Senior Director, Clinical Science

IDEAYA Biosciences•South San Francisco, CA

3d•$276,000 - $341,000•Hybrid

About The Position

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.

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)
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
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
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.