Associate Director, Clinical Pharmacology Lead

Role Summary

Clinical Pharmacology Lead (Associate Director). Our Clinical Pharmacology Leads have key roles to play in influencing the discovery and development of drugs. The ideal candidate is responsible for providing the clinical pharmacology and MIDD components of clinical plans and providing clinical pharmacology expertise to the project team and regulatory interactions. Working with multifunc­tional study teams, Clinical Pharmacology Leads utilize methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and diseases for rational development strategies and decisions, as well as optimal study designs and dosage regimen selections.

Responsibilities

• Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team and other multifunctional teams as appropriate.
• Provide expertise, leadership, and deliverables of clinical pharmacology for the assigned projects within sphere of influence.
• Design and execute clinical pharmacology plans and implement clinical pharmacology best practices on project teams.
• Work closely with other disciplines to ensure sufficient preclinical PK/PD knowledge exists to underwrite safe human administration and to establish the structure of a predictive model prior to FIH.
• Plan and oversee clinical pharmacology aspects at the project level (e.g., clinical development plan, implementation and interpretation of PK/PD analyses, PK/immunogenicity/biomarker measurement strategies, etc.).
• Plan and oversee study-level activities including protocol authoring, clinical phase oversight, and reporting.
• Responsible (with clinicians and statisticians) for ensuring appropriate dose-range finding strategies which ultimately will lead to optimal doses and dosage regimens in patients.
• Accountable for ensuring appropriate design and implementation of End-to-End MIDD plan that conforms with best practices.
• Ensure use of innovative analytical methods to integrate knowledge of PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs.
• Provide End-to-End clinical pharmacology contribution to regulatory documents (e.g., Briefing documents, Regulatory queries, Investigator‚Äôs Brochures, IND, NDA/MAA, etc.).
• Develop new methodologies through internal and/or external collaborations with world-leading experts.
• Coach less experienced colleagues and team members.
• Stay abreast of literature, regulatory guidelines, and internal guidance and SOPs.
• Influence external environment through publications, presentations, and representation at scientific societies and industrial consortium.

Qualifications

• Required: Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
• Required: 1+ years of industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics/Systems Pharmacology.
• Required: Intimate knowledge of drug development and experience in applying quantitative pharmacology approaches to knowledge integration.
• Required: Strong quantitative skills and expertise (e.g., mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, etc.).
• Required: Excellent written and verbal communication skills.
• Required: Demonstrated presentation skills.
• Required: Breadth of diverse leadership experiences and capabilities including the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.