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.

Apply: www.glshub.com