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/ExperienceDoctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacology/cell biology/immunology, or relevant field.At least 15 years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics and other CP and QP components of early- and late-stage clinical trials.Knowledge of data analysis methodologies for implementation in analyzing early- and late-stage clinical phase data, including applying model-informed drug development (MIDD) strategies to inform program decision-making.Knowledge of general regulatory process and experience in contributing to IND, EOP1, EOP2, and pre-BLA/NDA meetings with the FDA and EMA.Strong business insight including knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, research, biostatistics, clinical pharmacology, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development processDesirable Skills/Experience

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

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the entrepreneurial spirit of a leading biotech while meeting the needs of some of the most under-served patients in the world! You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys.

If this sounds like a team you want to be a part of... then we’d love to talk.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.