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.
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.
- 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.
- 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.