Sr. Director - Risk Management & REMS Strategy
United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 10+ years
- Required Skills
- Business DevelopmentRisk Management
Requirements
- 10+ years of experience in pharmaceuticals, biotechnology, clinical research, or related healthcare/scientific consulting environments.
- Strong expertise in risk management, REMS programs, safety services, epidemiology, or clinical study design and operations.
- Proven leadership experience managing multidisciplinary teams, including project managers and operational staff.
- Deep understanding of FDA-regulated programs and pharmaceutical safety requirements.
- Experience supporting or leading protocol development, study design, registries, or real-world evidence initiatives.
- Strong business development and client-facing experience, including proposals, presentations, and bid defenses.
- Excellent communication, presentation, and stakeholder management skills across scientific and executive audiences.
- Strong organizational, financial oversight, and project governance capabilities.
- Bachelor’s degree in biological sciences or related field required; advanced degree in a health-related discipline preferred.
- Highly professional, detail-oriented, and able to manage multiple priorities in a fast-paced, client-driven environment.
- Ability to inspire teams, drive collaboration, and operate as a strategic leader across functions.
Responsibilities
- Lead and oversee risk management and REMS consulting services, acting as a primary point of contact for clients, partners, and internal teams across complex engagements.
- Drive operational and financial performance of safety and risk management programs, ensuring quality, efficiency, and profitability across projects.
- Support business development efforts, including proposal development, bid defenses, client presentations, and alignment of solutions with client needs and organizational capabilities.
- Contribute to strategic planning, annual business goals, and expansion of safety and risk management service offerings in collaboration with leadership teams.
- Oversee staffing, resource allocation, and project execution to ensure timely, high-quality deliverables across multiple concurrent programs.
- Guide the development and implementation of REMS strategies, epidemiologic studies, registries, and risk mitigation programs.
- Establish and improve SOPs, governance frameworks, and operational standards to support consistent service delivery.
- Engage in client meetings, conferences, and industry forums to promote expertise and strengthen partnerships.
- Track contracts, financial performance, and utilization to optimize project delivery and business outcomes.
- Provide leadership, supervision, and mentorship to project managers and functional team members, including performance management and team development.
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