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Responsibilities: Develop and execute global clinical development strategy, and communication of the global scientific/medical evidence plan for multiple indications Provide clinical/scientific input during the development and execution of clinical trials, including key observational studies Provide clinical content input to: Regulatory …..
Support various pharmacovigilance and risk management/minimization activities for investigational and marketed products Responsibilities: Author and coordinate/project manage development of periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc) Support preparation and maintenance of Risk Management plans Contribute to development of signal …..
The Director leads the project teams to design and implement clinical studies at high quality and in a time- and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines. Responsibilities: Provide medical monitoring …..
Description of Role We are currently seeking an experienced, creative, and highly motivated Process Developer to build in-house manufacturing capabilities including but not limited to: innovative systems, building a team, and identifying and removing barriers to efficient production of complex …..
The Early Development Leader (EDL) will be responsible for providing scientific/ medical direction and leadership for pre-clinical/ early clinical programs for biotech’s Early Development cardiovascular-metabolic pipeline. The Medical Director will lead the early phase clinical development of compounds in the cardiovascular-metabolic …..