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BeOne

Global oncology therapeutics discovery, development, manufacturing

Director – GCO Program Lead

Clinical Research OperationsPosted on Nov 5
Full-timeRemote in USA

About the Job

Requirements

  • A bachelor's degree or higher in a scientific or healthcare discipline is required.
  • At least 10 years of experience in the clinical trial industry is required.
  • Experience across the full lifecycle of multi-region or multi-country clinical trials in a fast-paced global environment is required.
  • Working knowledge of International Council for Harmonisation Good Clinical Practice guidelines and other applicable regulatory requirements is required.
  • Microsoft Office computer skills are required.
  • Candidates should have lung cancer experience.

Responsibilities

  • Lead strategic operational planning and clinical operational performance for designated programs, and act as an escalation point for resolving study issues.
  • Lead gCSMs in designated programs, provide mentorship and feedback, and foster talent development.
  • Partner with program leads and functional representatives to drive disease and asset strategy and execution excellence.
  • Build, develop, and retain the global gCSM team, including hiring, training, mentoring, developing direct and indirect reports, conducting performance appraisals, and managing resources.
  • Oversee project delivery and goal achievement within designated programs, and resolve escalated issues.
  • Collaborate with other GCPLs to define and implement cross-program strategies and priorities, and establish global standards for goals, performance measures, and gCSM capability development.
  • Represent GCO for designated programs in governance activities, providing clinical operational insight to drive program strategy and execution.
  • Lead or participate in key opinion leader engagement activities and act as a functional spokesperson when needed.
  • Evaluate and develop strategic feasibility assessments and budget estimates during early planning for new clinical development plans and following strategy changes during studies, as needed.
  • Allocate resources and initiate clinical study team formation, ensuring appropriate transition of early-planning outputs to gCSMs.
  • Create and manage annual program budgets and resource forecasts, and contribute to and track program goals.
  • Create, review, and maintain compound-level documents, including investigator brochures, development safety update reports, and protocols.
  • Oversee timely, high-quality, and efficient planning and execution of studies within allocated programs.
  • Conduct regular program review meetings to mentor and support teams and ensure studies track to approved budgets and timelines.
  • Report study status, goals, and operational key performance indicators, and enforce quality indicators with Compliance team support.
  • Collaborate with other GCPLs to evaluate and designate preferred global vendors and participate in vendor governance meetings.
  • Create or review performance and development plans for direct reports and support delivery of their goals.
  • Provide line management and mentorship to gCSMs working within designated programs.
  • Lead efforts to deepen scientific knowledge within Clinical Operations.
  • Promote a global mindset and collaboration across Clinical Operations.
  • Serve as the escalation point for compound-related issues.
  • Drive process improvement initiatives with the Franchise Head and other GCPLs.
  • Collaborate with cross-functional leaders to provide operational perspectives that support effective delivery of clinical development goals.

Desired Qualifications

  • Experience in both people management and program management is preferred.

About the Company

BeOne

Global oncology therapeutics discovery, development, manufacturing

BeOne Medicines discovers, develops, and commercializes oncology therapies worldwide, focusing on hematologic cancers and solid tumors. Its products work by leveraging internal R&D and clinical development to bring therapies to market quickly, with Brukinsa serving as a leading backbone in the US and European markets. It differentiates itself through a large-scale global clinical network and cost-efficient development and manufacturing that support high margins and a focus on large-market cancer indications. Its goal is to expand access to high-impact, affordable cancer treatments across more than 45 countries while growing its pipeline into immunology and solid tumors.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Dongcheng District, China
Founded
2010

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