Job Description

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 required
• 10+ 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 operations
• Experience in successful study initiation through study completion/primary data analysis and in multiple phases of studies (Phase 1-3)
• Must possess good communication skills.

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