Jobs in All Categories (16) Human Resources & Legal (2) Operations & General Management (2) Sales & Business Development (1) Science & Education (11)
Develops and runs quantitative cell-based assays employing primary cells or engineered cell lines to support drug discovery project teams.
Focus on the end results of the sales process, demonstrating personal accountability, sense of urgency and commitment to achieve business objectives.
Ensure that all activities, interactions and communications are compliant with the policies and SOPs of Array Biopharma, and adheres to OIG, ACCME, and PhRMA guidelines/policies.
Oversees the Clinical Data Management Department, with direct supervisory responsibilities for all in-house and external data management personnel (e.g., contractors and functional service providers)
Scheduling and coordinating GMP external audits and developing appropriate corrective and preventive action plans working closely with Quality Operations.
Residing in our Boulder, CO office the Clinical Supplies role will perform all clinical supply chain activities through all stages of a clinical trial, from start-up through study close-out.
Communicates with external authors/contributors on Array's publishing requirements and ensures consistency in external vendor produced documents and deliverables.
Responsible for developing and implementing robust contingency and issue management plans to solve complex issues that impact study or program milestones.
Responsible for the oversight and management of assigned regulatory activities (US and EU/ROW) to support Array oncology clinical trials.
Provides CMC regulatory support for Array clinical development programs (e.g., Module 3 submissions, IMPDs, Annual Reports, etc.
Develops and reviews local medical information content, ensuring accuracy, currency and scientific balance of all scientific and clinical information.
Responsible for creating and maintaining a program management framework that enables cross-functional teams to execute programs successfully.
Proactively researches domestic and international GCP trends and initiatives to ensure compliance for internal and external services.
Develops and implements quantitative cell based assays using either primary cell lines or transfected cells.
Manage full life cycle recruitment including, working closely with hiring managers/department heads to understand their staffing needs and priorities.