Senior Director, Clinical Development

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 clinical development physician to lead one or more clinical programs at Korro. In this highly visible role reporting to the Chief Medical Officer, you will drive clinical development related activities for Korro’s lead program in Alpha-1 Antitrypsin Deficiency (AATD), as well as additional pipeline programs. This is an onsite role in Cambridge, Massachusetts, with a requirement to be in the office 3 days a week.Excellent written and oral communication skills are required, as is the desire and ability to work in a small, fast-paced, and patient-focused environment.

Key Responsibilities:

• 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.

Qualifications:

• Medical degree required (MD, MBBS, or equivalent).
• Sub-specialty training preferred, with Board Certification in immunology, pulmonary medicine, hepatology or neurology.
• Minimum of 8-10 years of experience in clinical development within the biotech or 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