Clinical Pharmacology Lead, Manager

Role Summary

Our Clinical Pharmacology Leads influence the discovery and development of drugs by providing clinical pharmacology and model-informed drug development (MIDD) expertise to project teams and regulatory interactions. The role involves integrating pharmacokinetics, pharmacodynamics, patient characteristics, and disease knowledge to inform development strategies, study designs, and dosage regimens.

Responsibilities

• Act as Clinical Pharmacology representative on Clinical Sub Team, Development Team and other multifunctional teams as appropriate.
• Provide expertise, leadership, and deliverables of clinical pharmacology for assigned projects within sphere of influence.
• With guidance, design and execute clinical pharmacology plans and implement best practices on project teams.
• Collaborate with other disciplines to ensure sufficient preclinical PK/PD knowledge exists to underwrite safe human administration and to establish a predictive model prior to FIH.
• Plan and oversee clinical pharmacology aspects at the project level (e.g., clinical development plan, PK/PD analyses, biomarker measurement strategies).
• Plan and oversee study-level activities including protocol authoring, clinical phase oversight, and reporting.
• With guidance, support dose-range finding strategies to achieve optimal doses and dosage regimens in patients.
• Ensure design and implementation of End-to-End MIDD plan conforms to best practices.
• Apply innovative analytical methods to integrate PK, PD, patient characteristics, and disease states to optimize doses and study designs.
• Contribute End-to-End clinical pharmacology input to regulatory documents (briefing documents, regulatory queries, Investigator’s Brochures, IND/NDAs/MAAs, etc.).
• Stay current with literature, regulatory guidelines, internal guidances, and SOPs.
• Influence external environment through publications, presentations, and representation at scientific societies and industry consortia.

Qualifications

• Required: Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
• Required: Strong quantitative skills and expertise (e.g., mechanistic PK/PD modeling, literature meta-analyses, population modeling, clinical trial simulations using NONMEM, R, etc.).
• Required: 0+ years of industry experience.
• Required: Excellent written and verbal communication skills.
• Required: Demonstrated presentation skills.
• Required: Demonstrated ability to influence and collaborate with peers to achieve meaningful outcomes and business impact.

Additional Requirements

• Hybrid work arrangement with on-site presence expected (approx. 2.5 days per week or more as needed).
• Relocation assistance may be available based on business needs and eligibility.