Associate Director, Quantitative Pharmacology & Pharmacometrics - Mechanistic Modeling, Immunology

MSD • Boston, PA

4d • Hybrid

About The Position

The Associate Director is an expert mechanistic modeler and a quantitative drug developer who independently designs and executes model analysis plans with minimal supervision informing translational and drug development research questions within immunology. The ideal candidate is collaborative, possesses a learning mindset and effectively partners with functional departments and external vendors to develop aligned strategies and deliver solutions. In addition, you share your skills and ideas with the department to advance our science. Excellent communication skills are required including the ability to clearly present scientific data in group settings. As an Associate Director, you will participate in cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for immunologic disorders. You will apply your expertise to frame critical drug development questions to optimize drug development using model-based approaches and influence cross-functional teams to adopt such strategies. More specifically, you will apply your quantitative skills to integrate preclinical and clinical data developing and using PK/PD, PBPK, QSP, or other mechanistic models of drug disposition and drug action to define success criteria and make model-informed decisions. Moreover, you develop and implement translational PK/PD strategies, perform clinical trial simulations, conduct comparator modeling and other model-based analyses to inform dose selection and schedule, clinical trial design and go/no-go decisions.

Requirements

• Ph.D. or equivalent degree with at least 4 years of relevant experience; PharmD or equivalent degree with at least 6 years of relevant experience; or MS or equivalent degree with at least 8 years of relevant experience.
• Relevant experience should reflect increasing responsibility and independence in pharmaceutical drug development, a regulatory agency, or academia.
• An educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/ biostatistics, computational biology/chemistry, or chemical/biomedical engineering.
• Experience in performing hands-on (population) PK / PKPD / QSP modeling using standard pharmacometric software (e.g. Phoenix, R, Matlab, NONMEM, Monolix).
• Advanced skills in experimental design, mathematical problem solving, critical thinking about data analysis and interpretation.
• Proficiency in written and verbal communication and interdisciplinary collaboration.

Nice To Haves

• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches.
• Knowledge of immunology biology.
• Experience with complex therapeutic biologics.
• Expertise in developing novel modeling strategies or automated workflows that rely on PBPK, QSP or related mechanistic modeling.
• Experience in integrating AI/ML methods in mechanistic modeling and/or modeling workflows.
• Scientific understanding of ADME and biopharmaceutic properties of biologics, small molecules, or non-traditional therapeutics.

Responsibilities

• Independently designs and executes model analysis plans with minimal supervision informing translational and drug development research questions within immunology.
• Applies expertise to frame critical drug development questions to optimize drug development using model-based approaches.
• Influences cross-functional teams to adopt model-based strategies.
• Integrates preclinical and clinical data developing and using PK/PD, PBPK, QSP, or other mechanistic models of drug disposition and drug action to define success criteria and make model-informed decisions.
• Develops and implements translational PK/PD strategies.
• Performs clinical trial simulations.
• Conducts comparator modeling and other model-based analyses to inform dose selection and schedule, clinical trial design and go/no-go decisions.
• Participates in cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for immunologic disorders.
• Shares skills and ideas with the department to advance science.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays, vacation, and compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree