Director/Sr. Director, Clinical Pharmacology

Role Summary

Director/Senior Director, Clinical Pharmacology with experience in clinical pharmacology and pharmacometrics to develop novel biologic therapies targeting protein growth factors. The role involves leading clinical pharmacology strategies across programs, performing modeling and simulation to guide trial design and dosing, and contributing to regulatory documentation. Preference for experience in subcutaneous drug development.

Responsibilities

• Lead clinical pharmacology strategies across multiple programs at various stages of clinical development
• Execute modeling and simulation plans including PK/PD, population PK, and exposure-response analyses to guide clinical trial design, dose selection and optimization
• Develop clinical pharmacology plans to bridge IV to SC dosing
• Provide pediatric clinical pharmacology expertise and co-lead workstreams related to formulation development and sub-cutaneous route of administration
• Apply model-based drug development principles to answer key development questions enabling efficient drug development
• Contribute to preparation of regulatory documents and participate in discussions with Regulatory Agencies, with a focus on Model-informed Drug Development (MIDD)
• Contribute to clinical protocol design, study execution, data analysis, and writing clinical study reports
• Collaborate and mentor bioanalytical and translational team to develop comprehensive preclinical and clinical PK/PD strategy

Qualifications

• PhD in pharmacokinetics or pharmacology
• 7-10 years of experience in pharma/biotech industry, with proven track record of using clinical pharmacology to guide clinical trial/dosing decision
• Proficient knowledge and hands-on experience in all aspects of clinical pharmacology, including modeling and simulation of pharmacokinetic, pharmacodynamic, and efficacy relationships, including expertise with population modeling
• Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, toxicology assessing the clinical relevance
• Experience in subcutaneous drug development and IV to SC bridging is highly desired
• Strong interpersonal skills to work effectively in a team setting/matrix-type organization
• Understands the drug development process from pre-IND through BLA
• Highly organized, outcome-oriented, self-motivated performer