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.

Note to Recruiters – Thank you for your interest in Syndax and our recruitment opportunities. Recruiting and employment are managed through the Human Resources Department. Syndax requires that a signed agreement be in place prior to the presentation of any candidates. We ask that recruiters and agencies do not contact or solicit employees or managers in an attempt to present candidates. The company will not be obligated or responsible for any related fees to resumes that are unsolicited.

 

  • Clinical Scientist (Hematology/Oncology)

    The Clinical Scientist will have a key role in drug development at Syndax Pharmaceuticals. The successful candidate will be a member of the clinical development team, working closely with the clinical research and development leader, statistician, data management, clinical operations, drug safety, and regulatory affairs to support investigations that deliver the development strategies. The successful Clinical Scientist contributes to the trial development strategy assisting with protocol development and study design and clinical study execution. The position will report to the Executive Director, Clinical Research and Development.

    The Clinical Scientist is responsible for reviewing and interpreting patient and study data and ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.

    Responsibilities include:

    • Interface internally and externally as the clinical science lead in support of a given study or program.
    • Provide clinical oversight of the study execution in collaboration with all members of the clinical study team. Participates in site visits as needed.
    • Review and monitor emerging safety and efficacy clinical data and develop sound, strategic solutions to study and program issues and collaborates with the clinical team to ensure issue resolution.
    • Support the MD leader with the development of program documents, including the clinical sections of various regulatory documents such as clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
    • In collaboration with biostatistics, clinical pharmacology, clinical operations and data management, contributes to the development of the plan to execute on trial design.
    • Collaborate with the clinical development team on the review, analysis, and interpretation of individual patient data and study results, ensuring appropriate medical data review and accurate data reporting.
    • Works closely with the MD to ensure he/she is informed of pertinent study information, including but not limited to safety and efficacy data.
    • Prepare data for various presentations.
    • Develop presentations and communicate study data results to colleagues internally and to external audiences, including investigators at sponsor meetings or general audiences at scientific conferences.
    • Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
    • Work as part of a highly matrixed organization to support the operational effectiveness of study execution.

     
    Experience and skills required:

    • RN, NP, MS, PhD or PharmD, or equivalent with clinical research experience. Advanced degree candidates preferred.
    • Strong analytical scientific background with at least 5 years of industry clinical development experience in oncology required.
    • Experience working with an external CRO is desirable.
    • Candidates must possess effective communication and influencing skills.
    • Thorough understanding of the drug development process from pre-IND through registration and post-registration required
    • Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization).
    • Has a general understanding of project management tools.
    • Ability to seek and understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy.
    • Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols
    • Ability to interpret, analyze, and present clinical data in order to inform decision-making and set clinical strategy.
    • Critical traits for success include strategic and proactive thinking, strong scientific and analytical skills, decisiveness and the ability to perform as a respected team member and leader.
    • Ability to work independently and to organize priorities and deliverables.
    • Ability to work in an environment with high expectations for achievement.
    • Ability to travel ~25%
  • Senior Scientist/Associate Director, Translational Sciences

    Position Description:
    Reporting to the CSO, this individual will work closely with an experienced development team to drive biomarker discovery and implementation in the clinic. The role will require close collaboration with internal development colleagues and external research vendors.

    Priorities include biomarker discovery, pharmacodynamic assay development, and implementation of biomarker assessments across clinical programs. Additionally, the individual will be responsible for analysis and presentation of correlative studies and biomarker data from clinical sample testing along with oversight of sample management activities. This full-time position is an exciting opportunity to make a difference at the cutting edge of discovery and implementation in the clinic and be part of a dynamic team.

    Responsibilities and Duties:

    • Provide expertise and leadership on development and implementation of program specific assays within program timelines
    • Prioritize and coordinate assay development efforts across programs; build systems and resources for rapid sample analysis from different studies
    • Establishes collaborative relationships with academic labs to build, test, and analyze correlative data
    • Keep current with advances in bioanalytical methodologies; evaluate, assess risks, and recommend new technologies that will be useful in expanding and enhancing gene therapy applications in model systems.
    • Identify and collaborate with external CROs to support assay development, validation and testing of samples to meet timelines for nonclinical and clinical studies, provide clinical teams with validated assays for sample analysis
    • Review and finalize assay reports to ensure scientific validity and regulatory requirements, and author IND /MMA/BLA sections related to bioanalytical methods and sample analysis, sections; participate in scientific advice preparations and meetings
    • Responsible for oversight of the logistics of investigational product, clinical non-drug material supplies, and biological samples generated in the conduct of clinical studies. This may require hands-on operational activities and will require close collaboration with clinical operations. Potential for oversight of others’ work.
    • Assure that investigational product, clinical non-drug material supplies, and biological samples generated in the conduct of clinical studies are shipped, tracked and received in a timely manner from originator to receiver locations
    • Commit to help the team provide deliverables and meet aggressive timelines. Present progress of work to project and study teams, as well as management review meetings.

     

    Minimum Requirements:

    • PhD in biological sciences such as immunology, cell and molecular biology.
    • 7+ years of experience working in oncology drug development with at least 5 years in industry or in an academic translational science research setting
    • Thorough knowledge and direct experience in assay development, qualification and validation, with scientific depth to support interpretation of results
    • Experience developing assays intended use included drug PK/TK, PD, additional safety and efficacy biomarkers, immunogenicity (including but not limited to anti-drug antibodies).
    • Experience with most recent genomic / gene expression analysis techniques and bioinformatics tools
    • Demonstrated history of working innovatively and efficiently while managing multiple projects
    • Demonstrated success and desire to work with a diverse team in a fast-paced environment under challenging timelines
    • Must have excellent interpersonal, organizational, and communication skills as well as the ability to work effectively as part of a multidisciplinary team.
    • Must have close attention to detail and provide hands-on support for operational activities