Senior Director, Clinical Pharmacology and Quantitative Pharmacology (CPQP)

Introduction to role

The Senior Director of Clinical Pharmacology & Quantitative Pharmacology (CPQP) is a pivotal leadership position within the Development, Regulatory and Safety (DRS) organization. This role provides both technical and strategic leadership on Therapeutic Area (TA) specific issues related to non-clinical, clinical, and quantitative pharmacology, posology, and risk-benefit from the discovery stage through to post-marketing support (PMS). The incumbent ensures the implementation of a model-informed drug development (MIDD) paradigm to R&D strategy at all stages. Responsibilities include providing TA-specific non-clinical, clinical, and quantitative pharmacology functional line leadership and oversight in designing and implementing non-clinical, DMPK, and toxicokinetic (TK) studies during the discovery phase, as well as FIH, POC, Phase 1 to 4 studies during the clinical development phase for R&D projects. Additionally, the role involves managing the company’s technical and strategic needs for conducting in-licensing activities and actively participating in key TA-specific decisions at R&D governance milestones.

Accountabilities

Lead CPQP sub-team within a defined Therapeutic Area of Development, Regulatory and Safety (DRS) organization ensuring implementation of AZ’s 5R Development Framework by :

• Providing functional leadership on the project team(s), individually and collaborating across other DRS functions.
• Optimally managing internal resources and ensuring quality and efficiency of external resources.
• Leading integration of non-clinical and clinical PK / PD / Immunogenicity strategy spanning animal POC, TK, IND enabling ADME package, FIH, Phase 1 and 2, POC, and late phase (Phase 2-3) trials, and regulatory interactions and documentations. Ensuring alignment from project teams across Clinical-CMC-Commercial triad and participating in discussions and presentations to senior management.
• Directing / driving non-clinical activities up to IND and supporting internal go-no-go decisions at Alexion : In vitro metabolism, non-clinical ADME, PK-PD data analysis and interpretation from animal models, TK and evaluation of potential drug-drug interactions of new biological / small molecule entities; recommending the starting dose in FIH trials based on allometric scaling or physiologically based PK modeling.
• Directing / implementing clinical activities post IND up to registration; supporting internal go-no-go decisions at Alexion : FIH to Phase 2 data analysis to recommend Phase 3 dose regimen; Phase 3 data analysis and authoring registration documents; Authoring clinical pharmacology development plans and supporting generation of integrated clinical development plan (ICDP); Contributing to the preparation of the pre-IND, IND, IB, IMPD, and regulatory briefing documents.
• Selecting and justifying dosing regimen for nonclinical studies and FIH studies during the pre-IND stage and dosing for Phase 2 / 3 studies by ensuring integrated data analysis support.
• Managing TA-specific technical and strategic needs for conducting in-licensing activities.

Essential Skills / Experience

Desirable Skills / Experience

Prior multi-disciplinary team-facing experience in a CPQP role is preferred.

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