Sr. Medical Director, Drug Safety & Pharmacovigilance

Position Responsibilities:

• Lead and support development of pharmacovigilance strategies for products within Therapeutic area, to ensure compliance with corporate clinical development and commercial goals.
• Oversight and conducting of signal detection activities include monitoring, evaluation, interpretation, management and communication of safety information.
• Responsible for oversight and conduct of Product Safety Committee (PSC) meeting(s) to evaluate risk-benefit for the compounds with support from cross-functional teams. Escalate and present safety issues to the Executive Safety Committee.
• Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects.
• Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR))
• Oversight of aggregate reports and signal evaluation reports for assigned projects.
• Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics.
• Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight of outsourced Medical activities, as applicable.
• Oversee and collaborate with internal safety scientists within TA
• Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws.
• Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., DMCs, Vendor oversight meetings, etc.)
• Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization.
• Support process improvement and functional training at departmental & company level
• Ensure that the highest quality, ethical & professional values are demonstrated in all aspects of work.
• Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations

Candidate Requirements:

• MD or MBBS or MD-PhD or equivalent medical degree
• 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
• Strong understanding of pharmacovigilance regulations in the US and EU.
• Experience in supporting drug safety activities in registrational clinical studies
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• Demonstrated skills in scientific analysis and reasoning.
• Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.
• Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable
• Strong track record of delivering results through effective team and peer leadership in matrix
• Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.