Associate Clinical Lead Director- CAR-T and Cell Gene Therapy
$106,100–$295,500 year
On-siteDurham, North Carolina, United States
Job Summary
Ensure clinical delivery of assigned CAR-T and cell gene therapy projects in compliance with ICH-GCP, protocols, and customer contracts. Account for recruitment targets, develop risk mitigation plans, and manage clinical quality standards throughout the project lifecycle. Lead clinical teams, oversee project finances including Estimate at Completion, and act as the primary Clinical Lead for large, multi-regional studies. Manage internal and external stakeholders, conduct site visits, and mentor new peers while collaborating with functional teams to achieve milestones. Develop clinical operation plans for business proposals and participate in bid defenses.
Required Qualifications
- Bachelor's Degree Health care or other scientific discipline
- 10 years clinical research/monitoring experience or equivalent combination of education, training and experience
- in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- consolidated knowledge of Project Management practices and terminology
- high proficiencies in using systems and technology to achieve work objectives
- good knowledge of project finances
- Knowledge of clinical trial conduct
- skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct
- Strong written and verbal communication skills including good command of English language
- Problem solving skills
- Planning, time management and prioritization skills
- Ability to handle conflicting priorities
- Attention to detail and accuracy in work
- Good influencing and negotiation skills
- Good judgment and decision-making skills
- Effective mentoring and training skills
- fostering learning and knowledge sharing with colleagues
- Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint
- Ability to establish and maintain effective working
- Ability to work across geographies displaying high awareness and understanding of cultural differences
- Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership)
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