Senior Director, Clinical Science

IDEAYA Biosciences is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology, and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease.

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. 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 Senior Director will be expected to function largely independently and thrive in a mentored rather than a directed environment.

The Senior Director will take on new and varied activities and participate at every level of the project, ranging from detailed review of documents/data through to strategic program planning. They will be committed to working within a project team structure, be an excellent negotiator, and manage other functions through a matrix structure. This position is based in South San Francisco and requires onsite presence four days per week per company policy.

Responsibilities

• With the clinical leader, write clinical development concepts and plans for molecules at all stages of development, with a focus on early oncology development
• Write initial and/or later drafts of protocol synopses, protocols, and protocol amendments
• Write/review informed consent forms and review/adjudicate site-specific ICF requests
• Partner with Clinical Operations on site selection, start-up, and communication
• Write or 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
• Assist with or serve as primary author of clinical study reports and associated publications
• Create clinical study- or program-related slide decks for internal and external use
• Train colleagues, CRO, and study site staff on the therapeutic area, molecule, and protocols as appropriate
• 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, provide responses to HA inspection observations, and internal audits
• Support HA updates and submissions
• Assist 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
• Present study results to internal and external committees or advisory boards, present data at international scientific meetings, and publish study results in peer-reviewed journals
• 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., Master’s degree) would be welcomed, as would MD, Nurse Practitioner’s License, PharmD, or PhD
• At least 4 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)
• 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
• 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

Benefits

• Comprehensive medical/dental/vision coverage (100% company-paid for employees and 90% company-paid for dependents)
• 401k and Employee Stock Purchase Plan (ESPP)
• Wellness programs
• Eligibility for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval)

Pay

The expected salary range for the role of Senior Director, Clinical Science is $276,000 - $341,000. The final salary offered will depend on several factors including but not limited to location, experience, disease area expertise, industry tenure, educational background, and performance during the interview process.

Schedule

This position requires onsite presence in South San Francisco four days per week per company policy, with work-from-home flexibility.