Remote Clinical Pharmacology and Pharmacometrics Lead
at Sia Partners

Summary

Join our team as a Clinical Pharmacology and Pharmacometrics Lead to lead the development of computational approaches for high-priority project development efforts at the Institute. As a contractor, you will work with project teams to implement and communicate model-informed drug development strategies, enabling and accelerating internal decisions.

Requirements

• PhD  in engineering, math, computer science, pharmaceutical sciences or a related quantitative field
• Minimum of 10 years experience working in a quantitative discipline, with demonstrated impact in PK-PD, QSP, PBPK, disease progression, DMPK modeling
• Advanced/Proficient high performance computing skills
• Excellent communication and written skills, distilling complex technical ideas clearly and succinctly to a diverse audience
• Ability to multi-task and manage through competing priorities in a fast-paced environment
• Strong interpersonal, communication, organizational, administrative and customer service skills
• Ability to work independently and collaborate within a team environment
• Strong attention to detail and high sense of urgency
• Demonstrated ability of leveraging self-initiative to get results
• Strong analytical, organizational and auditing skills required
• Demonstrated passion for the Gates MRI’s values with a commitment to deliver results against our mission
• Expertise in developing and applying PK, PBPB, and PKPD models using software such as Matlab, R, NONMEM, Monolix, SimCYP, PK-SIM, GastroPlus, Phoenix, and R-Stan
• Experienced in designing, implementing, and maintaining a GXP-validated high-performance pharmacometrics scientific computational environment
• Experienced in compiling and optimizing diverse data sets from both clinical and non-clinical sources to enhance Model-Informed Drug Development (MIDD) efficiency

Responsibilities

• Provide strategic leadership in Clinical Pharmacology and Pharmacometrics for both late-stage and early-stage assets, particularly in infectious diseases with focus on Tuberculosis and Malaria
• Develop advanced models of drug exposure, exposure-biomarker response, and disease progression to facilitate informed drug development decisions
• Collaborate extensively with internal and external stakeholders across various therapeutic areas, offering expertise in modeling, data science, visualization, and data analytics
• Act as a Study Director and Clinical PK Scientist for infectious diseases programs
• Contribute to regulatory documents related to Clinical Pharmacology, draft sections for clinical development plans, and engage in regulatory interactions
• Assess the feasibility of clinical studies, providing critical input on the design and review of clinical protocols
• Execute and manage Pharmacometrics and Modeling & Simulation (M&S) plans, interpreting and reporting results to support clinical development milestones
• Integrate data from various compounds across development programs to inform strategic portfolio decisions
• Represent the department in cross-functional teams, proactively addressing development opportunities
• Lead cross-functional teams covering multiple assets, mentor junior Clinical Pharmacology scientists, and promote a culture of scientific excellence and innovation
• Handle both small molecules and biologics programs effectively
• Support project milestones in discovery and development phases using mathematical modeling and simulation tools, including PK/PK-PD, drug-drug interaction evaluation, PBPK-based dose/exposure scaling, QSP, and formulation/PK assessment
• Demonstrate proficiency in Model-Informed Drug Development (MIDD), applying principles to ensure clear and timely communication of modeling results, thereby enhancing decision-making
• Utilize advanced data analysis techniques and develop algorithms to detect patterns and associations in data, leveraging diverse datasets to inform models relevant to disease biology

Benefits

• Statutory Time Off – Sick
• Medical, Dental, Vision: Eligible for Purchase Option
• 401(k) Participation: Eligible after one month of employment with matching and 100% vesting first day of participation