• 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, Investigator’s 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.