Senior Medical Director, Pharmacovigilance Physician

Summary

Join Syndax Pharmaceuticals as a Contractor, Senior Medical Director, Pharmacovigilance Physician and play a pivotal role in ensuring the safety of our investigational and marketed oncology products. Lead and drive safety input into clinical development, overseeing safety data evaluation from various sources. You will chair the Syndax Safety Review Team, develop risk management plans, and prepare safety summaries for regulatory documents. Collaborate with cross-functional teams, regulatory agencies, and senior management. This role requires strong medical-scientific knowledge, excellent communication skills, and experience in pharmacovigilance and risk management. Syndax offers a competitive salary and a remote work option.

Requirements

• MD, DO, or equivalent
• Minimum 3 years of clinical practice experience preferred, following post-graduate medical training
• Experience in a pharma/biotech or regulatory agency required in a relevant function such as clinical safety, pharmacovigilance or risk management
• Thorough understanding (based on experience) of Pharmacovigilance and Risk Management including safety in clinical development and post-marketing safety
• Knowledge of clinical development process
• Knowledge of other related disciplines, e.g., statistics, epidemiology relevant to assessing drug utilization and safety at the population level
• Demonstrated a desire to develop organizational leadership skills
• Excellent communication, writing and analytic skills
• Sound medical-scientific and clinical knowledge and judgement

Responsibilities

• Work closely with cross-functional team members including those from clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet global pharmacovigilance and risk management strategies for assigned products
• Chair the cross disciplinary Syndax Safety Review Team for leading benefit risk topics
• Accountable for scientific strategy for safety related documents (e.g., CTD components, Risk Management Plans (RMP) and Periodic Safety Update Reports) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate
• Responsible for safety surveillance activities such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgement in review of aggregate data and individual cases
• Responsible for the development of RMPs, pharmacovigilance strategies and risk minimization activities as warranted
• Prepares safety summaries and analyses of safety related data for regulatory documents and aggregate reports and may supervise the activities of CSRM Staff in the execution of safety data analysis and authoring of regulatory documents
• Leading and driving safety strategy for the development of assigned products
• Leading all interactions regarding product safety issues with Research & Development governance committees and regulatory agencies
• Work closely with Leadership to implement the evolving direction for the risk management and safety function of the department, as well as helping to develop and align processes to support departmental objectives
• Lead safety labeling activities for assigned products/ program. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/ Provide input at cross-functional labeling team meetings and provide regional safety labeling support
• Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries
• Lead development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, safety-focused publication development
• Perform medical safety review of DSUR, annual reports, and other periodic safety submissions
• Represent DSPV at HA meetings. Actively drive safety strategy preparation for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc
• Identify data gaps and Prioritize data acquisition. Provide input to strategic plans for safety differentiation of Syndax products
• Act as liaison for assigned products with Syndax functions (Legal, BD, Operations, Marketing, etc.)
• Support manufacturing quality. Co-Author integrated health hazard assessments
• Develop communications of safety data & interpretation to Syndax and external parties, globally
• Contribute to the further development of pharmacovigilance within Syndax by staying informed and addressing changes in the regulatory environment and developments and trends in the discipline
• Lead strategic projects within PV
• Provide updates of the assigned drug’s safety profile to senior management and recommend pharmacovigilance / risk management activities
• Depending on the status of development of the compound, may be required to strategically lead, manage and medical-scientifically direct a team of risk management physicians responsible for an investigational compound

Preferred Qualifications

Board Certification

Benefits

• $275 - $330 per Hour
• #LI-Remote