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Senior Director, Clinical Data Management

IDEAYA Biosciences

IDEAYA Biosciences

This job is no longer accepting applications

See open jobs at IDEAYA Biosciences.
Sales & Business Development, Data Science
South San Francisco, CA, USA
Posted on Saturday, January 13, 2024
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.
The Senior Director, Clinical Data Management, reports to the Vice President, Biometrics, and is accountable for data management activities, data quality, and integrity for all IDEAYA clinical programs. The incumbent will be a dynamic leader, with proven track record in driving strategic initiatives, fostering cross-functional collaboration, and achieving company goals. Identify and drive implementation of industry data management best practice solutions to ensure timely execution of data deliverables. Bring expertise in implementing robust data governance frameworks, successful team management, and comprehensive understanding of regulatory requirements.

What you'll do:

  • Drive development and adherence to clinical data management vision, strategy, and operational excellence for global development programs.
  • Drive development and improvement of department-level standard operating procedures (SOPs), work instructions (WIs), for electronic case report forms (eCRF), eCRF completion guidelines, data transfer and handling agreements, data management and data review plans.
  • Ensure all data management activities and processes follow Good Clinical Practice (GCP), relevant regulatory requirements, and SOPs and WIs.
  • Ensure compliance with Clinical Data Interchange Standards Consortium (CDISC) standards to ensure high data quality standards.
  • Anticipate new challenges, risks, and needs for the department, and proactively mitigate to ensure business continuity.
  • Accountable to oversee performance of external vendors responsible for clinical data deliverables to ensure quality completion of all clinical data related deliverables.
  • Responsible for identification and hiring of data management resources in accordance with program budget and timelines.
  • Responsible for resource allocation, ensuring that trials are supplied with appropriate clinical data management resources to meet business needs.
  • Oversee and manage data management and clinical programming resources, providing specific expertise on timelines development and deliverables related to clinical data.
  • Lead and contribute to clinical data related vendor identification through development and distribution of RFI/RFP and bid defense discussions in collaboration with cross-functional partners.
  • Develop in consultation with cross-functional partners clinical data related key performance indicators (KPIs) to support contractual agreements.
  • Participate in the development of the clinical components of regulatory submissions and transfer of clinical data as needed, ensure data deliverables meet regulatory submission requirements.
  • Oversee departmental budget and provide recommendations for efficiencies and cost savings.
  • Adeptly advocate for departmental decision-making involvement in key company and team deliverables.
  • Regularly mentor staff.
  • Responsibly delegate tasks.
  • Manage internal and external audits.

Requirements:

  • Bachelor’s degree or higher in arts or science preferably health-related field
  • Eight years’ experience within clinical data management, understanding of process including study management, CRO, and vendor management.
  • CRF design, database set-up, edit check specification, data review and data cleaning activities.
  • Extensive knowledge of FDA, GCP and other regulations’ requirements in respect to clinical data quality and clinical trials conduct.
  • Effective team leadership in cross-functional study and program teams.
  • Excellent ability to manage, motivate, develop, and empower staff.
  • Excellent ability to manage competing priorities in a changing environment.
  • Superior verbal and written communication and relationship-building skills.
  • Superior organizational skills.
  • Optional: technical database expertise and technical training experience.
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. EOE/AA/Vets.

This job is no longer accepting applications

See open jobs at IDEAYA Biosciences.