Senior Manager/Associate Director Clinical Operations Apply
Position Overview:This role will be responsible to connect science and operations to bring clinical studies to life through the execution of company’s global clinical research programs. She/he serves as a strategic advocate for pipeline assets and provides operational reality to our scientific drugs via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges.Responsibilities:Develop clinical operational strategy and ensure clinical research programs are executed with quality and efficiency, on-time, within budget, and to meet company objectives.Translate asset strategy into operational execution by developing the clinical operations plan (or strategy) and connecting the science with the business, operations, patients and our customers.Identify and evaluate risks and mitigations at program level to achieving the asset strategy.Interacts with and influences all levels of management and cross-functional team members to achieve program objectives and represents Clinical Operations at senior leader cross functional meetings.Reviews and provides clinical operations content to clinical and regulatory documents.Execute clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and Company policies and procedures).Strong communication and stakeholder management skills. Is comfortable with not having all the information yet able to drive activities and find solutions to deliver on the program.Qualifications:Bachelor’s degree or equivalent is required10+ years of Pharma-related/ clinical operations related experience (and/or applicable work experience)Must have 8 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical and leadership competencies through setting and driving strategy.Proven ability in leading a global team in the management and completion of multiple, complex clinical studies.Expertise in Subject Matter and competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)Integral participation in initiatives or advancement strategies for clinical operationsExperience in successful study initiation through study completion/primary data analysis and in multiple phases of studies (Phase 1-3)Must possess good communication skills.