Sr. Director role in clinical pharmacology available in MA. This is a fantastic "first in" opportunity. please contact me for more info. Description below. [email protected]<mailto:[email protected]>
* Lead the Clinical Pharmacology strategy to create sound, innovative and efficient programs that meet regulatory requirements, corporate and R&D program goals, and facilitate development from Phase 1 to commercialization * Provide clinical pharmacology expertise in design and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) aspects of clinical studies, including determining study design details, development of PK/PD models, special populations, dosing, evaluating clinical safety, efficacy, and patient selection strategies and predictive biomarkers * preparation of the clinical pharmacology portions of regulatory documents such as the pre-IND, IND, IB, briefing documents, clinical study reports, CTA and filing documents, while working in collaboration with cross functional team * Work with the discovery preclinical DMPK colleagues to optimize preclinical models and inform first in patient clinical dosing strategies * Perform with adherence to agreed timelines and budgets to ensure execution of deliverables * Represent Clinical Pharmacology and provide subject matter expertise on cross-functional project teams, clinical study teams and translational medicine teams * Identify/manage consultants and vendors to support Clinical Pharmacology studies * Excellent written and oral presentation skills * Strong critical thinking and the ability to work effectively with cross-functional teams in a matrix environment * Can work independently with minimal supervision Position Requirements Job Requirements: * MD, PharmD, or PhD with at least 10 years of Clinical Pharmacology experience (Level commensurate with experience-can be adjusted) * Experience in a pharmaceutical or biotechnology industry role is preferred * Strong understanding of Clinical Pharmacology principles, the drug development process and regulatory requirements to support Clinical Pharmacology strategies * Proven excellence in applying technical knowledge to strategic planning [cid:[email protected]] Brenda Roseberry Division Manager-Scientific Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers 720-328-9526 - Office 315-415-4353 - Mobile 720-475-1176 - Fax [linked logo] <https://www.linkedin.com/in/brenda-roseberry-1608166/?msgConversationId=6641167769234657280&msgOverlay=true>
