Sr. Director - Risk Management & REMS Strategy

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Sr. Director - Risk Management & REMS Strategy in United States.

This senior leadership role sits at the intersection of pharmaceutical safety, regulatory strategy, and client advisory services, driving the design and execution of risk management and REMS (Risk Evaluation and Mitigation Strategies) consulting programs. You will oversee complex, cross-functional initiatives supporting drug development and commercialization, ensuring compliance, scientific rigor, and operational excellence. Acting as both a strategic advisor and business leader, you will guide clients, internal teams, and external partners through high-impact safety and risk management solutions. The role combines scientific expertise, commercial leadership, and operational oversight within a fast-paced, client-facing environment. You will also play a key role in shaping service offerings, supporting business growth, and representing capabilities in external forums. This is a highly influential position for a leader passionate about advancing patient safety and improving healthcare outcomes.

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Accountabilities:

• 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.

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.

Benefits:

• Competitive compensation package aligned with senior leadership responsibilities.
• Remote work flexibility.
• Comprehensive medical, dental, and vision insurance coverage.
• 401(k) with company match.
• Discretionary PTO and paid holidays.
• Tuition reimbursement and career development opportunities.
• Employee assistance and wellness programs.
• HSA/FSA options and telemedicine services.
• Life insurance, short-term and long-term disability coverage.
• Adoption support and employee discount programs.
• Inclusive, collaborative work culture focused on innovation and professional growth.

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How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

 Why Apply Through Jobgether? 

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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