Position Summary:
The Director/ Sr. Director, Clinical Research and Pharmacovigilance, collaborates with physicians, scientists, regulatory professionals, data management, biostatisticians, executive staff, and others to develop and execute phase 1-3 interventional clinical trials.
This position is also responsible for collaborative oversight of Pharmacovigilance activities, including active participation in real-time medical monitoring of studies comprising patient eligibility assessment, study design questions, and addressing urgent safety questions to ensure patient safety, full regulatory compliance, and timely flow of drug safety information to clinical teams and senior management.
Essential Areas of Responsibility: Provide leadership, project management, direction, and program oversight to plan and conduct high-quality clinical trial protocols according to the specified clinical protocol, Good Clinical Practices (GCP), and FDA regulations.Author/review clinical trial documents, including study synopses, protocols, amendments, safety monitoring plans, risk management plans, clinical sections of IND reports, process documents, meeting presentations, publications, and clinical sections of regulatory documents to support product approvals.Assist in preparing and conducting study trainings for investigators, study sites, and internal colleagues to share new scientific and clinical data and maintain enthusiasm and engagement to optimize clinical trial enrollment.Participate actively as the clinical team's medical reference, overseeing study implementation and study medical monitoring.Conduct regular review, analysis, and interpretation of study results.Participate in identification/analysis of any potential safety concerns and/or adverse events/serious adverse events across trials and ensure these are properly tracked and recorded.Provide scientific support and feedback to the clinical team regarding study conduct, adjustments in the study and/or strategy based on the data, and study safety/efficacy.Proactively monitor and report trial performance, progress, and timelines.Closely interface and coordinate with cross functional teams including clinical operations, data management, statistics, regulatory affairs, information technology (IT) and among other departments on clinical research activities.Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues and communicate developments to clinical staff, and other team members.Establish relationships with external experts, consultants, opinion leaders, regulators, and disease specific investigator networks.Participate in recruitment of new employees to ensure department is staffed with qualified personnel.Minimum Education, Experience and Skill Requirements: Education: Advanced degree with specialization or concentration in clinical/science (e.g., MD or foreign equivalent degree preferred; minimum PharmD, PhD, MPH, or foreign equivalent degree)Experience: 7+ years or more of industry related experience in clinical trials.Experience in immuno-oncology or oncology (preferred).Good knowledge of clinical research and experience across all clinical phases.Proven track record in clinical medicine and background in biomedical research is essential.Demonstrated record of scientific scholarship and achievement.Working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH guidelines).Ability to write reports for external presentations and publication in medical journals is essential.Managing patient data, including coordinating data acquisition from collaborating institutions.Strong interpersonal skills, with experience working effectively on cross-functional teams is critical.Familiarity with clinical trial design and experience authoring clinical trial protocols.Experience in the analysis and interpretation of clinical data and assessment of clinical relevance.Comprehensive understanding of safety profiles and risks.Ability to analyze and interpret complex datasets.
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