Director, Clinical Science

About the role

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.

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
• 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
• Aiding 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

Requirements

• Bachelor’s degree and strong knowledge of clinical oncology gained through previous clinical development experience are required.
• Postgraduate qualification in clinical oncology (e.g., master’s degree) would be welcomed as would MD, Nurse Practitioner’s License, PharmD or PhD.
• 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.

Qualifications

• Fluency in English is required.

Personal Qualities

• The successful candidate will be a confident person keen to take responsibility for assigned activities.
• Although working under the guidance of a manager and the clinical leader of the program, the Director will be expected to function independently and would thrive in a mentored rather than a directed environment.
• The Director will feel comfortable presenting data to peers, investigators and senior management/executive committee.
• They will be able to embrace the challenges and opportunities offered in a small company environment and to capitalize on the experience.

Total Rewards

• 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).
• The Company complies with all laws respecting equal employment opportunities 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 in the office at the Company’s facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as 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.
• The Company is an equal opportunity employer. In accordance with applicable law, the Company does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status.