The Manager/Senior Manager will be responsible for managing and executing clinical pharmacology functional deliverables in collaboration with internal and external partners in an efficient and scientifically rigorous manner. This individual will be accountable for contributing to the design, execution, PKPD analysis, interpretation and reporting of clinical pharmacology study results including but not limited to first-in-human, drug interaction, biopharmaceutics and mass balance studies in addition to pre-clinical studies that support FIH studies. This will be accomplished by working in close partnership with senior Clinical Pharmacology colleagues. The incumbent is expected to establish and develop strong relationships with key cross functional partner functions such as clinical operations, clinical development, biostatistics, data management, medical writing, regulatory, and safety and therefore must possess good communication and interpersonal skills. The differentiation between the manager and senior manager levels is based on the ability of the incumbent to work independently and by demonstration of managing the expectations effectively.
· The incumbent will independently represent Clinical Pharmacology as a core member of clinical trial teams: Contributing to clinical trial designs, Authoring functional sections of clinical study protocols, Finalizing clinical study reports. Lead internal DMPK sub-teams to define DMPK strategy for compound development. Align development plans with sub-teams, study teams and manager;
· Manage CROs for non-clinical, TK and clinical pharmacology related studies and activities by developing study timelines, objectives and budgets, ensuring accuracy of project progress and completion and pro-actively identifying hurdles and providing solutions.
· Analyze and interpret PK/PD data generated during conduct of the clinical trials while communicating results and impact of results in a timely and effective manner to clinical study teams and development sub-teams.
· Conduct Clin Pharm based assessment of in-licensing opportunities
· Complete all required organizational trainings and requirements according to corporate timelines and adhere to the appropriate SOP and GxP guidelines
· Around 1-3 years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of clinical trials preferably within the pharmaceutical or biotech industry.
· Pertinent knowledge of biologics and clinical immunology is required.
· Hands on knowledge of PK/PD and statistical analyses methods used in analyzing clinical data is required.
· Excellent written and oral communication skills. Executive presentation skills are necessary.
· Good track record of publishing scientific research.
Major Skills (Technical & soft skills)
· Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using WinNonlin, NONMEM and potentially, other data analysis software.
· Demonstrable academic excellence in clinical pharmacology, drug metabolism, protein chemistry, immunology and cell biology
· Proficient in the use of Microsoft Word, Excel and Powerpoint
· Doctoral degree (PhD or national Equivalent) in clinical pharmacology, pharmacokinetics, pharmacology, or relevant discipline.