• Hands-on experience with at least NONMEM and R is strongly preferred.

Additional Skills/Experience/Requirements:

• The ideal candidate will embody our client’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a small, fast-moving and entrepreneurial environment.
• Ability to manage multiple, complex tasks with competing timelines.
• Strong interpersonal, verbal, and written communication skills.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Self-motivated and can independently manage responsibilities.
• Ability to travel (<10%).