Director, Clinical Research – REMS

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement departmental strategies and organizational structure.

• Mentor, support, and supervise Associate Project Managers and/or Project Managers.

• Manage projects as necessary.

• Collaborate with Managers and Project Directors to ensure proper staffing, monitor workloads, and make adjustments as needed.

• Assist with Business Development initiatives, including RFP review and completion, and preparation and delivery of bid defenses.

• Present UBC capabilities to prospective clients during bid defenses.

• Contribute to proposals and review budgets.

• Ensure project deliverables meet contract specifications and company quality standards.

• Guarantee accurate reporting and interpretation of metrics.

• Ensure project team members receive sufficient training.

• Develop and implement departmental structures and strategies based on staffing and project requirements.

• Ensure compliance with project plans, company policies, and sponsor SOPs.

• Organize and plan project activities with staff.

• Address operational challenges with Managers and project teams.

• Report departmental, personnel, and site-related issues to Senior Management as necessary.

• Conduct performance evaluations and staff interviews; assist with reviewing CV candidates.

• Maintain a comprehensive understanding of active projects and timelines.

• Participate in team teleconferences, project reviews, client meetings, and finance meetings.

• Provide departmental updates to senior management.

• Lead cross-functional projects and oversee supporting functions.

• Manage project revenue and invoicing while monitoring project financial health.

• Cultivate and expand client relationships and business with UBC leadership and Business Development.

• Mentor Project Managers and teams, facilitating Senior Management involvement for issue resolution.

• Identify areas for improvement, propose solutions, and implement action plans.

• Lead Managers in client and regulatory audits.

• Assist with protocol development and patient/subject consent forms or REMS supporting documentation.

• Directly supervise multiple Managers, projects, and assigned direct reports.

• Inspire project team members and promote teamwork.

• Anticipate and plan for potential issues, outcomes, and necessary adjustments.

• Identify and optimize project resources.

⛳️ Requirements

• Advanced Degree preferred.

• Bachelor’s degree or equivalent experience required.

• Extensive project management experience at a CRO or demonstrated leadership/management experience overseeing multiple projects and project teams.

• Strong understanding of FDA/ICH regulatory guidelines; applicable for Europe only if required.

• Familiarity with essential components of clinical drug development (e.g., clinical, data management, statistics, and regulatory/medical writing).

• Mastery of project management skills with the ability to lead through change and independently manage multiple large projects simultaneously.

• Strong problem-solving and analytical skills with a proactive approach to identifying process gaps, challenging assumptions, and facilitating change and improvement.

• Ability to thrive in a team environment under high-pressure situations.

• Excellent interpersonal, written, and verbal communication skills.

• Proven capability to interpret and prioritize customer needs.

• Strong influencing and negotiation abilities.

• Proactive, results-oriented, and detail-focused.

• Ability to build robust business relationships across various departments.

• Broad therapeutic experience is a plus.

• Willingness to travel up to 10% as required.

• In-depth knowledge of Clinical Trial Monitoring, as needed.

• Clinical background or equivalent experience in clinical research is required.

• Proven familiarity with medical terminology.

• European/Global experience is advantageous.

• Advanced computer proficiency.

🏝️ Benefits

• Remote work opportunities.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching.

• Tuition reimbursement (after 90 days of employment).

• Flexible work environment.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Comprehensive medical, dental, and vision coverage.

• Health Savings Account (HSA)/Flexible Spending Account (FSA).

• Telemedicine services (Virtual doctor appointments).

• Wellness programs.

• Adoption assistance.

• Short-term disability benefits (after 90 days of employment).

• Long-term disability coverage.

• Life insurance options.

• Employee discount programs.