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As a Director of Clinical Pharmacology, you will be responsible for planning, managing and delivering the clinical pharmacology strategy through execution of pharmacokinetics (PK), pharmacodynamics (PD), PK-PD modeling and pharmacometrics modules for clinical stage asset(s) in our pipeline. You will work directly with external collaborators (CROs and consultants) and with internal cross-functional leads (clinical development, clinical operations, biometrics, regulatory and quality) to help with clinical study designs, workflows and regulatory filings. Your role will be essential in expanding the Clinical Pharmacology team's capabilities in-house, offering significant opportunities for professional growth.
Job Responsibility:
Primarily spearhead and execute the clinical pharmacology strategy beginning in pre-phase 1/2 and through pivotal studies and approvals
Contribute as clinical pharmacology lead for establishing clinical proof-of-concept (PoC), dosing recommendations, clinical study design/execution documents and regulatory filings by working cross-functionally primarily with clinical development, clinical operations, regulatory and quality teams
Lead PK-PD modeling and pharmacometrics workflows and manage related vendors/consultants for timely deliverables
Design and oversee pharmacokinetic and pharmacodynamic studies to support dose selection, safety assessments, and efficacy evaluations
Evaluate, select and manage CROs/consultants that meet the specific program's needs and timelines
Maintain excellent relationships built on transparent and effective communications with external stakeholders
Keep abreast with current regulatory and industry practices in clinical pharmacology for biologics development
Provide clinical pharmacology expertise for regulatory interactions and submissions, including IND, NDA/BLA filings
Be a dedicated team player and flexible with constructive feedback from other functional leads unique to each program goals and challenges
Excellent program management skills combined with a strong scientific mindset
Requirements:
PhD or equivalent in Clinical Pharmacology, Pharmacometrics, or a related field
Minimum of 6 years of experience in clinical pharmacology and pharmacometrics within the pharmaceutical or biotechnology industry
Prior experience managing/leading program level clinical pharmacology deliverables at a Biopharma or Biotech is highly preferred. Alternatively, experience working at CROs leading clinical pharmacology and/or pharmacometrics workflows for biologics development is also considered
Demonstrated expertise in analyzing/interpreting clinical pharmacology endpoints (PK, PD data) and using them for designing PK-PD modeling and pharmacometrics modules to achieve clinical PoC
Strong background in pharmacokinetic and pharmacodynamic principles, with hands-on experience in study design, data analysis, and interpretation
Prior working experience closely with clinical development, biostats and regulatory teams towards regulatory filings is highly preferred
Prior experience managing clinical pharmacology CROs/consultants is preferred
DMPK (Drug Metabolism and Pharmacokinetics) expertise and bioanalytical experience are preferred and would be valuable additions to the role
Experience with immunogenicity assessments for biologics is preferred
Awareness of Nonclinical PK and toxicokinetic (TK) assessment for regulatory filings is preferred but not a must