Vice President, Clinical Operations
- Strategic Leadership: Provide strategic direction and leadership for the planning, execution, and management of clinical trials across multiple phases of development, with an initial focus on rare disease indications.
- Operational Oversight: Oversee the operational aspects of clinical trials, including study planning, site selection, budget management, vendor selection and management, and overall timeline management.
- Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Medical Affairs, and Translational Sciences, to ensure alignment of clinical operations with overall development strategies.
- Vendor Management: Manage relationships with CROs, central laboratories, and other external vendors to ensure the highest quality of deliverables within budget and timelines.
- Compliance and Quality Assurance: Ensure compliance with relevant regulatory requirements, industry standards, and company SOPs. Implement and maintain robust quality systems to ensure data integrity and patient safety.
- Resource Planning and Budget Management: Develop and manage clinical trial budgets, including forecasting and tracking of expenses. Identify opportunities for cost optimization and efficiency improvements.
- Risk Management: Proactively identify risks and implement risk mitigation strategies to minimize potential impact on clinical trial timelines and outcomes.
- Team Development: Build and mentor a high-performing clinical operations team, fostering a culture of excellence, innovation, and continuous learning.
- Advanced degree in life sciences or related field (Masters, PharmD, PhD, or equivalent).
- Minimum of 10 years of experience in clinical operations within the biotech/pharmaceutical industry, with a proven track record of success in managing complex clinical trials.
- Extensive experience within both CRO and sponsor environments, with a deep understanding of industry best practices and regulations governing clinical research.
- Prior experience in RNA therapeutics and rare disease indications is highly desirable.
- Strong leadership and management skills, with the ability to inspire and motivate cross-functional teams.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.
- Meticulous attention to detail, with a focus on quality, accuracy, and compliance.
- Proven ability to work in a fast-paced, dynamic environment and adapt to changing priorities.
- Budget-conscious mindset with a track record of delivering projects on time and within budget.
- Domestic and international travel required up to 20%. (Australia & New Zealand)
- Ability to work onsite 3 days per week.
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