Director Clinical Operations

Lineage Cell Therapeutics Logo
Lineage Cell Therapeutics
Carlsbad, CA, United States
  • IT
  • FlexTime
  • FullTime

DIRECTOR OF CLINICAL OPERATIONS

Lineage is seeking a Director of Clinical Operations to join our team.

This position is full-time, reporting to the SVP, Head of Clinical. The role requires on-site presence and is not available as a remote position. You will work out of Lineage’s headquarters located in Carlsbad, CA. Currently, the position is hybrid with established regular in-office and work-from-home hours. This role also requires both domestic and international travel.

SUMMARY OF ESSENTIAL FUNCTIONS:

Translate clinical development strategies into actionable plans. Oversee and execute the operational aspects of clinical trials to ensure they are conducted efficiently, compliantly, and within timelines and budget.

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:

  • Lead the development and implementation of clinical trial operational plans, including timelines, resource allocation, and vendor strategy. Ensure studies are initiated, conducted, and closed out according to protocol, regulatory requirements, and company standards. Act as a clinical representative on cross-functional teams.

  • Select, manage, and evaluate CROs, investigative sites, and other vendors. Ensure performance aligns with expectations, budgets are controlled, and deliverables meet quality standards. Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.

  • Maintain study-related databases and communicate relevant and timely study information, particularly regarding milestones or information of an urgent nature including safety events, to the appropriate team members

  • Assist with development of various clinical documents, including protocols, IB, ICF, case report forms, etc. Assist with authoring clinical sections of regulatory documents (e.g., DSUR, IND annual reports/NDA/BLA). Author or provide clinical input and review of other study-related documents (e.g., vendor spec documents, patient-facing materials, site instructions, training materials, recruitment materials, user acceptance testing). Prepare and circulate protocol-related reports as needed. Assist in the development of in-house operations, SOPs, guidelines, work instructions and systems.

  • Submit protocols to IRB/EC, assist clinical testing laboratories with IRB/EC submissions, and ensure collection and review of required essential study documents and reports. Oversee and support relevant DSMB functions.

  • Ensure that clinical study conduct and record management (e.g. Trial Master Files) are in adherence to global regulations and guidelines, company quality standards and standard operating procedures (SOPs)

  • Perform clinical data review, protocol deviation review/evaluation and oversight of subject safety

  • Prepare and circulate protocol-related reports as needed

  • Ensure accurate, timely data collection and reporting. Collaborate with data management and biostatistics teams to support interim analyses and final study results.

  • Assist with development of, and provide oversight of, clinical trial budgets. Monitor spend and optimize resource allocation, ensuring trials are delivered within financial constraints.

  • Ensure all activities meet regulatory requirements, identify risks and implement preventive measures and mitigation steps. Ensure adherence to quality in accordance with FDA, EMA, MOD, ISO, GCP, ICH, or other regulatory guidelines.

  • Assist in planning and executing clinical Investigator meetings, advisory board meetings, DSMB, study meetings, and vendor meetings as needed

  • Manage and mentor clinical operations staff, fostering a high-performance culture. Provide guidance on issue resolution, escalation management, and operational best practices.

POSITION REQUIREMENTS:

Education and Experience:

  • BS degree in a biologic/scientific discipline required. Master’s degree preferred.

  • Minimum 8 years of biotech, pharmaceutical or relevant CRO experience. Cell or Gene Therapy and/or Medical device experience is a plus.

  • Experience in management and execution of complex clinical trials

Knowledge and Skills:

  • Firm knowledge of FDA regulations and GCP/ICH Guidelines

  • Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and site management/monitoring

  • Strong program management skills, with a proven ability to lead complex clinical trial programs across multiple studies and phases.

  • Leadership, team management, communication, and analytical skills

  • Excellent written and oral communication skills

  • Strong computer skills (Excel, Word, PowerPoint) and solid presentation skills

Compensation: $215,000 — $250,000 (base)

Lineage Cell Therapeutics (LCTX) is a clinical-stage biotechnology company developing new cellular therapies for unmet medical needs. Successful Lineage team members are adaptable, accountable, engaged, collaborative, creative, and willing to roll up their sleeves to get any job done. We offer a challenging and motivating work environment, along with competitive salaries and a comprehensive benefits package.

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