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Senior Manager, Clinical Site Budgets and Outsourcing - Contract Position

Lyell Immunopharma · USA · On-site

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About Lyell Immunopharma

Lyell is a T cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors. Backed by 8VC.

About the role

Support the Clinical Development organization at a pivotal point in the company’s growth. This role owns the outsourcing lifecycle for assigned US and ex-US clinical programs under Lyell’s Clinical Development portfolio – vendor selection, financial due diligence, contract and change order negotiations, ongoing vendor performance, and spend management – in support of Clinical Development, Drug Safety, and Regulatory. Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • Bachelor of Science or Bachelor of Arts
  • Minimum 5 years of site budget and outsourcing experience in the biotech or pharmaceutical industry
  • Demonstrated experience developing, negotiating, and managing clinical trial site budgets, direct clinical site experience and navigating ex-US sites from a sponsor perspective is a plus
  • Experience with CRO and vendor contract negotiation and financial management, including validating CRO investigator grant assumptions, ex-US experience is a plus
  • Prior leadership and managerial experience in clinical outsourcing, experience with oncology trials, including cell therapy, CAR T, or other complex trial experience is preferred
  • Working knowledge of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines as they relate to sponsor clinical trial conduct and sponsor vendor oversight
More about this role

Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of...

Read the full posting on Lyell Immunopharma's site ↗

Clinical Operations

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