Associate Director, Head of Regional Study Management

The Opportunity

CSL Behring is a global biotechnology leader, motivated by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

We are committed to creating a diverse and inclusive workplace environment, an environment where colleagues can fulfill their career aspirations, realize their potential, and use their unique perspectives and experiences to make a difference in a world that needs solutions to rare and serious disease

We are looking for an Associate Director of Study Management to Head our Americas Region. You will be a hybrid position.

The Associate Director is responsible for clinical operations strategic leadership to ensure conduct and oversight of monitoring and site management of clinical programs in the designated region following our strategy, appropriate international regulatory standards, and within the agreed timeframe and budget. You will be the strategic interface between therapeutic areas and study management to ensure the quality of the delivery of the clinical program(s) at the site level. You will oversee the permanent and functional service provider site management staff and build a strategic relationship with service providers and CROs at a regional level.

You will report to the Director of Site Partnerships within Global Clinical Operations and interface with Therapeutic Area Leads, Clinical Trial Supplies, Program Directors, Clinical Scientists, and other Clinical Development Operations Functional Managers. Also partner with Project Management, Regulatory Affairs, Legal, Clinical Quality Assurance, and Clinical Compliance and Oversight. Direct reports may include: Lead Clinical Site Ambassadors, Clinical Site Ambassadors, and Clinical Oversight Managers.

• Lead a regional organization that conducts and oversee the monitoring and site management of clinical programs to ensure patient safety, quality and integrity of study conduct, submission readiness, and regulatory compliance. Proficient in reviewing and assessing clinical data.
• Comprehensive knowledge of ICH guidelines/ GCPs.
• Evaluate, judge, and make recommendations regarding staff. Help with teaching/coaching and setting an example of 'best practice'.

Main Accountabilities:

• Oversee monitoring and site engagement from site identification to closeout of all study sites across the portfolio in the Americas
• Oversee, with partners, a growing region of ~35 consisting of both direct report and FSP resources
• Develop, mentoring, retaining, motivating and inspiring individuals in your group
• Create a culture of continuous improvement, always looking for ways to reduce cost and timelines, while maintaining excellent quality
• Main escalation point for monitoring and site related issues within the region
• A member of the Global Clinical Operations Leadership Team
• Contribute to the strategy of Global Clinical Operations especially as it relates to site management and engagement
• Help develop the processes and standards to allow inspection readiness of all clinical studies and ensuring compliance with quality standards. Manage internal quality processes following defined standards to ensure that quality is built in upfront, and checks are integrated into study activities.
• Be a SME related to processes important to the group
• Develop relationships with external partners to support our models and portfolio.

Qualifications:

• Bachelor's degree or equivalent. Life science, nursing, pharmacy, or other health/medical related area preferred. Post graduate qualifications preferred.
• 10+ years relevant clinical research experience within the pharmaceutical industry.
• Experience with the drug development process, and specifically each step within the clinical trial process.
• Experience overseeing global clinical trials (pharmaceutical or research institute).
• Budget forecasting and management.
• Experience with Vendor Management
• Knowledge of ICH guidelines/GCP and its applicability of all stages of clinical development process.
• Experience Managing teams in global Clinical Operations is necessary .

#LI-REMOTE

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.