Senior/Principal Scientist Systems PBPK-QSP

Are you a 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 and toxicology(QSP/T)? 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/T business, we are looking for a Junior/Senior/Principal Scientist Systems PBPK-QSP (m/f/d) to strengthen our multi-disciplinary project teams for the successful completion of client goals. 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 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 3+ (Senior: 6+,Principal: 10+) yearsof applied (pre-)clinical pharmacology / toxicology experience (Senior: 3+, Principal: 5+)yearsof leading projects and programs (Senior:3+,Principal: 5+) yearsof experience in regulatory applications of PBPK-QSP/T modeling in pre-clinical and clinical development Good knowledge of regulatory requirements and guidelines for modeling and simulation 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 Proficiency in a scripting language for modeling and simulation (ideally R, alternatively MATLAB®) Expert knowledge in domain-specific modeling software (e.g. PK-Sim® /MoBi®, SimCyp®, or GastroPlus®, Simbiology, SBML/Tellurium/Antimony) 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 in an all-remote setting Availability for occasional travel to company meetings and conferences 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 regulatory interactions (e.g. scientific advice, MIDD, IND/NDA/BLA)submissions Advanced expertise in pharmacometric modeling software (e.g. NONMEM®,Monolix, or IQRtools) A strong understanding of statistics Therapeutic domain knowledge (e.g.: Diabetes, Oncology, Infectious diseases, Immunology or Inflammation) and knowledge about important types of novel modalities (siRNA, PROTACs, TCEs, ADCs) as well as physiology (liver, heart, lungs, T-cells, etc.) Published peer-reviewed articles What's in store for you The dynamic team behind ESQlabsunites people with different backgrounds, spanning disciplines like pharmaceutical sciences, physics, bioinformatics, mathematics, data science, and software engineering. Our trust in each other, our open-mindedness, and our constant quest for excellence and innovation unite us. We value flat hierarchies, where everyone can contribute ideas and expertise to develop the best product. We are passionate, always willing to broaden our horizons, and love our start-up culture. You will also benefit from: Flexible work hours and a home office policy that focuses on people and not on numbers An attractive remuneration package A dedicated budget for education programs and conferences you can attend A working environment in which your contribution will make a difference, and that allows you to take ownership of projects and processes Responsibility, autonomy, participation, and career perspective About us We collaborate with global corporations in the pharma and chemical industry, as well as start-ups in the life-science technology sector and academic and non-profit research institutions. We define new standards in pharmacometrics and systems pharmacology and toxicology areas. Our software and model platforms help scientists understand mechanisms of diseases and chemical toxicity to optimize individualized treatment of patients and protect the health of the animal and human life. ESQlabshas attracted international players as sponsors for the OSP Software development. In addition, funding through national and EU-wide research grants allows us to develop our core technologies continuously. For more information about our culture, values and benefits visit our Unique career opportunities - ESQlabsGmbH. At ESQlabs, we are committed to diverse backgrounds and experiences. #J-18808-Ljbffr