Senior/Principal Scientist Systems Pharmacology

esqLABS

Home Office in the EU

Are you a highly talented and motivated life-science modelling & simulation scientist with experience in the pharma industry? Do you enjoy driving innovation and setting new boundaries in physiologically-based (PBPK) modelling, pharmacokinetics, & quantitative systems pharmacology (QSP)? This position offers you this and more exciting work in an innovative and fast-paced environment.

esqLABS is an innovative, internationally acting Contract Research Organization and a global leader in the development and application of the OSP Suite (www.open-systems-pharmacology.org). We are a research-focused provider of specialized computational analyses in the life sciences industry.

To help us grow our global PBPK/QSP business, we are looking for a Senior Scientist Systems Pharmacology (m/f/d) to strengthen our multi-disciplinary project teams for the successful completion of client goals. This role will engage in activities ranging from consultations on study design and regulatory requirements through the development and evaluation of models, the performance of simulations, and the presentation of results.

Role

Complement a dedicated high-performing team of scientists
Collaborate with colleagues on multi-disciplinary teams to implement quantitative clinical pharmacology projects/programs and to provide clinical pharmacology and PBPK/QSP consultation to other company projects/programs
Provide clinical pharmacology and pharmacometric consulting through advanced PBPK/PD, QSP, and exposure-response modeling and simulation using the OSP-Suite (PK-Sim, MoBi, R), or other tools
Support clinical pharmacology-related components of clinical study protocols, study conduct, data analysis, and report writing with the support of colleagues
Responsible for appropriateness of methods, integrity of data used for analysis, and accuracy of results
Regularly engage with clients regarding the strategic approach, project execution, presentation of results, regulatory implications, and messaging of findings
Prepare final technical reports, synopses, executive summaries, and other regulatory documents
Ensure the provision of advanced literature searches for project/program-related information
Provide sophisticated written interpretation of material and integrate research findings into project/program methodology and results
Share findings with internal and external project teams; prepare abstracts, presentations, and publication-ready manuscripts
Provide mentoring and feedback to junior scientists
Integrate knowledge of PBPK, PK/PD, and QSP to provide guidance regarding proposed approaches to addressing drug development and regulatory approval challenges
Expand scientific expertise through attendance and presentation at international, national, and regional scientific conferences, client meetings, and government meetings
Develop and teach at OSP-Suite (PK-Sim, MoBi, R), and other workshops and courses

Required skills & experience

5+ years (Principal 10+ years) of applied (pre-)clinical pharmacology experience
3+ years (Principal 5+ years) of leading projects and programs
3+ years (Principal 5+ years) of experience in regulatory applications of PBPK modeling in pre-clinical and clinical development
Good knowledge of regulatory requirements and guidelines for PBPK and PD (QSP)
Strong experience presenting scientific results to professional audiences
Extensive experience preparing, submitting, and receiving approval for publications in scientific journals
Mechanistic physiologically based pharmacokinetic modeling and simulation experience
Expert knowledge in domain-specific modeling software (e.g. PK-Sim® / MoBi®, SimCyp®, or GastroPlus®)
Excellent communication, presentation, and leadership skills
Relationship-building skills with the ability to work closely with project leaders and team members
Strong organization skills and ability to handle multiple tasks simultaneously
Work well handling tight deadlines
Great critical-thinking and problem-solving skills
Fluency in English (oral and written), German is a plus

Education

PhD, or masters in quantitative sciences (Bioengineering, Applied Math, ...) with advanced (pre)clinical pharmacology related training
Or PharmD or PhD in pharmacokinetics, clinical pharmacology, or related field with advanced applied mathematics related training
Further qualities that will put you in the spotlight
Experience in (IND/NDA) submissions
Advanced expertise in pharmacometric modeling software (e.g. NONMEM®, Monolix, or IQRtools)
Proficiency in a scripting language for modeling and simulation (ideally R, alternatively MATLAB®)
A strong understanding of statistics
Therapeutic domain knowledge: Diabetes, Oncology, Immunology or Inflammation
Published peer-reviewed articles

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