Associate Director, Translational PKPD Modeling & DMPK

Our client, a global biopharmaceutical company focusing on the research, development, and manufacturing of pharmaceutical products is searching for an Associate Director of Translational PKPD Modelling and DMPK. As a senior Translational PKPD Modeling and Simulation scientist, you will have the opportunity to drive strategy and provide global leadership in PKPD science across our diverse portfolio. Your day-to-day role is to provide projects with expert modeling input into exploring the PK/PD/Efficacy in pre-clinical models and using these models to iteratively build an understanding of the dose & schedule requirements for therapeutic intervention across different patient populations as a single agent and combined with other agents.

Job Responsibilities:

• Representing Oncology DMPK and providing overall scientific leadership for cross functional and external collaborations involving DMPK.
• Exploring the effects on target and pathway to understand the requirements for efficacy and set a candidate drug target profile (CDTP).
• Predicting human dose and regimen together with providing input into exposure and pharmacodynamic (PD) biomarker based decision criteria for early clinical trials.
• Driving learning through back translation of early clinical exposure and PD data and providing prioritized future options for clinical testing.
• Leading and participating in Oncology strategic scientific initiatives and continuous improvement projects by providing expert M&S knowledge.
• Having a breadth of influence and impact across DMPK and externally within their discipline.
• Identifying, championing and developing new ideas.
• Leading scientific discipline networks and acting as a focus for debate within the scientific community.
• Advising on and participating in the development of Discovery or Development strategies in PKPD for biologics/ADCs/small molecules.
• Managing student and Post Doc programmes.
• Leading external collaborative projects with academic or cross-pharma pre-competitive groups.
• Providing disciplinary scientific leadership and presenting work through patents, publications and lectures.

Skills and Requirements:

• PhD or equivalent degree in a discipline with a significant component of Modeling & Simulation, such as systems biology, quantitative pharmacology, pharmacometrics, chemical engineering, physics, pharmaceutical sciences or applied mathematics.
• At least 7+ years of relevant industry experience in Modeling & Simulation, ideally in preclinical/translational setting, or a MS degree with at least 10+ years of relevant industry experience.
• Experience in a project-facing role at pharmaceutical R&D.
• Comprehensive understanding of DMPK and pharmacology/safety aspects of drug discovery and development with a strong publication record.
• Track record of supporting PK, PKPD and TKPD aspects of projects, with a delivery focus and ability to meet timelines to pre-specified quality and cost.
• Specialist in tools such as WinNonLin/Phoenix NLME, NonMem, Berkeley Madonna, MATLAB, and SimCYP.
• Excellent interpersonal and communication skills.
• Strong influence and leadership skills.
• Experience in providing modeling support for other modalities in addition to small molecules is a plus.

If you are having difficulty in applying or if you have any questions, please contact Natasha Patel at (+1) 617-778-7319 or n.patel@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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