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.

 

  • Senior Director, Drug Safety & Pharmacovigilance

    Position Reports to: Chief Medical Officer

    Position Purpose:
    Provide leadership and medical oversight of global safety and pharmacovigilance activities for Syndax clinical trials, NCI trials and ISTs.

    Position Responsibilities:

    • Provide guidance for the development of Syndax pharmacovigilance strategies.
    • Establish and maintain policies and procedures to support Clinical Drug Safety objectives.
    • Perform the medical review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
    • Identify and evaluate safety signals through the assessment of single case safety reports and aggregate trend analyses.
    • Ensure ongoing evaluation of the overall safety profile of Syndax product. As product safety expert, collaborate with colleagues to bring potential safety issues to the attention of the Development Team and upper management.
    • Support Clinical Operations related to safety issues as required.
    • Provide input and review of responses to regulatory agency questions with regard to safety / pharmacovigilance activities.
    • Prepare and / or review safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB, and other documents, as needed.
    • Oversee the activities of both internal safety meetings (i.e. Pharmacovigilance Committee meetings) and external safety meetings with licensing partners (i.e. Joint Safety Management Team meetings).
    • Collaborate with pharmacovigilance and drug safety colleagues from licensing partners to align on a harmonized approach to identifying, evaluating and communicating safety issues.
    • Support development and maintenance of product benefit-risk profile.

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

    • M.D. degree and clinical experience, and at least 7 years of experience in Safety / Pharmacovigilance globally, including 2 – 3 years of experience in oncology required.
    • Working knowledge of FDA, EU, ICH guidelines and regulations governing Safety reporting and processing in clinical trial environments.
    • Working knowledge relevant to SAE analysis and SAE coding.
    • Proficient with Microsoft Windows: Word, Excel, Power Point.
    • Familiar with common Safety databases (e.g., Aris, AERS, Argus, etc.).
    • Excellent organizational, management, teamwork and interpersonal skills; prefers collaboration.
    • Able to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
    • Outstanding written and verbal communication skills.
    • Demonstrated skills in managing multiple projects.
  • Senior Manager, Clinical Data Management

    Status: Exempt
    Reports to: Senior Director, Clinical Data Management

    Position Description:

    The primary objective of this position is to coordinate and complete in-house data management activities to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting. Initially, this position leads one or more studies including performing data review/query management for those studies.
     

    Responsibilities and Duties:  

    • Oversee the establishment and maintenance of Data Management plans and study-specific data quality related documents;
    • CRF Development and EDC validation including edit specification development and validation;
    • Provide oversight of external partners (e.g. CDM CROs, central laboratories, ECG core labs, dictionary coding service providers, etc.) to ensure consistency and quality are maintained across projects;
    • Ensure that clinical data management activities for clinical trials and regulatory submission projects are completed on time and with excellent quality;
    • Ensure the delivery of clinical trial databases of the highest quality by establishing procedures for ongoing and final data review;
    • Ensure that CDM study files are organized and accessible during study conduct, and that archives are completed after study closeout;
    • Collaborate with cross-functional study team members in the conduct of clinical trials.

     

    Minimum Requirements:  

    • Bachelor’s degree in a scientific, medical or related field; Master’s degree preferred;
    • At least 7 years of experience in clinical data management, in pharmaceutical research environment, with progressively increasing staff and project supervision responsibility;
    • Thorough understanding of clinical trials process and regulatory requirements;
    • Thorough understanding of core CDM processes and procedures generally adopted as best practices within the industry, including knowledge of CDM processes with safety laboratory data management and dictionary coding for adverse events and medications;
    • Fully adept at the mechanics of conducting all phases of clinical trial data management within electronic data capture databases;
    • Familiar with the regulations that govern CDM activities;
    • Excellent organizational skills and able to adapt to multiple priorities in a fluid environment;
    • Excellent verbal and written communication skills;
    • Excellent skills in validating EDC databases and performing data review;
    • Experience with Merge eClinical highly desirable;
    • Experience in Oncology highly desirable;
    • Demonstrated leadership ability and project management skills;
    • Experience managing CROs in data management-related activities;
    • Ability to use PC and widely used software packages, e.g., Excel, MS Word, SAS programming highly desirable.