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 and lead our global PBPK/QSP business, we are looking for a Director/Lead Systems Pharmacology (m/f/d) to lead multi-disciplinary project teams through 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.
- Lead and collaborate with multi-disciplinary teams to implement quantitative clinical pharmacology projects/programs and to provide clinical pharmacology and PBPK/QSP consultation to other company projects/programs
- Build and manage a dedicated high-performing team of scientists
- Support clinical pharmacology-related components of clinical study protocols, study conduct, data analysis, and report writing with the support of colleagues
- Support project teams by providing 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
- 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
- Provide sophisticated written interpretation of material and integrate research findings into project/program methodology and results
- Provide mentoring and feedback to junior scientists
- Engage in cross-divisional discussions of scientific strategy
- Provide guidance regarding proposed approaches to addressing drug development and regulatory approval challenges
- Participate in regulatory interactions with health authorities
- Stay current with pharmacometrics and (quantitative) clinical pharmacology literature and project/program-related literature
- 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
- 10+ years of applied (pre-)clinical pharmacology experience
- 5+ years of leading projects, programs, and cross-functional teams preferred
- 5+ years of experience in regulatory applications of PBPK modeling in pre-clinical and clinical development
- Profound knowledge of regulatory requirements and guidelines for PBPK and PD (QSP)
- Experience in (IND/NDA) submissions
- 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
- Advanced expertise 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
- 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
- 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
What's in store for you
The dynamic team behind esqLABS unites 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 with stock options, bonus potential, and more!
- 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
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.
esqLABS has 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 - esqLABS GmbH.
At esqLABS, we are committed to diverse backgrounds and experiences.