Associate Director, Quantitative Systems Pharmacology

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 

The Role

You will serve as the quantitative systems pharmacology (QSP) lead on 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. You 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. You will assist in providing mechanistic modelling rationale for dose regimen selection in FIH trials and beyond, and identification of circumstances where dose adjustment or patient selection/stratification should be considered. You will be responsible for all aspects of quantitative systems modelling & simulation strategies for candidate drug products from early development (pre-IND) through late stage development 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.

The level of the role will be commensurate with the individual's level of experience.

Responsibilities:

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

• Contributes expert QSP input into key pre-clinical, clinical and regulatory documents including study protocols, study reports, investigator brochures, and other documents within agreed timelines

• Develops QSP and PK/PD modelling and simulation plans to guide rational first in human dose projection and dose selection

• Works with clinical pharmacology leads to support 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 mechanistic modelling and simulation plan and interpreting results.

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

• Liaise with the Clinical Pharmacology representative on Global Clinical and Pre-Clinical Development Teams 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

Requirements:

• A PhD in Applied Mathematics, Engineering, or related discipline with 5 years or more of experience in the application of mechanistic mathematical modelling in the life sciences is required.

• Demonstrated ability and experience in apply modelling and simulation approaches to enable rational and efficient preclinical and clinical drug development are required

• Proficiency of the application of a broad range of quantitative tools including but not limited to Matlab/SimBiology, Julia, NONMEM, R and other PK/PD/QSP analysis software.

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

• 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.

Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.