Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.**Senior Director, Clinical and Non-Clinical Pharmacology****Location**:Barcelona, ES**Reports To**:Head of Non-Clinical, Clinical and Quantitative Pharmacology, CD&TS**This is what you will do**:- Lead a team of clinical pharmacologists and provide technical and strategic leadership on issues related to clinical pharmacology and pharmacokinetics and pharmacodynamics (PK/PD) from the discovery stage up to the post-marketing support (PMS) stage.- The overall responsibilities include providing clinical pharmacology functional line leadership and oversight in designing and executing, within the regulatory framework, non-clinical DMPK and toxicokinetic (TK) studies during the discovery phase, and FIH, POC, Phase 1 to 4 studies during the clinical development phase for R&D projects. The responsibilities also include managing company’s technical and strategic needs for conducting in-licensing activities. You will be responsible for ensuring Clinical Pharmacology support and is expected to actively participate in the key decisions at the R&D governance milestones. At the non-clinical stage, you will be responsible for providing leadership on key milestones up to IND filing by collaborating with toxicology, biomarker and pharmacometrics functions to enable selection of dose/regimen for FIH studies for all research programs. At the clinical stage, you will be responsible for authoring and strategizing clinical pharmacology development plans, identifying Phase 2/3 dose regimens by collaborating with other Translational Sciences/Medicine disciplines, providing strategic direction to the writing and review of reports and integrated summaries submitted to the regulatory authorities and interacting with the regulatory authorities. The responsibilities also include managing the department resources and budgets. At the enterprise level, the expectation is to provide leadership in cross-functional collaboration on companywide initiatives related to productivity, innovation, or efficiency.**You will be responsible for**:- Providing clinical pharmacology leadership on the project team(s), individually and through direct reports, and collaborating across other development functions- Leading development 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. Getting buy-in from project teams, as well as participating in discussions and presentations to senior management- Directing/executing non-clinical activities up to IND and supporting internal go-no-go milestone decisions at Alexion: In vitro metabolism, non-clinical ADME, PK-PD data analysis and interpretation from animal models, TK and evaluation of potential of drug-drug interactions of new biological/small molecule entities; recommend the starting dose in FIH trials based on allometric scaling or physiologically based PK modeling- Directing/executing clinical activities post IND up to registration; and supporting internalgo-no-go milestone 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); Contribute to the preparation of the pre-IND, IND, IB, IMPD, and regulatory briefing documents- Leading and ensuring selection of dosing regimen for nonclinical studies and FIH studies during the pre-IND stage and leading the selection of dose for Phase 2/3 studies by ensuring integrated data analysis support- Managing the company’s technical and strategic needs for conducting in-licensing activities.**You will need to have**:- Doctoral degree (PhD or national Equivalent) in pharmaceutical sciences, or relevant discipline.- PhD in field related to Pharmacokinetics and 15+ yrs of industry experience in Drug Development. Excellent verbal articulation and technical writing communication skills.- Advanced knowledge of and hands-on experience in PK/PD/Immunogenicity, modeling and simulation and drug development in multiple therapeutic areas. Experience across range of development phases is must. Extensive experience in developing the strategy & designing, directing & implementing clinical pharmacology plans for multiple compounds, both biologics and small molecules.- Knowl