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, Courage and Collaboration and it reflects who we are and the environment we are creating.
 
You will be responsible for generating and collaborating to define clinical strategy, working with investigators on the clinical studies, and interpreting clinical data.

KEY ROLE AND RESPONSIBILITIES:

  • Support of clinical trial design and the development of specific study concept sheets and protocols
  • Summarize scientific information in new therapeutic areas from published literature to integrate into new study development
  • Works in close coordination with the Medical Director(s) and Clinical Operations on assigned clinical programs and individual studies. May serve as the clinical representative on individual study teams as needed
  • In collaboration with Clinical Operations and Medical Writing, prepares scientific aspects of study protocols, amendments, specific sections of study manuals and Investigator meeting materials, and other documents as needed with guidance and supervision
  • Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations
  • Conducts scientific literature reviews and compile reports according to specifications provided e.g. annual literature updates and periodic safety updates
  • Develop scientific and clinical knowledge in the relevant disease and therapeutic area(s) as requested. Including integrating information on disease pathogenesis, etiology, epidemiology and current treatment paradigms.
  • Conducts a review of published literature or of clinical and preclinical reports in the field to provide the context for clinical development programs
  • Development and review of scientific and technical documents, including clinical protocols, clinical study reports, analysis plans, drug development plans, scientific publications (abstracts, posters, presentations, manuscripts), and others
  • Supports Regulatory document generation and review, including pharmacokinetic/pharmacodynamic reports, Investigational New Drug applications (INDs), marketing applications, Investigator Brochures, FDA meeting requests and briefing documents

PREFERRED EDUCATION:

  • BA/BSc in biology with a minimum of 10 years’ experience; or
  • MSc with a minimum of 8 years’ experience; or
  • PhD, PharmD with a minimum of 5 years’ experience

 PREFERRED EXPERIENCE:

  • Minimum of 7 years of clinical trial experience in the pharma/biotech industry
  • Preference for experience across all stages of clinical development from Phase I to Phase III
  • Preference for experience in oncology and/or cell therapy clinical development
  • Prior experience filing BLAs, MMAs, or NDAs is a plus
  • Capability to enter a new therapeutic area (with guidance) and summarize scientific information that is available in the published literature to integrate into new study development
  • Demonstrated experience authoring clinical study reports or other regulatory documents (e.g., eCTD nonclinical, clinical, or quality/CMC summaries) in support of FDA, EMA, or similar regulatory body submission

KNOWLEDGE, SKILLS AND ABILITIES:

  • Team player who is comfortable working simultaneously across cross functional project team (or equivalent)
  • Excellent written and verbal communication skills as well as the ability to communicate complex scientific concepts and technical details to team members, clients, and regulatory authorities
  • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
  • Demonstrated strength of interpersonal skills with the ability to build solid internal and external relationships
  • Excellent attention to detail
  • Ability to work with minimal supervision and goal oriented
  • Demonstrated experience in developing and authoring clinical development plans and study protocols
  • Proficient in medical terminology and medical writing skills.
  • Deep knowledge of GCP, ICH, and FDA guidelines
 
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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