About the job Provide clinical pharmacology support for programs through the worldwide marketing application filing, including supportive registration documents and presentations. Review and prepare documents for regulatory submission, including clinical development plans, Investigators Brochure, and the Clinical Pharmacology section of INDs, CTAs, and/or NDAs. Contribute to the clinical pharmacology sections of regulatory documents, including Investigator Brochures, documents for regulatory meetings, NDA/BLA/MAA. Participate in designing the overall clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the Company. Write and review scientific documents, such as Clinical Study Protocols, Standard Operating Procedures (SOPs), Statistical Analysis Plans, and Clinical Study Reports Collaborate with cross-functional teams, including clinical, clinical operations, regulatory affairs, and biostatistics, to ensure the successful execution of clinical trials Ensure the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology. Development and execution of clinical pharmacology strategies for late-stage development programs from Proof-of-Concept (Phase 2a) through worldwide marketing application. Oversee population PK, ER, c-QTc analyses conducted by the vendors and perform PK NCA analysis/fit-for-purpose PK/PD simulation if needed. Provide expert PK/PD advice to cross-function project teams. Advanced degree (PhD, PharmD, MSc) in Pharmacology, Pharmaceutical Sciences, or related field. Minimum of 5 years of experience in clinical pharmacology in the pharmaceutical industry. Strong knowledge of PK/PD principles and their application to clinical pharmacology. Familiarity with PK/PD software (e.g. WinNonlin, NONMEM, Monolix, R, etc) and working knowledge of MIDD concepts. Experience in oncology small molecule development is preferred. Experience in regulatory submissions and interactions with regulatory agencies. Experience in clinical pharmacology study design and interpretation. Experience in clinical pharmacology data analysis and reporting. Excellent written and verbal communication skills. Ability to work independently and as part of a team.Please use the below link for job application and quicker response:https://lifelancer.com/jobs/view/fcd11ffd1d32c21e6195655caea78ab6