Merck - Associate Scientific Director - Pharmacometrics

Associate Scientific Director, Pharmacometrics (PMX)

Position Title: Associate Scientific Director, Pharmacometrics (PMX)

Your Role:

- Associate Scientific Director, Pharmacometrics (PMX) position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization will be scientific and cross-functional role, responsible for developing and executing Model Informed Drug Development (MIDD) plans and strategies from the early translational to the late-stage clinical development in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization.

- This position will participate in the Quantitative Pharmacology activities to strengthen the PMX platform capabilities by contributing to the strategic use of modeling & simulation (M&S) methodologies across disease areas, in alignment with the overall clinical development plan, aligning with the stakeholders, and executing the program strategy/plan to ensure timely deliverable.

- This position will be responsible for PMX assignments either executed internally under proper supervision or in collaboration with external PMX CROs by providing close scientific and technical supervision. The incumbent will be expected to manage multiple projects simultaneously and participate in discussions and presentations under proper supervision.

KEY ACCOUNTABILITIES:

- Prepare, execute, present, report and/or supervise modeling & simulation projects, summarize and report M&S projects in relevant regulatory submission documents (e.g. CTD 2.7.2)

- Develop and execute MIDD strategies/plans which are fully integrated with the overall clinical development plans

- Apply MIDD methodologies to contribute to decision making at critical milestones based on quantitative principles in close collaboration with partner functions (e.g. clinical pharmacology, biostatistics, data sciences, clinical development, research)

- Strengthen and build internal PMX platform capabilities (e.g. disease progression modeling, clinical trial simulations, model based meta-analysis); Promote innovation by independent research, collaboration within the company or with external partners

- Keep up-to-date with scientific advancement in PMX and share expertise with colleagues

- Represent PMX with internal and external stakeholders

Who You Are:

Minimum Qualifications:

- 5+ years (Bio)pharmaceutical industry and/or postdoctoral experiences with hands-on pharmacometrics modeling

- Doctorate degree (PhD, PharmD or MD) relevant in the related disciplines of pharmacometrics, pharmaceutics, clinical pharmacology, statistics, engineering or mathematics

- Fluency in English

Preferred Qualifications:

- Excellent knowledge and hands-on expertise in SimCYP, R and/or SAS, NONMEM and/or MONOLIX, and related pharmacometrics software

- Promote MIDD internally and externally

- Demonstrated ability for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results.

- Clear evidence of ability to adapt to changing business needs by prioritizing multiple tasks

- General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus

- Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment

- Strong presentation, communication and organization skills. Ability to communicate technical results to stakeholders.