Join the Syndax Team

Syndax 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/ Senior Manager, Statistical Programming

    Department Name: Biostatistics and Data Management

    Position Summary:

    The Associate Director/Senior Manager, Statistical Programmer performs the statistical programming required for analysis of clinical trial data on projects of moderate to high complexity for in-house and out-sourced clinical trials, commercial requests, ad-hoc analyses, biomarker analyses, Health Economics Outcome Research (HEOR) analyses, and integrated analysis such as integrated summary of efficacy (ISE) and integrated summary of safety (ISS).

    Duties and Responsibilities:

    • Acts as an integral member of project team. Attends project team meetings, works with vendors, biostatisticians, data managers, and clinical trial managers, as appropriate
    • Leads Submission Working Group programming activities related to ISS, and ISE deliverables
    • Serve as a lead programmer in the production of all tables, listings, and figures, and Case Report Form (CRF) tabulations for medium to high-complexity clinical trial programs including ISS/ISE
    • Serve as a lead programmer to support regulatory requests, commercial requests, ad hoc analyses, biomarker analyses, HEOR analyses etc.
    • Evaluates and/or identify opportunities for standardization across projects and leads small to medium sized cross functional groups to operationalize clinical data standards
    • Reviews critical Standards Artifacts and Processes (such as Statistical Analysis Plans, Data Validation Plans, eCRFs, etc.) and provides constructive comments
    • Helps solve critical issues requiring SAS expertise
    • Troubleshoots and provides quality review of complex SAS programs
    • Communicates strategically with CROs regarding SAS technical expertise
    • Codes SAS utility macros; writes and implements test plans to support SAS macro development
    • Programs statistical analyses (i.e., tables, listings, figures, and inferential statistical output) using SAS supporting commercial requests, regulatory requests, ad-hoc analysis, integrated analysis such as ISS and ISE
    • Performs SAS programming using complex techniques as SAS macro language, advanced data manipulation techniques, and statistical procedures (e.g., PROC GLM, PROC FREQ, PROC REPORT)
    • Prepare technical or procedural presentations for departmental meetings
    • Follows good programming practices and adequately documents programs
    • Keeps informed of SAS programming techniques as applied to clinical trials by reading relevant journals and/or attending courses/programming meetings
    • Understands and follows FDA regulations which affect the reporting of clinical trial data
    • Develops data collection, analysis and reporting standards content and processes
    • Participates in cross functional task forces and initiatives representing Biostatistics and Data Management

     
    Qualifications:

    Experience

    • B.A. / B.S. with at least 10 years of relevant experience or an M.S. with 7+ years of experience

     
    Other

    • Good analytical skills
    • Ability to communicate technical concepts clearly and concisely to non-technical colleagues
    • Strong organizational skills, attention to detail, and the ability to learn technical and clinical aspects of a clinical trial
    • Successfully completed several large or complex projects
    • Detail oriented
    • Ability to handle multiple projects with aggressive timelines
    • Leader and team player
    • Ability to multitask and prioritize work
    • Excellent knowledge of SAS
    • Familiarity with coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
    • Knowledge of pharmaceutical standard initiatives such as CDISC, ADAM, SDTM, and CDASH
    • Knowledge of medical and statistical terminology
    • Capable of using Windows, Word, Excel
  • Associate Director, Pharmaceutical Development & Manufacturing

    Status: Exempt
    Reports to: VP, Pharmaceutical Development & Manufacturing

    Position Description:

    This position will participate in the development of drug substance & drug product for protein pharmaceutical candidates in the Syndax clinical pipeline. Job responsibilities will include all phases of development and manufacturing.

    Responsibilities and Duties:

    • Manage ongoing relationships with drug substance, drug product and clinical supply CMOs and CROs to ensure that expectations for product quality, cGMP compliance, costs, and schedule are clearly understood, well-documented, and consistently met
    • Monitor manufacturing of drug substance and drug product
    • Lead the transfer of processes and analytical methods
    • Lead / support vendor site audits / inspections
    • Author/edit/review CMC sections for regulatory submissions, SOPs, batch records and technical reports
    • Work collaboratively across departments and with vendors to ensure timely batch release of clinical trial materials
    • Other responsibilities as assigned

     
    Minimum Requirements:

    • Ph.D. in Biology, Biochemistry, Chemistry or a related discipline with 8+ years of relevant experience within the biopharmaceutical industry, or an MS/BS with 15+years of relevant experience within the biopharmaceutical industry.
    • In-depth knowledge of pharmaceutical cGMPs, regulatory standards and guidance documents for all phases of drug development
    • Experience with drug substance and drug product process development and manufacturing for protein pharmaceuticals
    • Experience with aseptic manufacturing processes
    • Experience with managing contract manufacturing organizations
    • Experience with CMC regulatory submissions
    • Excellent written, verbal, interpersonal, communication and organizational skills
    • Strong attention to detail
    • Ability to multi-task and manage complex projects
    • Demonstrated success in working in a fast-paced team environment is essential
    • Proficiency in Microsoft Excel, PowerPoint and Project software
  • Controller

    Position Reports to: Chief Financial Officer

    Position Purpose:
    Oversee the entire internal and external accounting function and overall day-to-day management of accounting and controls of this dynamic, high-growth company. Ensure the accounting department serves the accounting needs of strategic partners, investors, the overall company and the various operating groups within the organization. Also ensure that the monthly, quarterly and annual financial, regulatory and management reporting is completed on a timely basis and in accordance with GAAP. Position is located in offices in either Waltham, Massachusetts, or New York, NY.

    Position Responsibilities:

    • Oversee the operations of the accounting department, including optimizing the departmental organizational structure and processes to achieve department’s goals and objectives.
    • Manage the accounting team.
    • Serve as primary contact for and manage external audit, valuation and tax service providers.
    • Drive financial and administrative projects.
    • Create detailed financial forecasts and analysis.
      Implement and ensure adherence to accounting policies and procedures.
    • Identify and execute opportunities to increase efficiencies and improve processes.
      Perform SEC reporting, maintain internal controls for key reporting processes, and drive processes and controls towards SOX compliance.
    • Assist in leading policy, procedure and process development and improvements.
    • Oversee equity accounting and third-party equity administration.
    • Manage financial information systems monitoring and controls.
    • Develop, implement and evolve business processes (e.g., purchase to pay) to support organizational growth/complexity.
    • Assess, implement/install and maintain accounting systems and business tools.

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

    • Experience with SEC reporting required; Big Four public accounting experience preferred.
    • Bachelor’s degree and CPA required.
    • At least 8 years of relevant experience; biotech industry experience required.
    • Thorough technical accounting knowledge of issues, procedures and practices.
    • Highly analytical with proven ability to identify and resolve problems with sound and accurate judgment.
    • Initiative to take ownership of this key function; demonstrated hands-on execution skills.
    • Able to relate and communicate effectively with executive management as well as all other functions in the organization.
    • SEC financial reporting as well as clinical trials accounting experience required.
    • Excellent written and oral skills; proven skills and success in managing accounting staff.
    • Involvement with developmental stage companies, with particular exposure to clinical operations is preferred.
  • Director of Quality Assurance

    Reports to: Head of Quality Assurance
    Location: Waltham, MA

    Position Purpose:

    The Director of Quality Assurance provides quality and compliance oversight of the quality systems at Syndax and those of contract manufacturing, testing, research and/or laboratory organizations. This position reports to the Head of Quality Assurance and is located in Syndax offices in Waltham, MA.

    Responsibilities:

    • Ensure GxP work at Syndax is done in compliance with applicable regulations and guidelines.
    • Provide quality and compliance oversight of the quality systems at Syndax and those of contract manufacturing, testing, research and/or laboratory organizations including, but not limited to: product complaints, deviations, OOS investigations, document creation and control, site audits, change control, validation (e.g. process, cleaning, analytical method, etc.), stability, batch record review, and product disposition.
    • Participate in the review, evaluation and approval of contract manufacturing, testing, research and/or laboratory facilities.
    • Manage controlled documents and systems.
    • Review and approve GxP related documents as requested and appropriate.
    • Participate on project teams and sub-teams as needed and assigned.
    • Track progress versus timelines and goals.
    • Ensure documents and records are kept in compliance with regulations and SOPs.

      
    Requirements:

    BA/BS and a minimum of 5-7 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.

    Preferred Qualifications:

    • Working knowledge of cGMP’s (CFR/ICH) and applicable international regulations/guidelines.
    • Experience with implementing and maintaining pharmaceutical quality systems.
    • Experience writing and presenting clearly on quality topics.
    • Prefer experience in oversight of outside vendors and contractors.
    • Ability to work in a virtual manufacturing environment.
    • Personal flexibility and a desire to lead, learn and achieve in a collaborative environment.
    • Ability to travel for both domestic and international business.
  • Senior Director, CMC

    Position Reports to: Consulting Vice President, Chemistry, Manufacturing & Controls

    Position Purpose:

    Provide input to the development of the manufacturing strategy for small molecule manufacture in support of clinical and commercial development. Participate in the implementation of these strategies at contract manufacturing organizations conducting manufacturing activities for small molecule manufacture. Ensure practices are in conformance with current global regulatory and compliance standards and Syndax standards.

    Position Responsibilities:

    • Oversee planning, manufacture, testing, packaging, and labeling of product in support of clinical trials and commercial distribution.
    • Manage activities and timelines at vendors conducting manufacturing, analytical and packaging activities.
    • Monitor work performed by selected vendors, including reviews of protocols, reports, raw data, methods and master and executed production records to ensure consistency with project and regulatory requirements, scientific integrity, and technical work agreement.
    • As required, design and monitor studies performed by selected outsourced vendors. Perform data analysis and prepare or review final report(s) for all such studies to ensure scientific integrity and compliance with regulatory requirements.
    • Participate in the creation of contracts and agreements, such as Non-Disclosure Agreements, Master Service Agreements, Contracts for all CMC materials and services, and Contract-Specific Quality Agreements.
    • Draft or review CMC sections of regulatory dossiers, ensuring accuracy and consistency with regulatory guidance.
    • Participate in cross-functional teams to support the development and commercialization of Entinostat and other small molecules which may enter development.
    • Prepare reports for management and identify issues to address with the cross-functional team.
    • Provide expertise and scientific direction regarding the evaluation and selection of new product technologies, in association with cross-functional evaluations and requirements from research, clinical, commercial, and regulatory teams.
    • Collaborate with Quality Assurance in conducting vendor compliance audits and preparing audit reports.

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

    • Degree in a relevant scientific discipline; advanced degree is preferred and at least 10 years of experience in CMC function in pharma/biotech organizations; small molecule experience required.
    • Demonstrated technical experience in preparing CMC portions of regulatory documents and ensuring CMC compliance.
    • Must be able to effectively manage multiple activities and problem solve to achieve business needs.
    • Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.
    • Must be flexible in adapting to a changing work environment and offer solutions to program challenges.
    • Business travel, domestic and international, to various company offices, CMOs, and partners as required.
  • 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.