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.

 

  • 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.
  • Senior Clinical Trial Manager

    Position Reports to:

    Vice President, Clinical Operations

    Position Purpose

    As a major contributor to the successful execution of clinical trials, perform a key role in building and maintaining relationships with Investigators and other study site personnel, CRAs and CRO team members.  Based on a thorough understanding of the mechanics of conducting clinical trials, closely supervise all aspects of Clinical Trial Operations, including clinical project management, oversight of study center activities, CRA monitoring activities and vendor management.

    Position Responsibilities

    • Directly oversee contract CRAs, CRO study team(s), clinical sites and vendor(s) on assigned studies to ensure consistency of methods, interpretation and approach with other Syndax sponsored studies;
    • Develop information/consent forms, study training materials, case report forms and study tools for assigned study;
    • Conduct training for logistics of the clinical trial including protocol contents and coordinating trial materials;
    • Oversee monitoring activities and conduct clinical site initiation visits, co-monitoring and close-out visits, as needed;
    • Manage study timeline and provide study progress reports to management;
    • Plan ahead and provide solution options for handling problems that develop;
    • Oversee to ensure that paper and electronic filing systems are maintained appropriately and in a timely manner;
    • Maintain tracking for study metrics essential to managing the study closely (patient visit information, data entry, monitoring and data cleaning information, etc.);
    • Ensure that all tasks that contribute to the conduct of a clinical study are completed according to GCPc and SOPs, as well as on time and within budget;
    • Assist in the development and review of protocols, investigator brochures, clinical study reports and other clinical documents and regulatory filings as needed.

    Position Requirements

    (Skills, Knowledge, Education and Work Experience)

    • Bachelors’ Degree in life sciences or healthcare discipline; Master’s Degree preferred.
    • At least 5 years of clinical trial management experience and at least 2 years of clinical monitoring experience, in the biotech/pharmaceutical industry; experience in supervising people;
    • Oncology trials experience is required;
    • Working knowledge of GCPc and FDA and ICH regulations and guidelines;
    • Experience with international clinical trials and managing external service providers, CROs and contract CRAs;
    • Good understanding of cross functional areas including data management / biostatistics, regulatory affairs and pharmacovigilance;
    • Proven verbal and written communication skills; enjoys interacting with others regularly;
    • Able to prioritize tasks and work independently;
    • Able to travel an average of 20%, both domestically and internationally.
  • Senior Drug Safety Specialist

    Position Reports To:

    Senior Director, Drug Safety & Pharmacovigilance

    Position Purpose

    Perform tasks related to serious adverse event (SAE) processing for assigned investigational product.  Work in close collaboration on safety issues with the Senior Director of Drug Safety and colleagues from Regulatory Affairs, Medical Affairs, Data Management, and Clinical Operations.  Serve as a liaison to external contract safety providers and CROs.

    Position Responsibilities

    • Conduct the review of all domestic and foreign SAE reports for all Syndax investigational products to make sure all important SAE elements are provided.
    • Ensure consistency in initial investigator causality assessment of SAE reports and source documentation for completeness, accuracy and legibility.
    • Draft case narrative for SAE reports and prepare MedWatch, CIOMS, and other forms, as needed.
    • Perform quality reviews of completed SAE reports received from contract drug safety vendors (CROs); transmit reports to Syndax business partners per timelines in safety data exchange agreements.
    • Exercise judgment and apply knowledge of FDA and ICH guidelines and product labeling in performing SAE case assessments of expectedness.
    • Generate appropriate queries to sites and/or contract drug safety vendors (CROs) to complete and clarify SAE case information; work with the CRO to determine when cases are complete and ready to close.
    • Collaborate with Regulatory personnel to communicate reporting of SAEs requiring expedited submission to Regulatory Authorities and to ensure appropriate reporting is performed per timelines.
    • Collaborate with cross-functional teams, Clinical Operations, Data Management and Biostatistics; participate in meetings and teleconferences with cross-functional teams, CROs, and business partners.
    • Deliver weekly or monthly metrics to supervisor efficiently, accurately and within agreed-upon timelines. Support supervisor with other SAE reporting and Pharmacovigilance Operations.
    • May assist in the preparation of safety sections for regulatory documents and in developing Safety forms, standard operating procedures and process guidelines.
    • May assist in signal detection activities and provide line listings for review.

     

    Position Requirements

    (Skills, Knowledge, Education and Work Experience)

    • Bachelor’s Degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field;
    • At least five years of progressive drug safety experience in a biotech/pharma company.
    • Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries.
    • Experience in SAE case-processing and working with safety databases.
    • Basic knowledge of MedDRA coding.
    • Proven knowledge of Good Documentation Practices and cGXPs.
    • Proficient in MS Office Suite.
    • Excellent written and verbal communication skills; fluent in medical terminology.
    • Ability to interpret and follow regulatory guidelines.
    • Ability to multi-task and balance day-to-day drug safety operations and project work with tight timelines.
    • Willing and able to work independently and in a collaborative team setting.