We’re working on behalf of a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. Their goal is to create a business that allows value creation and capture at the individual asset level, long-term sustainability, and continuity, while ultimately helping to improve the lives of patients. They are a team of highly dedicated, passionate individuals who pride themselves on a culture of respect, humility, transparency, dedication, collaboration, and fun. Their ultimate mission is to improve the lives of patients who are suffering.
Looking for a great opportunity? We seek candidates with experience in developing clinical pharmacology plans and in the preparation of regulatory submissions (including INDs, NDAs, BLAs and/or significant sNDAs/sBLAs) for the role of Clinical Pharmacology Leader. In this role you will act as the primary clinical pharmacology lead providing clinical pharmacology expertise to a multidisciplinary program and study teams. You will be responsible for clinical pharmacology programs of assigned projects and will be the key expert on all clinical pharmacology & pharmacometrics matters relating to assigned projects. You will work in close collaboration with different functions including Clinical, Non-clinical, Research, Regulatory, and Biometrics.
Candidates must have a PhD, MD or PharmD with relevant expertise in pharmacokinetics, pharmacology or pharmaceutical science. Must have 3+ years of direct industry experience in conducting clinical stage drug development. Must be experienced in developing clinical pharmacology plans and in the preparation of regulatory submissions (including INDs, NDAs, BLAs and/or significant sNDAs/sBLAs). Must be experienced in responding to regulatory questions related to all aspects of clinical pharmacology. Must have knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, and toxicology. Preference given to candidates with population PK/PD analysis and PBPK modeling experience. Must be experienced and skilled in working with matrix teams.
The role offers highly competitive compensation and excellent benefits. This is a terrific opportunity to join a team that is driven by doing great work, growing together, and conquering obstacles. They play almost as hard as they work and love what they do. For more information call 941.739.1400 or submit your resume now by clicking on the button below that says “Apply Now.”