Associate Director, Clinical Biomarker Development & Operations

Location
South San Francisco, CA
Posted
Sep 30, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
About IDEAYA Biosciences:
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage synthetic lethality-focused 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 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.

Position Summary:

Lead and manage a team of biomarker scientists supporting clinical stage programs on biomarker assay development and implementation in the clinic
Provide and oversee biomarker analyses using a deep biological understanding of mechanisms of action and cancer biology to support clinical-stage programs
Work closely with Clinical Development Teams to implement and interpret data from established and novel biomarker analyses in clinical samples including pharmacodynamic, predictive and diagnostic biomarkers
Establish and oversee relationships with external analytical labs, CROs and vendors to support biomarker assay development and implementation in the clinic
Lead and oversee drafting and amendment of biomarker-related sections in clinical study-related and regulatory documents (such as clinical protocols, ICFs, INDs, IBs, clinical study reports) as well as publications (external presentations, manuscripts)
Oversee and manage clinical biomarker scientist leading clinical biomarker sample management efforts specific to biomarker sample collections, analyses, data transfers, and that reporting is performed in accordance to the study protocol and in compliance with regulatory requirements
Oversee and manage translational scientist leading clinical biomarker assay development and implementation in the clinical setting

What you'll do:

    • Oversee and lead interpretation of pathway biomarker data in clinical and preclinical samples from targeted (including flow cytometry, qPCR, ELISA, IHC) and untargeted (proteomic, metabolomics and transcriptomic) techniques
    • The successful candidate will lead and manage a team of biomarker scientists who extensively work on critical evaluation of clinical findings to validate novel biomarkers, potential indications, and patient stratification strategies for our pipeline programs
    • Working with, setting up, and/or managing collaborations and regulatory document amendments in support of clinical programs
    • Establish connections with a network of CROs to support biomarker work within a collaborative multidisciplinary environment
    • Present and mentor scientists to present results and interpretation to scientific, company and leadership teams in the company

Requirements:

    • BS/MS in Cell or Molecular Biology (or a related discipline) with 5+ years industry experience in the field of clinical biomarkers within oncology with experience in development of companion diagnostic assays
    • Experience in performing and critically analyzing and interpreting clinical data from different transcriptomic and proteomic techniques
    • Ability to manage a team of scientists and work collaboratively in a highly dynamic environment
    • Proven ability to work in the teams, with demonstrated ability to effectively communicate and resolve issues
    • Possess a high level of critical scientific thinking, motivation, and a strong desire to learn new concepts and methods
    • Ability to balance execution of tasks required to accomplish goals while creating an environment of scientific curiosity and open exchange of ideas
    • Display good attitude to team members, the drive to innovate and think creatively with courage, integrity and respect

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 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
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.