Director, Clinical Research REMS - BioPharma
Remote · United States
Job Summary
Director, Clinical Research REMS at UBC leads cross-functional, multi-project programs in the clinical research and REMS space. Responsibilities include staffing projects, coordinating bid defenses and proposals, assisting with business development and RFPs, developing department structures, ensuring compliance with contract terms and SOPs, training teams, monitoring project performance and financial health, mentoring managers and staff, supporting client meetings and audits, and driving process improvements. Must bring extensive project management experience in a CRO-like environment, deep knowledge of FDA/ICH regulatory guidelines, and strong leadership, communication, and relationship-building skills. Travel up to 10% and experience with clinical trial monitoring and regulatory operations are highly valued; European/Global experience is a plus. Remote opportunities available.
Required Qualifications
- Advanced degree preferred
- Bachelor’s degree or equivalent experience required
- Extensive project management experience at a CRO or equivalent leadership/management experience
- Strong knowledge of FDA/ICH regulatory guidelines
- Working knowledge of clinical drug development (clinical, data management, statistics and regulatory/medical writing)
- Mastery of project management and ability to lead multiple large projects
- Excellent interpersonal, written, and verbal communication skills
- Proven ability to interpret and prioritize customer needs
- Strong influencing and negotiation skills
- Ability to build strong business relationships across departments
- Travel up to 10%
- Clinical background or equivalent in clinical research experience
- European/Global experience a plus
- Advanced computer skills
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