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Dinan

    Director of Clinical Operations - McLean, United States - Global Life Science Hub

    Global Life Science Hub
    Global Life Science Hub McLean, United States

    2 weeks ago

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    Description


    Global Life Science Hub is partnered with an incredibly unique and revolutionary biotech company, developing an insane alternative to chemotherapy treatment by creating a unique receptor-binding protein that can fuse multiple immunotherapeutic vaccines to target numerous cancers.

    The company's pipeline includes several promising large molecules and small molecules that have the potential to significantly improve patient outcomes and quality of life.

    Following significant Series A funding from industry giants, they are now searching for an experienced Director, Clinical Operations to set up the in-house clinical monitoring team as they look to enter the clinic with their first product.


    Responsibilities:
    Lead the Clinical Operations function with strategic vision and operational expertise.
    Oversee global clinical programs, ensuring they are executed efficiently and meet organizational goals.
    Manage a cross-functional team, providing mentorship and guidance for success.
    Collaborate with the product development team to shape strategy and guide trial conduct.
    Provide operational and clinical expertise, from early to late-phase development.
    Drive products from Phase 1 to NDA approval, ensuring scientific excellence and profitability.
    Work closely with the Senior Leadership Team (SLT) to shape the strategic direction of Clinical Operations.
    Recruit, develop, and retain top talent for leadership roles within the team.
    Optimize resource allocation and foster cross-functional collaboration to meet project objectives within budget and timelines.
    Cultivate a culture of scientific and discipline excellence within the team.
    Establish collaborative relationships, particularly with Regulatory Affairs, to achieve strategic goals.
    Actively engage in business development efforts, identifying new partnerships and collaborations.
    Collaborate closely with Quality Management to ensure ongoing compliance and regulatory adherence.

    Qualifications:
    Bachelor's degree in life sciences or related field; advanced degree preferred.
    10-15 years of experience in Clinical Operations within pharmaceutical/biotechnology industry.
    Ideally 3-5 years in a similar leadership role, demonstrating strategic oversight.
    Proven track record of managing CROs and vendors effectively.
    Extensive experience in clinical trial management across all phases of development.
    Strong understanding of FDA, EMA, and PDMA regulations and guidelines.
    Exceptional written and verbal communication skills.
    Strong ethical values and ability to build and lead high-performing teams.

    Apply:
    The Global Life Science Hub are a niche Life Science headhunting firm.

    We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

    If you're interested, please apply below. If this position doesn't interest you, please visit our website for a list of more vacancies –

    #J-18808-Ljbffr
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