Careers

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell 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.

Please send your resume to [email protected] if you would like to be part of this growing and dynamic team.

Currently Available Positions

HEAD OF REGULATORY AFFAIRS

Lineage is seeking a seasoned regulatory leader to join our team. This is a new full-time position, reporting to the CEO, and working out of Lineage’s headquarters in Carlsbad, CA.

This is a hands-on role that will require the ability to collaborate with project team members and management to develop and execute our communication strategy with FDA and other regulatory agencies regarding study designs and issues related to current and future programs. As an important external representative of the Company this role also requires a proactive approach to engagement with agencies, therapeutic area experts, and other stakeholders. 

SUMMARY OF ESSENTIAL FUNCTIONS: 

Responsible for the management and leadership of regulatory development activities for Lineage’s cell therapy platform. Provide expert regulatory guidance to the Company, reflecting current thinking at the FDA and other relevant global regulatory authorities. Develop and direct regulatory strategies that support the objectives of the Company.

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

  • Identify, develop and implement appropriate regulatory strategies including submission strategies to support development of cell therapy products
  • In collaboration with project team members and management, develop and execute communication strategy with FDA and other regulatory agencies regarding study designs and issues related to current and future programs
  • Manage the preparation of regulatory submission packages and responses to regulatory inquiries. Author, in collaboration with other team members, key pieces of regulatory submissions.
  • Represent Lineage at regulatory meetings with the FDA and other agencies
  • Negotiate submission data requirements and deliverable dates with regulatory authorities and internal technical teams.

POSITION REQUIREMENTS:

Education and Experience:   

  • Bachelor’s degree in life sciences or other relevant field; advanced degree a plus
  • Minimum of 15 years related experience within the biotechnology or pharmaceutical industry. Experience in biologics, cell therapy, gene therapy, regenerative medicine, medical device or combination products (drug-device) highly desired.
  • Solid knowledge of global Health Authority laws, regulations, guidance, and regulation submission routes available for cell therapy products and combination products (biologics/devices)
  • Demonstrated experience in the submission of regulatory documents to support early- and late-stage clinical trials, including briefing documents, INDs, IDEs, IMPDs, CTAs, NDAs, DSURs, CSRs, etc.
  • Preference will be given to candidates with experience in oncology, immunology, or neurology

Knowledge and Skills:  

  • Excellent communication skills, both verbal and written. The ability to interface effectively with internal personnel at all levels, as well as external partners including the board of directors and the physician community.
  • Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
  • An assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done. Ability to influence people and be recognized as a leader.

Must be able to travel, including periodic international travel.

 

CLINICAL RESEARCH ASSOCIATE

Lineage is seeking a Clinical Research Associate to join our team. This is a full-time position, reporting to the Associate Director of Clinical Operations, working out of Lineage’s headquarters in Carlsbad, CA.

SUMMARY OF ESSENTIAL FUNCTIONS:

Provides support to clinical study teams in vendor oversight, investigational site management and other study related activities, including study start-up, interim study monitoring as well as trial closeout activities. Monitors progress of clinical studies at the site level and works to ensure that clinical standard operating procedures (SOPs), protocols, and documentation are in compliance with good clinical practice (GCP). Ensures and verifies the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents.

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

  • Support the efficient management of trials in all study phases (I-III) including assisting in recruitment of potential Investigators, preparation of Independent Ethics Committee / Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as needed
  • Perform pre-study visits, initiations and closeout visits in addition to routine monitoring visits
  • Train, with the support of the medical monitor investigators and other trial staff, in the protocol and data collection methods to ensure collection of subject data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICH-GCP and Lineage SOPs
  • Ensure site adherence to protocol, accurate data collection via comprehensive source document verification, and investigational product/biological samples/supplies accountability
  • Monitor and update data in an Electronic Data Capture (EDC) system in a timely manner and in accordance with study specific guideline
  • Communicate effectively with site personnel, including the Principal Investigator (PI), and Lineage management to relay protocol/study deviations and ensure timely implementation of corrective actions
  • Establish, update, track and maintain study specific trial management tools/systems, and status reports
  • Collect essential regulatory documents from sites and ensures that Trial Master Files for assigned projects are in adherence to global regulations and guidelines, company quality standards and SOPs
  • Support interaction with central IRB/EC and ensure collection and review of required essential study documents and reports
  • Identify and process Serious Adverse Events (SAEs) according to the procedures defined by the study team
  • Negotiate investigator budgets and assists with the execution of site contracts with support from the legal department
  • Ensure clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence
  • Support regulatory inspection activities as required
  • Participate in study-specific meetings, teleconferences and trainings
  • Participate in meetings or conference calls with CROs, CRAs and cross-functional study teams
  • Assist in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
  • May assist in development of protocols, informed consents, case report forms, monitoring plans, and edit specifications

POSITION REQUIREMENTS:

Education and Experience:

  • Bachelor’s degree or higher, preferably in a biologic/scientific discipline
  • Minimum of 1 year of experience as a Clinical Trial Assistant in the CRO and/or life sciences industry
  • Preference given to individuals with experience in neurology and oncology; Medical device experience is a plus

Knowledge and Skills:

  • Detailed knowledge of FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research
  • Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and site management/monitoring
  • Strong organizational, documentation and interpersonal skills as well as a willingness to work in a team-oriented environment
  • Ability to develop and maintain strong working relationship with Investigators and study staff
  • Ability to take initiative and work with limited direction
  • Strong analytical and problem-solving skills
  • Excellent interpersonal, written, verbal communication and administrative skills
  • Proficient with MS Word, PowerPoint, and Excel
  • Must be able to travel up to 25%, including international travel

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell 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.