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    Clinical Development Director - Cambridge, United States - Korro Bio, Inc.

    Korro Bio, Inc.
    Korro Bio, Inc. Cambridge, United States

    6 days ago

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    Description


    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 main therapeutic area 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.

    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:


    • 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.
    Why Join Korro Bio:


    • 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.
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