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Senior Director, Clinical Quality

Company: Arcellx, Inc.
Location: Redwood City
Posted on: June 1, 2024

Job Description:

Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.Our team members are made up of talented innovators and dreamers working from our offices in Gaithersburg, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.What Matters to UsLiving our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.Arcellx Core Values

  • Character: Committed to always doing what's right.
  • Audacity: Willing to challenge convention and share candid feedback with others.
  • Determination: Curious and self-motivated. Always looking to improve and learn.
  • Collaboration: "No job is too small" mentality. Humble and willing to help others.
  • Originality: Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.How You'll Make a DifferenceAs our Senior Director, Clinical Quality, your mission is to manage all GCP oversight as it relates to Arcellx's phase I, II and III clinical studies. Partnering with clinical and medical affairs, you'll ensure our quality system provides sufficient oversight and is compliant with applicable regulations for our GCP programs and activities. In this role, your work will directly impact our ability to run successful clinical trials and get our potentially life-saving therapy to patients.The "Fine Print" - What You'll Do
    • Develop and implement programs that support Arcellx's GCP-regulated activities.
    • Lead the GCP supplier management and oversight programs including developing audit schedules, performing audits and the creation of quality agreements.
    • Represent Quality on clinical project teams and act as the GCP Quality lead for the oversight of all Quality aspects performed at Clinical Research Organizations (CROs) contract laboratories and clinical sites.
    • Assist in the development and implementation of systems to ensure clinical adverse event reporting and tracking and robust data integrity programs.
    • Support regulatory inspection (BIMO) readiness activities as it relates to any Arcellx phase II/ phase III clinical studies.
    • Partner with the VP of Quality in creation of clinical quality department goals and metrics.Skills and Experience We Look For
      • Bachelor's degree and 10+ years' experience working within GCP a regulated environment. Experience with GLP and GVP is a plus. We will consider less experienced candidates at the director level. -
      • Experience implementing and integrating clinical quality systems in CBER regulated biotechnology companies. Cell and gene therapy and especially CAR-T therapy a plus.
      • Knowledge of applicable GCP regulations and industry guidance.
      • Demonstrated ability to assess risk and prioritize effectively, with the ability to work with aggressive timeframes and adhere to project deadlines in a fast-paced environment.
      • Strong communication and presentation skills with good executive presence.Rewards at ArcellxOur people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.The base salary range for this position is $270,000 - $295,000 per year. Where a candidate falls within that range is determined by factors such as years of experience and location. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more. -Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to www.arcellx.com . Arcellx is an onsite company that believes in the power of in-person connection and collaboration. Our beautifully designed office provides space for quiet, focused work, while fostering opportunities for meaningful engagement with colleagues. Are you willing and able to work onsite in our Redwood City, CA office? -*
        Please select Are you authorized to work for any employer in the United States? -*
        -- Will you now or in the future require visa sponsorship? -*
        -- What makes you an ideal candidate for this role and a great fit for our company? Briefly tell us about your unique combination of work experience and values. -*

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Keywords: Arcellx, Inc., Redwood City , Senior Director, Clinical Quality, Healthcare , Redwood City, California

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