Director/Senior Director Pharmacometrics

Allucent

Join the A-team!

We are looking for experienced pharmacometricians to join our global pharmacometrics team at Allucent. You will join one of the industry-leading clinical pharmacology modeling simulation departments in the consultancy/CRO sector. Join a team of over 65 industry experts in pharmacometrics, translational modeling, clinical pharmacology strategy, PK analysis and data programming. Together with our legacy company, Nuventra, we have over 15 years of consultancy experience and serve over 100 clients in the biotech, mid & Big Pharma, covering all therapeutic areas, modalities and drug development phases. Apply the principles of model-informed drug development (MIDD) across the latest drug modalities, including gene therapies, bi-specifics, antibody drug conjugates, as well as established small molecules and biologics from pre-clinical through to filing and beyond. Be part of dynamic project teams with our clinical, regulatory, operations and statistical colleagues to design and deliver clinical programs and studies to our clients.

Location: United States (Remote)

Summary:

As a Director/Senior Director of pharmacometrics, you will be the project lead and senior technical modeler on multiple projects. You will be an industry veteran, (8-10 years as director, 10+ as senior director) either from pharma or consultancy, with demonstrable hands-on experience in delivering pharmacometrics analysis in a clinical setting. You will be an expert in population Pharmacokinetic and Pharmacokinetic/Pharmacodynamics modeling and have mastered the industry technical software including NONMEM and R. You will have a passion for solving drug development problems using pharmacometrics. You will have excellent verbal and written communication skills and experience in writing regulatory reports and submission documents for INDs, CTAs and ideally, BLA/MAA submissions. You will have mentored a junior pharmacometrician, from a technical and holistic perspective.

Requirements

The essential requirements for the role are:

Higher degree in life science, medicine, biomathematics/engineering/statistics

Min 8 (10+ for senior) years experience as a pharmacometrician in clinical development

Demonstrable hands-on experience in population PK, exposure-response, and PK/PD modeling in a clinical setting

Solid understanding of the principles of model-informed drug development (MIDD) and its practical delivery.

Excellent technical and programming skills with population analysis and other software, including NONMEM and R as a minimum. Experience with Monolix and PKSim is a plus.

Excellent verbal and written communication skills in English

Regulatory experience including regulatory report writing essential. Experience with regulatory submissions including INDs, CTAs, regulatory meetings and NDA/BLA/MAA submissions.

Experience in collaborating in and leading matrix teams including junior modelers, programmers and other technical and project management staff.

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