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.

 

  • Associate Director, Biostatistics

    Status: Exempt
    Reports to: Senior Director, Biostatistics

    Position Description:

    Play a leading role in designing efficient trials and conducting clinical, PK/PD, and biomarker data analyses, serve as a key member on clinical development planning teams, and provide statistical consultation to development team. This person will have strong technical expertise, be able to proactively contribute to the development of clinical and regulatory strategies, and may also manage junior biostatisticians.

    Responsibilities and Duties:

    • Play a leading role in designing efficient clinical trials
    • Provide major contributions to clinical development strategies
    • Serve as an influential statistical consultant to medical and development team
    • Independently conduct clinical trial simulations
    • Independently perform clinical, biomarker, and PK/PD data analyses
    • Interpret clinical trial results
    • Deliver statistical lectures on new statistical advancements
    • Write statistical analysis plans, statistical sections of protocols, and reports
    • Review relevant medical literature
    • Help develop protocols, case report forms, and clinical study reports
    • Provide leadership to clinical development teams when needed
    • Act as an integral member of project team, collaborate effectively with other team members, and attend project team meetings
    • Perform statistical programming for advanced statistical methodologies and help statistical programmers QC their programs
    • Conduct quality review of statistical analyses
    • Keep updated with regulatory requirements
    • Interact effectively with regulatory authorities
    • Mentor or manage junior biostatisticians

     
    Minimum Requirements:

    Experience:

    • M.S., Biostatistics or equivalent with at least 9 years of pharmaceutical, biotechnology, or equivalent experience, or Ph.D. in Biostatistics or equivalent with at least 6 years of pharmaceutical, biotechnology, or equivalent experience.

     
    Other:

    • Profound understanding of advanced clinical trial design and statistical analysis methodologies
    • Good understanding of the big picture of an overall development program
    • Capable of thinking strategically
    • Excellent communication and interpersonal skills
    • Ability to lead project teams, as well as work in a cross-functional team
    • Successfully completed several large or complex projects
    • Strong ability to quickly capture key information from medical journal articles
    • Understand regulatory requirements and good clinical practice guidelines
    • Ability to multitask and prioritize work
    • Good statistical programming skills using SAS and other statistical software
    • Good leadership and consultation skills
  • Medical Science Liaison

    Status: Exempt
    Reports to: Senior Director, Medical Affairs

    Position Description:

    Serving as a field-based extension of the Medical Affairs Department, the Medical Science Liaison (MSL) will represent Syndax and our novel, Breakthrough Therapy Designation oncology drug candidate in development as a combination therapy in multiple cancer indications, with an initial focus on tumors that have shown sensitivity to immunotherapy, such as HR+ breast cancer.

    The MSL will deliver clinical and scientific data, and technical/practical education, to thought leaders, payers and other stakeholders within the medical oncology community. The MSL is responsible for developing, coordinating and assuring implementation of the Company’s corporate, scientific, and clinical strategies to these thought leaders within academic, clinical, and healthcare organizations. The MSL will build long-term peer-to-peer relationships and establish rapport with these thought leaders through highly scientific product and disease-related discussions. These scientific exchanges will support and/or expand current combination immuno-therapy therapeutic concepts, as well as ensure the safe and effective utilization of Company product(s).

    Additionally, the MSL will supports research initiatives and investigator-sponsored studies and participate in and contribute to projects and initiatives that increase the value and productivity of the Medical Affairs team.

    Responsibilities and Duties:

    • Maximizes and leverages thought leader relationships by identifying mutually beneficial opportunities that meet the strategic needs of internal stakeholders
    • Supports medical strategies for Company compounds and responds to unsolicited requests for medical information from HCPs
    • Participates in and contributes to projects and initiatives that increase the value and productivity of Medical Affairs
    • Develop and maintain strong collaborative relationships with external experts vital to product development
    • Gather insights and input on treatments and gain understanding of the needs and treatment patterns of oncology health care providers to help shape company strategies
    • Enhance scientific knowledge of external stakeholders through education and appropriate scientific exchange
    • Serve as a liaison between clinical investigators and internal stakeholders in support of investigator-sponsored studies
    • Collaborate with R&D team to support sites and investigators participating in Company-sponsored clinical trials (e.g. identify accrual challenges, educate study staff)
    • Attend appropriate scientific meetings and remain current of new and emerging scientific information and treatment options in relevant therapeutic areas/tumor types
    • Collaborates across functions to ensure achievement of key goals
    • Presents scientific information to external customers, including at medical meetings or Company sponsored meetings (may also staff Medical Information booth)
    • Consistently provides assistance in identifying, evaluating, and screening qualified research sites for clinical investigation
    • Actively participates in and contributes to Medical Affairs or cross-functional projects/initiatives

     

    Minimum Requirements:

    • PharmD, PhD, MD, MSN/NP, MS/PA, or BSN/RN
    • Minimum of 3 years’ experience as an Oncology/Hematology MSL required
    • Strong interpersonal, organizational, team, written and verbal communication skills
    • Well-versed in highly technical and scientific languages in order to communicate with key Thought Leaders, Medical Affairs, Research and Development, as well as other key internal and external stakeholders
    • Firm understanding of the key phases, processes, and techniques that are involved in both the pre-clinical and clinical aspects of drug development
    • Proven track record of teamwork, leadership, timely decision making and results orientation in meeting objectives
    • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
    • Willingness to travel (up to 60%) within the territory
    • Valid driver’s license
  • 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.