Associate Director, Clinical Operations
2 weeks ago
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
- 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
Apply: www.glshub.com
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