Scientific Director, Pharmacometrics

EMD Serono, Inc.; Billerica (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Director of Pharmacometrics to lead Model Informed Drug Development strategies. This role involves collaborating with cross-functional teams to enhance pharmacometrics capabilities and ensure high-quality deliverables for clinical development. The ideal candidate will have a PhD in a relevant field and extensive experience in pharmacometrics modeling. Join this innovative organization to drive impactful decisions in drug development and contribute to advancing healthcare solutions. If you're passionate about quantitative decision-making and thrive in a collaborative environment, this opportunity is for you.

Qualifications

• 5+ years in pharmaceutical industry with hands-on pharmacometrics experience.
• PhD in pharmacometrics or related field is required.

Responsibilities

• Develop and execute MIDD strategies integrated with clinical development plans.
• Supervise modeling & simulation projects and report pharmacometrics content.

Skills

Pharmacometric Modeling

MIDD Principles

Clinical Trial Simulations

Bayesian Methodologies

Statistical Analysis

Machine Learning

Education

PhD in Pharmacometrics

PhD in Clinical Pharmacology

PhD in Statistics

Tools

NONMEM

R

MONOLIX

SAS

Python

Job description

Work Location: Billerica, Massachusetts
Shift: No
Department: HC-RD-BQ4 Pharmacometrics
Recruiter: Sarah Ellis

This information is for internals only. Please do not share outside of the organization.

Your Role

The role of Director, Pharmacometrics, in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization, will be a scientific and cross-functional role, responsible for developing and executing Model Informed Drug Development (MIDD) plans and strategies from early translational to late-stage clinical development in cross-functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Translational Quantitative Pharmacology, Biostatistics, Data Sciences, Patient-Focused Real-World Evidence, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization.

In this role, you will participate in activities to strengthen pharmacometrics platform capabilities by contributing to the strategic use of modeling & simulation (M&S) methodologies across disease areas, in alignment with the clinical development plan. There will be close engagement with all key stakeholders to ensure timely and high-quality pharmacometrics deliverables for the program.

You will be responsible for pharmacometrics activities executed internally or in collaboration with external CROs and will provide close scientific and technical supervision. You will also be expected to independently manage multiple projects simultaneously and participate in discussions and presentations.

KEY ACCOUNTABILITIES

• Prepare, execute, present, report and/or supervise modeling & simulation projects, and being responsible for summarizing and reporting pharmacometrics content in relevant regulatory submission documents (e.g., HA Briefing Documents, CTD 2.7.2)
• Develop and execute MIDD strategies/plans which are fully integrated with the overall clinical development plan
• Apply MIDD methodologies to contribute to decision making at critical milestones based on quantitative principles in close collaboration with partner functions (e.g. clinical pharmacology, biostatistics, data sciences, clinical development, research)
• Practice and promote quantitative decision-making by leveraging the totality of evidence approach and enable the integration of all relevant data within and outside the development program (including literature and competitor data, and Real World data) using state-of-the-art disease models, clinical trial simulations and Bayesian probabilistic frameworks to enhance clinical trial design and inform assessment of probability of success
• Collaborate with Translational QP to appropriately transition Quantitative Systems Pharmacology models developed in Research and preclinical development to population PK/PD M&S frameworks that preserve adequate mechanistic resolution for applications in clinical development
• Stay up-to-date with scientific advancements in pharmacometrics and share expertise with colleagues

Who You Are

Minimum Qualifications:

• PhD in pharmacometrics or a related disciple (e.g. clinical pharmacology, statistics, engineering, mathematics)
• 5+ years of pharmaceutical industry experience with hands-on pharmacometrics modeling and application of MIDD principles in a drug-development setting
• Position requires both domestic and international travel up to 15% of time

Preferred Qualifications:

• Excellent knowledge of and experience in application of population PK/PD models, exposure-response models, disease progression models, clinical trial simulations, Bayesian methodologies, and model-based meta-analyses to drive MIDD
• Thorough understanding of global regulatory guidelines relevant to MIDD (e.g., Population PK, exposure-response, pediatric extrapolation)
• Ability to translate highly mechanistic systems models to population PK/PD frameworks in clinical development
• Experience in pharmacostatistical modeling methods and sound understanding of the principles of statistics including Bayesian methodologies as applicable for advanced pharmacometrics modeling and clinical trial simulations
• Knowledge of emerging areas of pharmacometrics including applications of machine learning/ artificial intelligence for model-informed precision medicine development
• Experience with model-informed development of both small molecules and biologics and across all phases of clinical development is required
• Good command of NONMEM and R is an absolute prerequisite. Experience with other tools (e.g., MONOLIX, PsN, Xpose, SAS, Stan, Python, MATLAB and Simcyp) is desired
• General knowledge of oncology, neurology and/or immunology, is desirable

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.