Senior Medical Director, Drug Safety & Pharmacovigilance

Syndax Limited • New York, NY

309d • $335,000 - $370,000

About The Position

Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Senior Medical Director, Drug Safety & Pharmacovigilance will be responsible for the overall clinical risk management and safety surveillance of assigned investigational and marketed products. This role involves leading and driving safety input to clinical development of oncology assets, ensuring efficient evaluation of adverse event and safety information to meet global compliance and regulatory requirements, and implementing risk management initiatives.

Requirements

• MD, DO, or equivalent required.
• Minimum 3 years 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 of Pharmacovigilance and Risk Management including safety in clinical development and post-marketing safety.
• Knowledge of clinical development process.
• Knowledge of related disciplines, e.g., statistics, epidemiology relevant to assessing drug utilization and safety.
• Demonstrated desire to develop organizational leadership skills.
• Excellent communication, writing and analytic skills.
• Sound medical-scientific and clinical knowledge and judgement.

Nice To Haves

• Board Certification.

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.
• Chair the cross disciplinary Syndax Safety Review Team for leading benefit risk topics.
• Accountable for scientific strategy for safety related documents and 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.
• Develop RMPs, pharmacovigilance strategies and risk minimization activities as warranted.
• Prepare safety summaries and analyses of safety related data for regulatory documents and aggregate reports.
• Lead safety strategy for the development of assigned products.
• Lead 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.
• Lead safety labeling activities for assigned products/program.
• Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or IRB/EC queries.
• Lead development of safety risk language, risk management strategy, pre-filing safety activities.
• Perform medical safety review of DSUR, annual reports, and other periodic safety submissions.
• Represent DSPV at HA meetings and drive safety strategy preparation for various meetings.
• Identify data gaps and prioritize data acquisition.
• Act as liaison for assigned products with Syndax functions.
• Support manufacturing quality and co-author integrated health hazard assessments.
• Develop communications of safety data & interpretation to Syndax and external parties.
• Contribute to the further development of pharmacovigilance within Syndax.
• Lead strategic projects within PV.
• Provide updates of the assigned drug's safety profile to senior management.

Benefits

• Competitive total compensation and rewards package.
• Equity offering.
• Annual target bonuses.
• Outstanding benefits program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: No Education Listed