Associate Director, Clinical Operations

 Associate Director, Clinical Operations
Global Life Science Hub is partnered with a mid-size T-Cell Immunotherapy Biotech based in Texas. Due to expansion, they are looking to appoint a new Associate Director of Clinical Operations who will play a key role in leading our Clinical Operations function, ensuring strategic alignment, operational excellence, and successful delivery of clinical programs. This position requires a dynamic individual who can inspire teams, collaborate with stakeholders, and contribute to our innovative pipeline.
Key Responsibilities:
Lead the Clinical Operations function with strategic vision and operational expertise.
Oversee global clinical programs, ensuring they are executed efficiently and meet organizational goals.
Manage a cross-functional team, providing mentorship and guidance for success.
Collaborate with the product development team to shape strategy and guide trial conduct.
Provide operational and clinical expertise for Oncology trials, from early to late-phase development.
Drive products from Phase 1 to NDA approval, ensuring scientific excellence and profitability.
Work closely with the Senior Leadership Team (SLT) to shape the strategic direction of Clinical Operations.
Recruit, develop, and retain top talent for leadership roles within the team.
Optimize resource allocation and foster cross-functional collaboration to meet project objectives within budget and timelines.
Cultivate a culture of scientific and discipline excellence within the team.
Establish collaborative relationships, particularly with Regulatory Affairs, to achieve strategic goals.
Actively engage in business development efforts, identifying new partnerships and collaborations.
Collaborate closely with Quality Management to ensure ongoing compliance and regulatory adherence.
 
Qualifications:
Bachelor's degree in life sciences or related field; advanced degree preferred.
10-15 years of experience in Clinical Operations within pharmaceutical/biotechnology industry.
Ideally 3-5 years in a similar leadership role, demonstrating strategic oversight.
Proven track record of managing CROs and vendors effectively.
Extensive experience in clinical trial management across all phases of development.
Strong understanding of FDA, EMA, and PDMA regulations and guidelines.
Exceptional written and verbal communication skills.
Strong ethical values and ability to build and lead high-performing teams.
Global Life Science Hub is a niche Life Science headhunting firm specializing in placing professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical, and CRO companies ranging from small start-ups to large global organizations.
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