Director, Clinical Science

IDEAYA BiosciencesSouth San Francisco, CA
1d$227,000 - $280,000Onsite

About The Position

IDEAYA Biosciences is seeking a South San Francisco based experienced, motivated, outgoing Clinical Scientist. Reporting to the Sr. Medical Director, Late-Stage Clinical Development, the Director will work closely with the clinical leader providing medical and -scientific expertise to one or more clinical projects. This position is based in our South San Francisco headquarter office and required to be onsite four days per week per our company policy.

Requirements

  • Bachelor’s degree and strong knowledge of clinical oncology gained through previous clinical development experience are required.
  • At least 2 years of industry experience in oncology
  • Previous participation in a clinical development program is essential, preferably involvement in all stages of clinical trials (i.e., from start up to study report)
  • Skilled in protocol design, interpretation, and data cleaning.
  • Experience in assessment of adverse events and safety of patients participating in therapeutic clinical trials is preferred
  • Knowledge of Good Clinical Practice
  • Excellent written and oral communication
  • Capacity to adapt to a fast-paced and changing environment
  • Fluency in English is required.

Nice To Haves

  • Postgraduate qualification in clinical oncology (e.g., master’s degree) would be welcomed as would MD, Nurse Practitioner’s License, PharmD or PhD

Responsibilities

  • With the medical monitor (MM), writing clinical development concepts and plans for molecules at all stages of development
  • With the medical monitor, writing initial and or later drafts of protocol synopses, protocols and protocol amendments
  • Reviewing informed consent forms and reviewing/adjudicating site-specific ICF requests
  • Partnering with the MM and Clinical Operations on site selection, start-up and communication activities
  • With the medical monitor writing or updating clinical sections of investigator brochures
  • Reviewing clinical/safety sections of NDAs/MAAs
  • Serving as a member of the clinical sub team
  • Reviewing and interpreting data listings including safety data and serious adverse events
  • Assisting the MM as an author of clinical study reports and associated publications
  • Creating clinical study- or program-related slide decks for internal and external use
  • Training of colleagues, CRO and study site staff on the therapeutic area, molecule and protocols as appropriate
  • With the MM organizing and participating in opinion leader advisory boards
  • Contributing to or performing therapeutic area/indication research and competitor analysis
  • With the MM support Health Authority (HA) interaction, accountable for providing responses to HA inspection observations and internal audits

Benefits

  • Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval).
  • Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.
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