Director/Sr. Director, Clinical Pharmacology

Summary of Position:
Director/Senior Director of Clinical Pharmacology (reports to Head of Clinical Pharmacology) to lead quantitative clinical pharmacology and pharmacometrics efforts for biologic therapies targeting protein growth factors in the disease microenvironment; responsible for PK/PD/efficacy analysis to guide development of biologics (including monoclonal antibodies).

Position Responsibilities:
- Lead clinical pharmacology strategies across multiple programs/stages
- Execute modeling & simulation (PK/PD, population PK, exposure-response) to inform trial design, dose selection, and optimization
- Develop IV to SC transition dosing plans
- Provide pediatric clinical pharmacology expertise; co-lead formulation and sub-cutaneous route workstreams
- Apply model-based drug development to answer key development questions
- Prepare regulatory documents and participate in Regulatory Agency discussions, focused on MIDD
- Support clinical protocol design, study execution, data analysis, and clinical study report writing
- Collaborate with and mentor bioanalytical/translational teams to develop preclinical/clinical PK/PD strategy

Candidate Requirements:
- PhD in pharmacokinetics or pharmacology
- 7–10 years pharma/biotech experience; track record using clinical pharmacology for trial/dosing decisions
- Strong quantitative drug development background and cross-functional/vendor collaboration
- Expertise in PK/PD and exposure-response modeling & simulation, including population modeling
- Ability to interpret/integrate complex multi-disciplinary data (pharmacology, DMPK, toxicology)
- Strong writing and presentation skills; team-oriented
- Knowledge of pre-IND through BLA drug development process
- Highly organized, self-motivated

Compensation:
$225,000 – $315,000 per year