Senior Director, Clinical Science

IDEAYA Biosciences • South San Francisco, CA

9d • $276,000 - $341,000 • Hybrid

About The Position

IDEAYA 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. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.

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 would thrive in a mentored rather than a directed environment.
The Senior Director will be able to take on new and varied activities and will enjoy participating 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, will be an excellent negotiator and will be able to manage other functions through a matrix structure.
The Senior 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.

This position is based in our South San Francisco offices and required to be onsite four days per week per our company policy.

Reporting to: Senior Vice President, Early Phase Clinical Development

Requirements

• Bachelor’s degree and strong knowledge of clinical oncology gained through previous clinical development experience are required.
• 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)
• Skilled in protocol design, interpretation, and medical monitoring
• 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.
• All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.
• Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

Nice To Haves

• Postgraduate qualification in clinical oncology (e.g., Masters degree) would be welcomed as would MD, Nurse Practitioner’s License, PharmD or PhD
• Experience in clinical trials with small molecules preferred
• Experience in assessment of adverse events and safety of patients participating in therapeutic clinical trials is preferred
• 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.

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 initial and or later drafts of protocol synopses, protocols and protocol amendments
• 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
• Writing/reviewing clinical/safety sections of NDAs/MAAs
• 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
• Support Health Authority (HA) interaction, accountable for providing 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.
• Additional study level activities might include presentation of study results to internal and external committees or advisory boards, presentation of data at international scientific meetings and publication of study results in peer-reviewed journals.
• 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.

Benefits

• merit-based salary increases
• company discretionary short-term incentive plan participation
• company discretionary stock option awards
• medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
• 401k
• ESPP
• wellness programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior