IDEAYA Biosciences
Director/Senior Director, Clinical Science
IDEAYA Biosciences, San Diego, California, United States, 92189
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology 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 has an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs.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 .Position Summary:IDEAYA Biosciences is seeking a South San Francisco or San Diego based experienced, motivated, outgoing Clinical Scientist. The Director/Senior Director will work closely with the clinical leader providing medico-scientific expertise to one or more clinical projects.This position is based in our South San Francisco or San Diego offices and required to be onsite four days per week per our company policy. Local candidates only.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 developmentWriting initial and or later drafts of protocol synopses, protocols and protocol amendmentsWriting/reviewing informed consent forms and reviewing/adjudicating site-specific ICF requestsPartnering with Clinical Operations on site selection, start-up and communicationWriting or updating clinical sections of investigator brochures and leading the team that writes the initial brochure and subsequent annual updatesWriting/reviewing clinical/safety sections of NDAs/MAAsRepresenting the medical (clinical) function on one or more clinical study teams, with functional support from the clinical leaderServing as a member of the clinical sub teamReviewing and interpreting data listings including safety data and serious adverse eventsAssisting with or serving as primary author of clinical study reports and associated publicationsCreating clinical study- or program-related slide decks for internal and external useTraining of colleagues, CRO and study site staff on the therapeutic area, molecule and protocols as appropriateOrganizing and participating in opinion leader advisory boardsContributing to or performing therapeutic area/indication research and competitor analysisBuilding and maintaining opinion leader/investigator networksSupport Health Authority (HA) interaction, accountable for providing responses to HA inspection observations and internal auditsSupport HA updates and submissionsAdditional 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.
Requirements:
Bachelor’s degree and strong knowledge of clinical oncology gained through previous clinical development experience are required. Training and experience in immuno-oncology desiredPostgraduate qualification in clinical oncology (e.g., Master’s degree) would be welcomed as would MD, Nurse Practitioner’s License, PharmD or PhDAt least 2 years of industry experience in oncologyPrevious 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 preferredSkilled in protocol design, interpretation, and medical monitoringExperience in assessment of adverse events and safety of patients participating in therapeutic clinical trials is preferredKnowledge of Good Clinical PracticeExcellent written and oral communicationCapacity to adapt to a fast-paced and changing environmentCandidates 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.
$241,836 - $271,008 a year
At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco/San Diego, California office is $241,836 -$271,008. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.The Company complies with all laws respecting equal employment opportunity 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 at the Company’s facilities,
with partial work-from-home flexibility,
and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise 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.BenefitsAlong with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh.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.California Job Applicant Privacy Notice
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www.ideayabio.com .Position Summary:IDEAYA Biosciences is seeking a South San Francisco or San Diego based experienced, motivated, outgoing Clinical Scientist. The Director/Senior Director will work closely with the clinical leader providing medico-scientific expertise to one or more clinical projects.This position is based in our South San Francisco or San Diego offices and required to be onsite four days per week per our company policy. Local candidates only.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 developmentWriting initial and or later drafts of protocol synopses, protocols and protocol amendmentsWriting/reviewing informed consent forms and reviewing/adjudicating site-specific ICF requestsPartnering with Clinical Operations on site selection, start-up and communicationWriting or updating clinical sections of investigator brochures and leading the team that writes the initial brochure and subsequent annual updatesWriting/reviewing clinical/safety sections of NDAs/MAAsRepresenting the medical (clinical) function on one or more clinical study teams, with functional support from the clinical leaderServing as a member of the clinical sub teamReviewing and interpreting data listings including safety data and serious adverse eventsAssisting with or serving as primary author of clinical study reports and associated publicationsCreating clinical study- or program-related slide decks for internal and external useTraining of colleagues, CRO and study site staff on the therapeutic area, molecule and protocols as appropriateOrganizing and participating in opinion leader advisory boardsContributing to or performing therapeutic area/indication research and competitor analysisBuilding and maintaining opinion leader/investigator networksSupport Health Authority (HA) interaction, accountable for providing responses to HA inspection observations and internal auditsSupport HA updates and submissionsAdditional 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.
Requirements:
Bachelor’s degree and strong knowledge of clinical oncology gained through previous clinical development experience are required. Training and experience in immuno-oncology desiredPostgraduate qualification in clinical oncology (e.g., Master’s degree) would be welcomed as would MD, Nurse Practitioner’s License, PharmD or PhDAt least 2 years of industry experience in oncologyPrevious 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 preferredSkilled in protocol design, interpretation, and medical monitoringExperience in assessment of adverse events and safety of patients participating in therapeutic clinical trials is preferredKnowledge of Good Clinical PracticeExcellent written and oral communicationCapacity to adapt to a fast-paced and changing environmentCandidates 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.
$241,836 - $271,008 a year
At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco/San Diego, California office is $241,836 -$271,008. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.The Company complies with all laws respecting equal employment opportunity 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 at the Company’s facilities,
with partial work-from-home flexibility,
and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise 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.BenefitsAlong with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh.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.California Job Applicant Privacy Notice
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