Senior Director, Clinical Science

About the role

IDEAYA Biosciences is seeking an experienced, motivated, outgoing Senior Director of Clinical Science to work closely with the clinical leader providing medical-scientific expertise to one or more clinical projects.

Responsibilities

• With the clinical leader, write clinical development concepts and plans for molecules at all stages of development but more focused on early oncology development
• Write/review informed consent forms and review/adjudicate site-specific ICF requests
• Partner with Clinical Operations on site selection, start-up and communication
• Write/update clinical sections of investigator brochures and lead the team that writes the initial brochure and subsequent annual updates
• Write/review clinical/safety sections of NDAs/MAAs
• Represent the medical (clinical) function on one or more clinical study teams, with functional support from the clinical leader
• Serve as a member of the clinical sub-team
• Review and interpret data listings including safety data and serious adverse events
• Create clinical study- or program-related slide decks for internal and external use
• Organize and participate in opinion leader advisory boards
• Contribute to or perform therapeutic area/indication research and competitor analysis
• Build and maintain opinion leader/investigator networks
• Support Health Authority (HA) interaction, accountable for providing responses to HA inspection observations and internal audits
• Support HA updates and submissions
• Aid Medical Monitor for Phase 1 clinical trials, accountable to the clinical lead for patient safety and providing guidance during the design, execution, and reporting for clinical studies
• In addition to study level activities, the Director/Senior Director will participate in program level activities including authoring/reviewing safety and efficacy summaries, clinical overviews, investigator brochures, risk management plans, periodic safety updates and clinical sections of product labels

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., Masters degree) would be welcomed as would MD, Nurse Practitioner’s License, PharmD or PhD.
• 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).
• Experience in clinical trials with small molecules preferred.
• Skilled in protocol design, interpretation, and medical monitoring.
• 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

• Candidates with a background in closely related functions (e.g., clinical operations, regulatory affairs, biometrics), having represented their function at project/clinical team level, would also be considered.
• Fluency in English is required.

Skills

• Strong leadership and negotiation skills.
• Ability to work independently and in a team environment.
• Excellent interpersonal and communication skills.
• Ability to manage multiple projects simultaneously.
• Strong organizational and prioritization skills.

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).

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.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA 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.