Career Opportunities in Immunotherapy

Position Description:

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 leads one or more studies including performing data review/query management for those studies.

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.

 
Requirements:

• BS in a scientific or medical discipline; MS preferred and 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 IBM Clinical Development is 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 desirable

Position Description:

Syndax is seeking a strategic minded physician leader for the role of Vice President of Clinical Research & Development. The role will report to Chief Medical Officer. This is an exciting time as we push forward with P3 development activities for our lead program and expansion of our early development pipeline.

Overview:

The VP, Clinical Research and Development, will provide leadership for the clinical team and the drug development programs. The successful candidate will provide medical and scientific expertise on the strategy, design, execution and interpretation of data from clinical stage programs relating to the treatment of hematologic malignancies and solid tumors. This leadership role will be responsible for the clinical development function; direct reports include one or more physicians and other Clinical Development functions, depending on the background of the candidate.

He/she is responsible for 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. Duties include primary interactions with investigators and global monitors, functioning as the medical representative on the integrated project team, and providing medical consultations as needed across the Syndax portfolio of products and studies.

The individual will take on leadership of all early oncology clinical development programs and partner with CMO on late development activities for entinostat for the breast cancer indication and line extension programs. As a member of the Development Leadership team, he/she will work on the design, execution, data analysis and interpretation and reporting of clinical trials. The individual will interact closely with company management. A genuine interest and understanding of the science, desire to work in a highly collaborative organization, and deep passion about making a difference in the lives of patients are essential.

Responsibilities:

• Directly responsible for the clinical development strategy, including the clinical development plans and operational plans, for hematologic malignancies.
• Design and manage writing of oncology clinical study protocols from first-in-human phase 1 through phase 2 and phase 3 pivotal studies to support regulatory approvals.
• Present findings internally and externally (such as investigator meetings, regulatory agency meetings) acting as a spokesperson for Syndax relating to the trial/indication.
• Review and interpret and prepare medical sections of CSR’s and other regulatory documents in collaboration with medical writing to generate study report of clinical trial data, according to GCP.
• 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, translational medicine, regulatory, drug safety, statistics and data management in the development of development strategies and clinical studies; 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.
• Provide mentorship and development opportunities to others within Syndax Pharmaceuticals
• Responsible for resourcing clinical development programs within functional area.
• Ensures the highest level of ethical standards are following, in compliance with internal SOPs, regulatory agencies, and laws.

 
Qualifications:

• An MD degree with Board Certification or Board Eligibility in adult or pediatric oncology or hematology
• 8+ years of drug development industry experience in hematology/oncology programs, including a thorough understanding of drug development from IND to NDA.
• Strong leadership experience managing direct reports and influencing in a matrix environment.
• Candidates must possess effective written and oral communication and influencing skills.
• 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 to achieve objectives and work on more than one project simultaneously.