·       Clinical Development Strategy: Develop and implement clinical development plans for RNA-based therapeutics, including study design, protocol development, and overall clinical trial strategy.

·       Study Execution: Oversee the planning, initiation, conduct, and closeout of clinical trials, ensuring adherence to protocol, regulatory requirements, and timelines.

·       Data Management and Analysis: Collaborate with cross-functional teams to ensure high-quality clinical trial data collection, management, and analysis in accordance with GCP standards.

·       Safety Monitoring: Manage safety monitoring activities, including adverse event reporting, safety data review, and risk management strategies to ensure patient safety throughout clinical development.

·       Regulatory Compliance: Ensure compliance with regulatory requirements, guidelines, and standards governing the conduct of clinical trials, including FDA, EMA, and ICH guidelines.

·       Cross-Functional Collaboration: Collaborate closely with other functional areas, including Regulatory Affairs, Clinical Operations, Medical Affairs, and Translational Sciences, to align clinical development activities with overall development plans and goals.

·       KOL Engagement: Build and maintain relationships with key opinion leaders and external experts to gather insights, drive scientific exchange, and inform clinical 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.

·       Budget Management: Develop and manage clinical trial budgets, including forecasting and tracking of expenses, to ensure efficient resource allocation and cost-effective trial execution.

·       Team Development: Build and mentor a high-performing clinical development team, fostering a culture of excellence, collaboration, and continuous learning.

·       Advanced degree in life sciences or related field (MD, PhD, or equivalent).

·       Medical specialty training with Board Certification.

·       Minimum of 8 years of experience in clinical development within the biotech/pharmaceutical industry, with a focus on drug development and clinical trial management.

·       Experience in rare disease indications and RNA therapeutics is highly desirable.

·       Strong understanding of clinical trial design, conduct, and execution, with knowledge of GCP and regulatory requirements.

·       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.

·       Opportunity to be at the forefront of clinical innovation in the development of RNA-based therapeutics for rare diseases.

·       Collaborative and entrepreneurial work environment where innovation and creativity are encouraged and valued.

·       Competitive compensation package including salary, bonus, equity, and benefits.

·       If you are passionate about advancing the development of cutting-edge RNA therapeutics and thrive in a dynamic and fast-paced environment, we encourage you to apply for this exciting opportunity to join the Korro Bio team.