Clinical Operations
South San Francisco, California, United States
01/23/23

Clinical Compliance Lead

At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage and it reflects who we are and the environment we are creating.

This position can be located in Seattle, WA or South San Francisco, CA

POSITION SUMMARY:

This role is accountable for the day-to-day work to support Lyell’s Clinical Operations teams with the conduct of clinical trials to comply with all internal and external standards (laws, regulations, directives, guidance, etc.) that are applicable to their activities. This role works closely cross-functional with Clinical Development and Development Quality Assurance (Dev QA) to anticipate and prevent issues that may impact clinical trial compliance.

KEY ROLE AND RESPONSIBILITIES:

  • Participates in the development of clinical trial protocols and clinical study plans, study specific templates, forms, logs and trackers
  • Coordinates with Dev QA on the creation/revision/retirement of Clinical Operations: SOPs/policies, Templates and Forms, to include versioning and filing
  • Creates tools and training material to support Clinical Operations functions
  • Participates in the identification of CROs and centralized services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities and participates in final vendor selection
  • Supports Clinical Trial Manager(CTM) and Clinical Research Associates (CRAs) with the development of site-specific Risk Mitigation Plans for clinical sites
  • Conducts routine compliance checks on Trial Master File (TMF) and associated records for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required. Provide report CTM and Dev QA.
  • Conducts routine review of Monitoring Visits Reports for compliance, audit readiness, review action item and queries and timeliness of resolution. Provide report CTM and Dev QA.
  • Communicates with CTM, CRAs and Dev QA regarding Investigators and clinical site staff on potential issues related to protocol conduct, protocol deviations, regulatory compliance, site audits/inspections support and coordinates resolutions with relevant team members
  • Supports Lyell audit/regulatory inspection readiness and hosting of audits/inspections. Provides guidance at the clinical site and Project Team level towards audit readiness in coordination with Dev QA on and supports preparation for audit/inspection and any required post-audit follow-up actions
  • Supports Dev QA on CRO/vendor and/or internal audits and assessments
  • Assists with CRO/vendor KPI (Key Performance Indicators) tracking and other compliance metrics and provides reports to Dev QA
  • Leads clinical trial-related and Lyell procedural Deviation and CAPA management for Clinical Operations and collaborates with Dev QA on resolution, follow-up, and close-out
  • Reports clinical trial-related quality events, incidents and relevant queries to Dev QA according to applicable SOPs
  • Prepares and assists in preparing quality event trending reports for Clinical Operations with Dev QA
  • Represents Clinical Operations on the pan Lyell Training Committee
  • Represents Clinical Operations on the pan Lyell Document Management Committee
  • Leads and partakes in regular team meeting / teleconferences; Participate/present at CRO, Vendor and Investigator Site meetings as necessary; Participate/present at Site and Investigator Meetings as necessary
  • Works with the cross-functional Study Teams as needed; frequent cross-functional interactions with internal and external personnel (e.g., CRO, Vendors, Dev QA, Regulatory, Investigators Sites, vendors, etc.).
  • Interacts frequently with Clinical Operations management and members of the cross-functional clinical study team

PREFERRED EDUCATION:

  • BSc in biomedical sciences or related field with a minimum of 11 years’ experience
    in a clinical compliance or quality role; or
  • MSc in biomedical sciences or related field with a minimum of 9 years’ experience
    in a clinical compliance or quality role

PREFERRED EXPERIENCE:

  • Demonstrated experience working with cross-functional teams
  • Extensive experience working with clinical protocols
  • A proven experienced, strong collaborator, effective at influencing internally and externally, and proactive in a fast-paced environment
  • Work experience in a highly regulated environment (ICH/GCP)

KNOWLEDGE, SKILLS AND ABILITIES:

  • Oncology Experience
  • Cell therapy Experience
  • Excellent verbal and written communication skills required.
  • Excellent organizational, multi-tasking and time management skills required.
  • Sound knowledge of medical terminology and clinical trial management process.
  • Knowledge of FDA regulations 21 CFR 11, 50, 54, 56, 58, 312, and 812 as well as International Council for Harmonization (ICH) Good Clinical Practice guidelines

Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.

The salary range for this position is $128,000 to $160,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.

Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days’ vacation, 9 day’s sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown. More information on our extensive benefits offering can be found on our company website, www.lyell.com

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.

Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.

 

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