Vice President, Clinical Operations
60 First St, Cambridge, MA 02141
R & D – Clinical /
Full-time /
Hybrid
Company Summary: Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro’s lead program is Alpha-1 Antitrypsin Deficiency (AATD). Korro is based in Cambridge, Massachusetts.
We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.
Position Summary: We are seeking an experienced Vice President of Clinical Operations to provide strategic leadership for our clinical initiatives. This executive role will oversee the planning, execution, and management of clinical trials across multiple development phases, with an initial focus on rare disease indications, while ensuring operational excellence and regulatory compliance.
Key Responsibilities:
- 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.
Qualifications:
- 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.
Benefits: Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.
