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, writing clinical development concepts and plans for molecules at all stages of development but more focused on early oncology development
• Writing/reviewing informed consent forms and reviewing/adjudicating site-specific ICF requests
• Partnering with Clinical Operations on site selection, start-up and communication
• Writing or updating clinical sections of investigator brochures and leading the team that writes the initial brochure and subsequent annual updates
• Representing the medical (clinical) function on one or more clinical study teams, with functional support from the clinical leader
• Serving as a member of the clinical sub team
• Reviewing and interpreting data listings including safety data and serious adverse events
• Assisting with or serving as primary 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
• Organizing and participating in opinion leader advisory boards
• Contributing to or performing therapeutic area/indication research and competitor analysis
• Building and maintaining opinion leader/investigator networks
• Supporting Health Authority (HA) interaction, accountable for providing responses to HA inspection observations and internal audits
• Supporting HA updates and submissions
• Aiding 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

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.

Skills

• Fluency in English is required.

Benefits

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.

We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at hr@ideayabio.com.