Associate Director, Modeling & Simulation (Pharmacology)

Princeton, New Jersey (US)
Competitive salary and benefits
May 28, 2018
Jul 28, 2018
Medical Director
Full Time

Associate Director, Modeling & Simulation (Pharmacology)

The Associate Director, Modeling & Simulation (Pharmacology) will serve as the pharmacology lead on a number of pre-clinical and clinical development programs providing pharmacology support and execution of clinical development plans that include characterization and prediction of pharmacokinetics and pharmacodynamics of the drug candidate. This individual will also work in close collaboration with scientists in Translational Research and Clinical Development to conduct quantitative PK/PD/safety/efficacy analyses for integration into overall program strategies. This person will provide rationale for dose regimen selection in FIH trials and beyond, and identification of circumstances where dose adjustment or patient selection/stratification should be considered. The person will be responsible for all aspects of quantitative modeling & simulation strategies for candidate drug products from early development (pre-IND) through late stage development (Phase 3 and BLA filings) using model-based approaches to improve the efficiency of drug development, improve our mechanistic understanding and support dose selection. This is an exciting opportunity to be part of a passionate, high profile, high-impact Pharmacology team, and work in a highly dynamic and collaborative setting

Key Accountabilities

Provides pharmacology support on multi-disciplinary study teams for pre-clinical and clinical programs

Contributes expert pharmacology input into key pre-clinical, clinical and regulatory documents including study protocols, study reports, investigator brochures, INDs, IBs, BLAs and other documents within agreed timelines

Development of PK/PD modeling and simulation to guide rational first in human dose projection and dose selection

Leads clinical pharmacology efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions. Analyzes results, interprets, and recommends action based on study results.

Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan and interpreting results.

Performs or oversees PK and PK / PD analyses using a variety of tools and approaches. Integrates, interprets and reports data to project teams and other customers.

Serve on Global Clinical and Pre-Clinical Development Teams as Pharmacology representative and provides a source of Pharmacology expertise and advice to other functions across the Company

Coordinate with clinical and translational medicine teams on strategic priorities and study support

Performs other responsibilities as requested by management

Skills & Experience

A PharmD or PhD in Clinical Pharmacology, Pharmacology, Pharmacokinetics, or related discipline with at least 5 years of experience in Clinical Pharmacology and/or pre-clinical PK is required

Experience with PK/PD, allometric scaling, analysis and translational modeling of preclinical PK/PD data, and mechanism-based PK/PD systems using preclinical and/ or clinical data with biologics therapeutics is preferred

Demonstrated ability and experience in apply modeling and simulation approaches to enable rational and efficient preclinical and/or clinical drug development are required

Proficiency of the application of a broad range of quantitative tools including but not limited to WinNonLin, Phoenix, NONMEM, R and other PK/PD analysis software.

Extensive experience and strong understanding of oncology drug development is preferred

Flexible, with positive attitude, ability to work with multidisciplinary teams, prioritize projects effectively and communicate at all levels within the company

Excellent written, verbal and interpersonal communication skills

Domestic and international travel will be required.

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