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, Clinical Operations

    Position Reports to:

    Vice President, Clinical Operations

    Position Purpose

    As the overall clinical trial manager, build and maintain relationships with Clinical Coordinators, Investigators, CRAs and CRO team members.  Interact frequently with site staff and CRA management and communicate regularly with senior management.  Based on a thorough understanding of the mechanics of conducting clinical trials, closely supervise all study-related activities from study start-up through study close-out and clinical study report writing.

    Position Responsibilities

    • Directly oversee contract CRAs, the 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.
    • Manage the process to prepare all clinical documents; write elements of protocols, clinical study reports, informed consents, study training materials / presentations, and other clinical documents, as needed.
    • Conduct both operational and study content training for CRAs and CRO study teams (and study site staff, as needed); ensure all team members are appropriately trained throughout the course of the study.
    • Oversee monitoring activities and conduct clinical site initiation visits, co-monitoring and close-out, as needed; review site visit reports and critical correspondence.
    • Manage study timeline and provide study progress reports to the study team. Provide 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 cleaning information).
    • Ensure 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.

     

    Position Requirements

    (Skills, Knowledge, Education and Work Experience)

    • Bachelors’ Degree in life sciences or healthcare discipline; Master’s Degree preferred.
    • At least 7 years of clinical trial management experience, including at least 2 years of clinical monitoring in biotech/pharmaceutical industry; some Oncology trial experience is preferred;
    • Skilled in supervising people;
    • Working knowledge of GCPc and FDA and ICH regulations and guidelines;
    • Experience with international clinical trials and managing external service providers, including 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, solve problems and work with a high degree of independence;
    • Able to travel up to 10% as needed, both domestically and internationally.
  • Associate Director/ Senior Manager, Statistical Programming

    Job Title: 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
  • 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 Accountant

    Position Reports to:

    Accounting Manager

    Position Purpose

    Ensures the integrity accounting information by recording, verifying, consolidating, and entering transactions on a timely basis.

    Position Responsibilities

    • Process invoices related to Contract Summary and Study Site Trackers in accordance with company policy and procedures;
    • Produce semi-monthly payroll.
    • Maintain monthly study site trackers.
    • Maintain monthly contract summary for “invoiced as incurred” contracts.
    • Prepare monthly balance sheet reconciliations.
    • Prepare monthly consolidating trial balance and consolidated statement of changes in shareholders’ equity.
    • Support month-end and year-end close process.
    • Develop and document business processes and accounting policies to maintain and strengthen internal controls.

    Position Requirements

    (Skills, Knowledge, Education and Work Experience)

    • Bachelor’s degree in accounting. CPA a plus, but not required.
    • 5+ years of accounting, some public accounting experience preferred but not required.
    • Accuracy and attention to detail.
    • Prefers to contribute as both independent, self-starter and collaborative team member.
    • Excellent organizational skills; prefers and is able to adapt to multiple priorities in a fast-paced and fluid work environment.
    • Excellent verbal and written communication skills.
    • Ability to function well in a team oriented environment.
    • Excellent computer skills, including Microsoft Office Suite: Calendar, Word, Powerpoint, and Excel.
    • Demonstrated multi-tasking and project management skills.
  • 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 Director, Clinical Operations

    Position Reports to:

    Senior VP, Chief Medical Officer

    The VP, Product Development and Program Management is also a key, internal stakeholder.

    Position Purpose:

    Manage and lead the clinical operations organization to ensure clinical trial and project objectives and tasks are accomplished with expected quality and within budget and expected timelines.

    As a core member of Development Team, lead the Integrated Clinical Team, participate on the Program Team, and other business teams as assigned by the SVP, CMO.  This position is located in Waltham, MA.   Travel to the NYC office and other domestic and international travel is expected.

    Primary Position Responsibilities:

    • Lead and manage all clinical development operations to ensure highest quality and consistency of methods and interpretation.
      • Contribute to and coordinate clinical team strategy updates.
      • Through managers, ensure that all clinical trial activities, including study start-up, close-out and report-writing, are planned and accomplished consistent with protocols and GXP, SOPs and regulatory practices and support Corporate Objectives.
      • Hire and train staff to support current skill requirements and the expanding portfolio.
      • Oversee the process to prepare all clinical documents and presentations, as needed.
      • Oversee electronic and paper filing systems to ensure access and compliance.
      • Establish methods for design, harmonization, and implementation of protocols, data collection systems and final reports.
      • Monitor adherence to protocols and determine study completion.
    • Build and manage collaborative working relationships with product development and cross-functional program team members, CRO’s, Investigators, and key Study Site personnel.
    • Act as a liaison with alliance partners to ensure study plans and execution are aligned with business development strategies.
    • Act as clinical project management lead for the clinical operations team:
      • As requested by the SVP, CMO, effectively communicate clinical trials status (planned and ongoing) to a diverse audience internally and externally.
      • Ensure a system to manage study metrics, timelines and provide progress reports.
      • Collaborate with project teams and finance to prepare and monitor project budgets.
      • Communicate with external resources, partners and vendors, to ensure coordination of mutually planned project commitments and activities.
      • Facilitate issue identification and resolution, contingency planning and decision making.

    Position Requirements

    (Skills, Knowledge, education and Work Experience)

    • Bachelors’ degree in Life Sciences required.
    • At least 12 years of pharmaceutical industry experience, including clinical trials management. At least 5 years’ experience in project management, team leadership, and/or functional line management.  Early Drug Development experience is a plus.
    • Oncology clinical trial experience required.
    • Proficiency in Project Management practices and tools required, e., Microsoft Work, Excel, PowerPoint and Project. Project management certification preferred.
    • Highly skilled in managing people directly as well as in cross-functional working teams.
    • Ability to work with cross-functional teams in a small-company environment is required.
    • Excellent decision-maker, problem-solver, and able to resolve differences as required.
    • Proven knowledge of GCP and FDA and ICH regulations and guidelines.
    • Experience with international clinical trials and managing vendors and contractors.
    • Working knowledge of cross-functional development functions, including data management, biostatistics, regulatory affairs and drug safety.
    • Proven verbal and written communication skills and developing relationships with team members and key stakeholders across all functions and management levels.
    • Able to travel up to 10% as needed, both domestically and internationally.
  • 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.
  • 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.
  • Senior Manager, Clinical Data Management

    Position Reports to:

    Senior Director, Clinical Data Management

    Position Purpose

    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 supports EDC validation of databases developed in-house and data review/query management of studies to clean them for study data deliverables.

    Position Responsibilities

    • 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.

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

    • 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