About Our Client:
Our client is a pioneering biopharmaceutical company dedicated to discovering and developing groundbreaking therapies that leverage the body's natural regulation of protein levels to treat a wide array of diseases. Their mission is to revolutionize patient care through the power of targeted protein modulation.
Why Join Our Client:
Our client offers a collaborative and dynamic work environment where innovation thrives. Their team is composed of passionate and talented individuals committed to making a difference in the lives of patients. They provide competitive compensation, comprehensive benefits, and opportunities for professional growth and development.
Current Opportunities:
Our client is currently seeking talented professionals to join their team in various roles, including:
- Research and Development: Scientists and researchers with expertise in drug discovery, medicinal chemistry, and biology.
- Clinical Development: Clinical pharmacologists, clinical trial managers, and regulatory affairs specialists.
- Data Science and Bioinformatics: Experts in data analysis, bioinformatics, and computational biology.
- Manufacturing and Quality: Specialists in process development, quality assurance, and regulatory compliance.
- Business and Operations: Professionals in project management, business development, and corporate operations.
Featured Position: Associate Director of Clinical Pharmacology
Position Overview:
Our client is looking for a highly skilled and motivated Associate Director to join their Clinical Pharmacology group. As an early member of this team, you will have the unique opportunity to shape the direction of their clinical pharmacology efforts across both early and late-stage programs. The ideal candidate will be proficient in developing and executing clinical pharmacology strategies, including PK/PD modeling and simulation activities such as population PK/PD modeling, physiologically-based PK (PBPK) modeling, and quantitative systems pharmacology (QSP) modeling. Your expertise will be crucial in optimizing doses, dosage regimens, and study designs through data analysis, interpretation, and presentation of findings. You will also play a key role in authoring and reviewing clinical pharmacology documents for regulatory submissions and responses.
Key Responsibilities:
- Develop clinical pharmacology development plans, timelines, and study prioritization.
- Oversee and contribute to clinical pharmacology sections of clinical study protocols, SAPs, CSRs, stand-alone PK/PD reports, and clinical development plans.
- Collaborate with multidisciplinary teams to ensure modeling and simulation methods (e.g., QSP, MBDD, PBPK) inform internal decision-making and regulatory relations.
- Foster cross-functional collaborations with Clinical Operations, Research, Bioanalysis, Biometrics, CMC, and Clinical Sciences to ensure seamless implementation of Phase I-III studies.
- Integrate PK, PD, and safety data from multiple sources to optimize dosing for patient populations across the development continuum.
- Provide input on preclinical-stage programs to enhance preclinical effectiveness and biomarker data, supporting the progression of programs into clinical development.
- Advocate for MIDD across drug discovery and development.
- Identify and apply state-of-the-art quantitative approaches to projects.
Qualifications:
- PharmD, PhD, or MS in a field related to Pharmacometrics with 5-8 years of industry or similar experience in Pharmacometrics, Clinical Pharmacology, or Quantitative Systems Pharmacology.
- Demonstrated experience in managing clinical and nonclinical PK/PD projects.
- Current knowledge of regulatory guidances, global regulations, and SOPs in clinical pharmacology studies.
- Experience in authoring and reviewing clinical pharmacology documents for regulatory submissions.
- Proficiency in modeling and simulation techniques in pharmaceutical development, including population PK/PD modeling, PBPK modeling, or QSP modeling.
- Exceptional oral and written communication skills and excellent problem-solving abilities.
- Proven ability to work efficiently in a dynamic, team-oriented environment with strong emotional intelligence (respect and empathy).
- High proficiency in using common software and data analysis packages (e.g., R, WinNonlin, Simcyp, GastroPlus, Monolix, NONMEM).
