Career Opportunities in Immunotherapy

Join our growing team of individuals dedicated to collaboration, life-long learning and seeing a day in which people with cancer live markedly longer and better lives. Syndax Pharmaceuticals, Inc. offers a competitive salary and benefits package. Qualified candidates should submit their resume and cover letter with a statement of interest, availability, and experience in Word or PDF format to: [email protected]. Syndax is an Equal Opportunity Employer.

 

  • Accountant

    Position Reports to: Controller

    Position Purpose:
    Accounts Payable and Contract Approval Administration

    Position Responsibilities

    • Open and date stamp all incoming mail;
    • Deposit all miscellaneous cash receipts;
    • Create and maintain all accounts payable-related files;
    • Enter invoices into the general ledger system ensuring proper account coding and invoice approvals;
    • Reconcile AP GL to AP detailed aging and explain all invoices aged greater than 60 days.
    • Maintain fixed asset ledger, fixed asset account reconciliation, and roll-forward.
    • Assist with weekly payment runs and follow up, as scheduled, on all invoices on hold to ensure timely payment;
    • Form 1099 maintenance;
    • Follow up on any items in dispute to ensure timely resolution;
    • Ensure all business expenses are accurately reported, have sufficient supporting documentation and are in accordance with the Company’s business expense policy;
    • Manage the Contract Approval process;
    • Support the month-end and quarter-end closing processes, as needed;
    • Manage the Contract Approval process;
    • Assist in other projects, as required;

     
    Position Requirements (Skills, Knowledge, Education and Work Experience)

    • Bachelor’s degree in business and/or accounting.
    • At least 2 years of successful accounting experience.
    • Excellent organizational skills; able to adapt to multiple priorities in a fast-paced and fluid work environment.
    • Excellent computer skills, including Microsoft Office Suite: Calendar, Word, and Excel are essential; knowledge of NetSuite a plus.
    • Strong work ethics.
    • Outstanding attention to detail; detail oriented.
  • Clinical Trial Associate

    Status: Exempt
    Reports to: AD, Clinical Operations, Associate VP Clinical Operations

    Position Description:

    The CTA will work with the AD Clinical Operations, Associate VP Clinical Operations to support the conduct of clinical trials. The CTA may provide support for various clinical trials and may manage certain aspects of the clinical trials. The CTA will partner with the Clinical Project Managers to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.

    Responsibilities and Duties:

    • Maintain the Trial Master Files (TMF): Responsible for the on-going management of the TMF for assigned clinical trials. This is inclusive of receipt, review, QC, tracking and filing of all documents per the Syndax SOPs required within the conduct of assigned clinical trials.
    • Responsible for assisting in the oversight of our external eTMF provider
    • Ensure all TMF documents are up to date such as 1572’s CV’s and Investigator Medical Licenses’
    • Assist with the development and maintenance of tracking tools for patient recruitment, site ramp-up, monitoring visits and site payments
    • In collaboration with the CPM’s is responsible for assisting in the creation in study materials such as study binders, manuals, laboratory manuals and pharmacy manuals
    • Work with Clinical Operations to assist in the oversight of CROs, as appropriate, to ensure the successful conduct of clinical trials, including attending and participating in Clinical Trial Working Groups as needed
    • Assist in reviewing monitoring visit reports to ensure proper conduct and oversight as needed
    • Reviews site-specific Informed Consent Forms
    • Tracks site feasibility questionnaires
    • Track study drug expiration dates and ensure sites have adequate supply based on protocol requirements
    • Facilitate the receiving, processing and tracking of Investigational Product shipments across all trials
    • Assist in the planning of various meetings and events for the Clinical Operations group
    • Reconcile invoices to their corresponding contracts and budget, and assist with investigator site payments
    • Prepares and manages study communications including newsletters and study updates
    • Records, prepares and distributes meeting minutes for assigned clinical trials or as designated by the VP of Clinical Operations

     
    Minimum Requirements:

    • Three or more years’ experience in clinical operations- experience in both a CRO and Sponsor setting desired. Oncology experience preferred
    • Knowledge of FDA regulatory requirements and ICH/GCP guidelines essential
    • Demonstrated efficiency in partnering with CROs and vendors
    • Computer proficiency (Word, Excel, PowerPoint, Project)
    • Works proactively and efficiently in a fast-paced, high change environment
    • Excellent written and oral communication skills
    • Outstanding organization skills
    • Ability to travel 25%
    • Bachelors; RN or BSN preferred
  • Senior Director, Clinical Research & Development

    Position Reports to: Sr. Vice President, Chief Medical Officer (CMO)

    Position Purpose:

    As a member of the Clinical Development team, work on the design, execution, data analysis and interpretation and reporting of clinical trials.  Act as Study Responsible Physician for one or more studies, and may be responsible for the clinical strategy for a development program.  Develop and review clinical study protocols.  Lead clinical study teams in collaboration with Clinical Operations.  Conduct medical review of patient data in all development phases of clinical studies.  Contribute to development of clinical operating guidelines for study sites and SOPs for internal use.  Present study results to management.

    Position Responsibilities:

    • Review and interpret and prepare medical sections of CSR’s in collaboration with medical writing to generate study report of clinical trial data, according to GCP.
    • Develop and deliver presentations and reports.
    • Review and interpret data for annual updates of safety reports, IBs, IND/NDA submissions and responses to questions from regulatory agencies.
    • Collaborate with pre-clinical, clinical operations, regulatory, drug safety, statistics and data management in the development of development strategies and clinical study protocols; review and provide input on other protocol related material (CRFs, DMP, SAP, etc.)
    • Lead study team meetings and provide medical guidance to the clinical operations team in the execution of clinical trials.
    • Secure, analyze and report on competitive intelligence related to successful conduct/execution of studies sponsored by other organizations and new data that may impact Syndax studies.
    • Present findings to senior development staff and clinical study management.
    • Partner with clinical operations team, as appropriate, to ensure study investigators and site staff are fully trained on protocol requirements

    Position Requirements:
    (Skills, Knowledge, Education and Work Experience)

    • MD degree with at least 3 years of experience in clinical research in a biotech/pharma organization required;
    • Oncology experience required—including clinical practice and clinical research;
    • Working knowledge of clinical trial management and medical review of oncology patient data;
    • Ability to communicate scientific and clinical information in documents and presentations;
    • Proven ability to effectively communicate with co-workers in a team-based environment;
    • Ability to work independently to achieve objectives and work on more than one project simultaneously.