Director/Senior Director, Clinical Science
About IDEAYA Biosciences:
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response.
IDEAYA recently announced a landmark strategic partnership with GSK in Synthetic Lethality for certain pipeline programs. The GSK partnership is transformative and enables IDEAYA and GSK to collectively build an industry leading platform and pipeline in Synthetic Lethality. For more information, please see www.ideayabio.com.
IDEAYA Biosciences is seeking a South San Francisco based experienced, motivated, outgoing Clinical Scientist. Reporting to the VP, Head of Clinical Oncology, the Director/Senior Director will work closely with the clinical leader providing medico-scientific expertise to one or more clinical projects.
What you’ll do:
Typical activities may include but will not necessarily be limited to:
- With the clinical leader, writing clinical development concepts and plans for molecules at all stages of 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
- Act as Medical Monitor for Phase 1 clinical trials, accountable to the clinical lead/CMO for patient safety and provide medical guidance during the design, execution, and reporting for clinical studies.
Additional study level activities 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.
- Bachelor’s degree and strong knowledge of clinical oncology gained through previous clinical development experience are required. Training and experience in immuno-oncology desired
- Postgraduate qualification in clinical oncology (e.g., Masters degree) would be welcomed as would MD, Nurse Practitioner’s License, PharmD or PhD
- At least 2 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.
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 Director/Senior Director will be expected to function largely independently and would thrive in a mentored rather than a directed environment.
The Director/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 Director/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.
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.
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. EOE/AA/Vets.