Senior Quantitative & Clinical Pharmacology Advisor - Remote EST

Orbis Clinical is seeking a remote-based Senior Quantitative & Clinical Pharmacology Advisor for 6 months.Job Title: Senior Quantitative & Clinical Pharmacology AdvisorLocation: Remote, must be able to work EST business hours Contract: 6 monthsJob Summary:The Contract, Senior Quantitative & Clinical Pharmacology Advisor will provide experienced, hands-on technical support to the Interim Head of QCP during a defined transition period. The consultant will serve as a senior scientific advisor across selected development programs, reviewing and interpreting nonclinical and clinical pharmacology data, advising on PK/PD, pharmacometrics, dose selection, and biomarker strategy, and contributing to priority regulatory and program deliverables. The work will be performed in close collaboration with QCP colleagues and cross-functional partners; the role has no direct reports or formal team-management responsibility.Scope of Technical Support:Provide senior scientific and technical counsel to the Interim Head of QCP on priority programs and time-sensitive deliverables.Review nonclinical and clinical pharmacology data, analysis plans, outputs, reports, and presentations; identify key scientific issues and recommend practical next steps.Advise on clinical pharmacology and model-informed drug development strategies, including PK/PD, exposure-response, population PK, dose and regimen selection, and benefit-risk interpretation.Integrate ADME/DMPK, translational pharmacology, biomarker, efficacy, and safety data to support development decisions from preclinical development through registration and life-cycle management.Support the design and interpretation of nonclinical and clinical studies, including first-in-human dose selection, pivotal dose justification, special-population considerations, and alternative dosing strategies.Provide technical input to protocols, analysis plans, investigator’s brochures, briefing materials, clinical pharmacology summaries, and other regulatory submission documents.Help prepare responses to health authority questions and, as requested, participate as a QCP subject-matter expert in regulatory and cross-functional discussions.Review work performed by external vendors or consultants and provide scientific feedback to support quality and timely delivery.Partner with Clinical Development, Biometrics, Regulatory, Nonclinical, Safety, and other functions to translate quantitative findings into clear, actionable recommendations.Document key assumptions, conclusions, technical risks, and recommendations to support continuity and effective handoffs during the interim period.Experience and Qualifications:Ph.D., Pharm.D., M.D., or equivalent advanced degree in clinical pharmacology, pharmacometrics, pharmaceutical sciences, biomedical engineering, or a related discipline.Extensive biotechnology, pharmaceutical, or regulatory experience in quantitative and clinical pharmacology, with the judgment to operate independently as a senior technical advisor.Demonstrated experience applying PK/PD, population PK, exposure-response, modeling and simulation, and translational approaches to drug-development decisions.Strong knowledge of clinical pharmacology strategy, study design, dose selection, regulatory requirements, and submission expectations across development stages.Experience reviewing technical analyses and deliverables and communicating clear, scientifically rigorous recommendations to cross-functional stakeholders.Experience with rare diseases, gene therapy, RNA-based therapeutics, biologics, or other novel modalities is strongly preferred.Experience interacting with or preparing materials for global health authorities is preferred.Strong written and verbal communication skills, with the ability to convey complex technical concepts clearly to both specialist and non-specialist audiences.Ability to prioritize urgent work, collaborate effectively, and deliver high-quality outputs within a defined consulting engagement.Compensation Details:Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.The Pay Range for this position is $183.87 - $227.58 per hour, can vary depending on employment status.Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).  EEO and Reasonable Accommodation Statement:Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us. By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.