Taiho Oncology

  • VP, Biomarker and Companion Diagnostic Development

    Job Locations US-NJ-Princeton
    Category
    Scientific Services
    Travel
    15-20%
    Type
    Regular Full-Time
  • Position Summary

    Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy.

     

    In collaboration with TPC’s research organization, this position has responsibility for the identification and selection of clinical biomarkers (predictive and pharmacodynamic) to be incorporated into early stage clinical trials and, where appropriate, for the further development, registration and approval of these biomarkers as companion diagnostics. 

    Responsibilities

    • Design of biomarkers strategy in collaboration with Taiho Japan (TPC)
    • Execute translational and biomarkers aspects within early Phase1-studies in the US and EU.
    • Liaise with Clinical Development MDs and external KOLs in implementing these strategies.
    • Direct operational aspects of predictive and pharmacodynamic biomarkers deployment (eg kits, tracking, timely analysis etc)
    • Analyze and interpret biomarker results from Taiho’s early clinical studies
    • Creating/reviewing and editing biomarkers aspects in various documents and regulatory submissions.
    • Develop Companion Diagnostic strategy for relevant compounds.
    • Where appropriate, in collaboration with Clinical Development, this position will lead the identification, evaluation and selection process for a Companion Diagnostic partner company.
    • Where appropriate, this position will work directly with the Companion Diagnostic partner company to ensure the simultaneous development and registration via a PMA or equivalent, of all companion diagnostic tests/devices required for use with Taiho Oncology products, including such activities as contracting, document review and approval, vendor oversight, budget development, budget management and dispute resolution.

    Qualifications

    Educational Requirements:   

    • MD or PhD with Oncology training/experience in the relevant fields.

     

    Experience: 

    • A minimum 7 years’ experience in oncology drug development with meaningful experience in companion diagnostic development spanning IDE to PMA submission. 

    Other Skills and Abilities:

    • Extensive knowledge of the oncology drug development and device development process in the USA and EU is required.
    • Experience in direct interactions with US and/or EU Regulatory authorities, particularly with CDRH is necessary.
    • Highly detailed and quality oriented.
    • Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members.
    • Ability to understand and prioritize deliverables as well as recognize and resolve conflicts in priorities
    • A positive attitude, flexibility and a proactive thought process.

    Language Skills:

    • Ability to read, analyze and interpret scientific and technical information and data.
    • Excellent written and oral communication skills.

    Mathematical Skills:

    • Ability to work with mathematical concepts such as probability and statistical measures.

    Reasoning Ability:

    • Ability to define problems, collect data, establish facts, and draw valid conclusions.
    • Ability to interpret an extensive variety of technical information and deal with several abstract and concrete variables.

    Computer Skills:

    • Strong computer skills in MS Office products.

    Physical Demands: 

    • While performing the duties of this job, the employee is frequently required to sit, talk and hear.
    • The employee is occasionally required to walk.
    • Must be able to travel domestically and internationally on a reasonably frequent basis (approx. 15-20% of time including some weekend travel).

    Work Environment: 

    • The noise level in the work environment is usually quiet. The noise level in the office work environment is usually quiet.
    • Domestic and international travel includes spending time at cancer trial sites/institutions, conference cetners, offices and hotels. 

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    The incumbent in this position may be required to perform other duties, as assigned.

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