Associate Director,Global Clinops Asset Lead

Responsibilities:
• Provides either leadership to, and management of one or more clinical programs within or across a designated Therapeutic Area (TA) or is a leader within a function that supports the operational delivery of the portfolio. Fully accountable for all global clinical operations deliverables to support the TAs.
• Ensures all clin ops activities that support the TA model are successfully planned, implemented and completed in accordance with the Company strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
• Negotiates or supports the negotiation of CDAs, contractual terms, rate cards, and other contractual items with all vendors that support the TA model. Drives ownership of all deliverables through effective oversight and governance of the vendors.
• At a study level, responsible for overall forecasts and management of budgets and resource allocation in collaboration with the Department Heads and clinical teams.
• Develops or supports the development of the processes, systems (e.g. eTMF) and standards to enable inspection readiness of all clinical studies as well as ensuring compliance with quality standards. Manages internal quality processes in line with defined standards to ensure that quality is built in upfront and checks are appropriately integrated into study activities.
• Drives a culture of continuous improvement, always looking for ways to reduce cost and timelines, while maintaining the highest level of quality.
• Accountable for developing, coaching, mentoring, retaining, motivating and inspiring individuals in their group.

Qualifications:
• Bachelor degree or equivalent. Life science, nursing, pharmacy, or other health/medical related area preferred. Post graduate qualifications preferred.
• Approximately 10 years relevant clinical research experience with additional experience in functional areas within the pharmaceutical industry.
• Solid understanding of the drug development process, and specifically each step within the clinical trial process.
• Experience overseeing global clinical trials
• Budget forecasting and management skills;
• Excellent vendor relationship management skills;
• Thorough knowledge of ICH guidelines/GCP and its applicability of all stages of clinical development process.
• Proven leadership and global Clinical Operations experience is essential.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.