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%

Status: Exempt
Reports to: Vice President, Regulatory Affairs/QA

Position Description:
The Director or Senior 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 Vice President, Regulatory Affairs and QA and is located in Syndax offices in Waltham, MA. This position title will be determined by the candidate’s prior experience.

Responsibilities and Duties:

• Provides guidance to clinical teams and supports the clinical team’s achievement of inspection readiness at all times.
• Supports compliance and regulation questions including quality review of clinical documents.
• 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.

 
Minimum Requirements:

• BA/BS and a minimum of 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.
• Clinical Quality Assurance with minimum of 2 years in people management preferred.
• Demonstrated knowledge of GCP, Clinical compliance and Auditing within an FDA-regulated environment. Solid understanding of clinical development and robust experience on GCP.
• 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.