Associate Director, Data Management - South San Francisco, United States - IDEAYA Biosciences

Description

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

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Position Summary:
IDEAYA is seeking a talented and highly motivated Associate Director of Data Management (DM).

This individual will be responsible for leading clinical data activities across multiple studies from study start-up to study closure for IDEAYA's early and late-stage clinical programs.

As an Associate Director, you will play a key role in leading data management activities for one or more oncology clinical studies, ensuring complete, accurate and high-quality data collection.

In addition, you will provide leadership within the organization to develop and implement clinical data management standards and processes.

You should enjoy working with a dynamic and multi-disciplinary team and be able to work independently and collaboratively with key functions both internally and externally.

What you'll do:
Provide leadership for clinical data management (CDM) function; ensure DM deliverables are completed on time, within budget and in accordance with quality standards and study requirements
Responsible for leading CDM activities for one or more oncology clinical studies; responsible for the oversight of CRO and/or CDM vendors to ensure that project goals are achieved and overseeing adherence to scope of work and service agreements
Establish and maintain strong relationships with internal cross-functional teams, vendors and clinical research site personnel for

successful execution of clinical trial
Lead the development of EDC data review listings, SAS clinical programming report specifications and data visualization outputs
Write or contribute to preparation of CDM documents (e.g., Case Report Form [CRF] completion guidelines, annotated CRFs, CRF and data validation specifications, data transfer agreements, data management plan and data review plan)

Lead and oversee Electronic Data Capture (EDC) build, modifications and deployment including creation and execution of User Acceptance Testing (UAT) plans and test scripts, and implementation of data integrations with external vendor data sources (e.g.

, IRT, laboratory, Imaging)
Oversee set-up of other clinical management systems (e.g., IRT) and data transfer agreements with external vendors
In collaboration with Study Management Team (SMT), participate in clinical document review such as clinical protocols, statistical analysis plans, protocol deviation plans, mock Tables, Figures and Listings (TFLs)
Report DM metrics and trends; identify barriers to timely and successful trial execution and propose solutions
Lead clinical data review of data listings and summary tables with the SMT
Implement data review strategy via use of data integration or visualization platform
Serve as a subject matter expert on CDM systems and processes
Lead CDM standardization and development of Standard Operation Procedures (SOPs), work instructions and other infrastructure as needed; may include standard CDASH case report form library and associated edit checks

Requirements:
Bachelors in life sciences or related discipline with 10-12 years of experience in clinical data management
CRO or CDM vendor management experience
Late-phase oncology clinical data management experience preferred
Line management experience is a plus
Veeva CDMS experience is a plus
Experience with CDASH terminology and/or MedDRA and WhoDrug medical coding
Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines
Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization
Self-motivated and takes pride in your work
Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships
Attention to detail, ability to proactively identify issues and address with solutions-oriented approach
$191,900 - $208,723 a year

The salary range is an estimate and may vary based on the Company's compensation practices.

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.

Benefits

Along 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.

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