Associate Director, Clinical Bio-sample and Supply Operations

Intellia Therapeutics

Date: 1 week ago
City: Cambridge, MA
Contract type: Full time
Intellia Therapeutics

Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

How you will Achieve More with Intellia:

We are excited to welcome this new member to our growing team and company. This is both a strategic and hands-on role. If you are an independently motivated and results-oriented person who enjoys collaborative team-oriented environments where results are achieved through influence and the incorporation of multiple points of view, this is the role for you! As the AD, Clinical Bio-sample and Supply Operations you will:

  • Establish, cultivate, and maintain scientific relationships with key laboratory vendors (e.g., central and analytical laboratories) and clinical trial ancillary supply vendors

  • Build out working partnerships with key Intellia stakeholders in Early Development, Pharmacology, R&D Medicine, Biometrics, Technical Operations, Strategic Sourcing, Finance, Legal, and Clinical Operations

    • Work with colleagues in Clinical Operations and cross-functionally to develop and implement best practices, processes and SOPs related to bio-sample and supply operations and part of the larger clinical trial operations for each clinical trial

    • Develop site initiation visit and interim monitoring visit training materials in collaboration with Intellia stakeholders, CRO, central and analytical laboratories, and ancillary supply vendors

  • Identify and develop processes to establish ancillary supply plans and bio-sample management plans for clinicals studies, including SOPs, policies, work flows, and work instructions around bio-sample shipment, customs regulations, storage, and usage.

  • In partnership with laboratories and CROs, provide end to end sample management and tracking of biological samples through the lifespan of the sample (from sample collection to databasing of results to sample destruction) for Intellia clinical studies

  • In partnership with the Clinical Operations team, and other stakeholders lead:

    • Drafting of bio-sample schedule of assessments, and key document sections for clinical protocols and informed consent forms related to bio-sample collection and long-term storage

    • IRB/EC and Regulatory Authority responses related to bio-sample collection and storage

    • Central laboratory and analytical laboratory scope of work(s), budget(s), and laboratory manual(s) development/updating

    • Development of bio-sample collection flow charts, collection tubes/kit builds, along with sample labeling and processing requirements, and shipping best practices and schedules

    • Coordinating timelines and communication between functional areas and relevant vendors, including support of laboratory data transfer and data discrepancy resolution processes, coordinating resolutions to meet study timelines

    • Track deliverables to closure and monitor filing to appropriate repository

    • Development of ancillary suppliers scope of work(s), budget(s) and attendant instructions for use

    • Provide updates on ancillary supplies and sample management issues/trends and resolution status to clinical study teams and stakeholder functions

  • In partnership with Compliance, Early Development and Pharmacology, lead the long-term sample storage vendor collaboration for Intellia’s clinical samples

  • Establish metrics and provide oversight of vendors providing services related to laboratory sample collection, processing, reporting, storage

  • Participate in study risk assessments and collaborate with the clinical study team on identifying risks related to bio-sample processes and establishing mitigation strategies

  • Serve as primary contact for 3rd party laboratory vendors, CROs and study site teams

  • Participate in eCRF design and UAT develop process, tools, procedures and reports to support ancillary supply and bio-sample function

About You:

  • Bachelor’s degree, Master’s degree, or PhD degree in related discipline and a minimum of 8 years of related experience

  • Strong experience in GCP/GLP/CLIA regulated environment

  • Strong understanding of US and ex-US regulations around bio-sample shipments, storage, and use

  • Deep knowledge of drug development process and fundamentals of clinical trial management, including solid background in ancillary supply operations and clinical sample collection, logistics and operations

  • Organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail

  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment

  • Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems

  • Perform all duties in keeping with Intellia’s core values, policies and all applicable regulations

Meet your future team:

The Development Operations group is a rapidly growing and valued team within Intellia and is comprised of respected professionals with diverse regulatory expertise in both large pharma and small biotech settings. Eager to move exciting projects forward, we are motivated by the opportunity to make an impact for patients!

The Development Operations group is currently a mix of remote, hybrid, and onsite, and we are open to applicants working remotely for this role. Although in a virtual environment, the group has made it a priority to continue to foster a sense of community! You can expect to join a hardworking, collaborative environment.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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