Director, Clinical Research – REMS

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

📋 Description

• Formulate and implement departmental strategy and structure.

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

• Manage projects as necessary.

• Collaborate with Managers and Project Directors to ensure adequate project staffing, monitor workloads, and make adjustments as required.

• Assist with Business Development initiatives, including RFP evaluation and completion, as well as bid defense preparation and execution.

• Showcase UBC capabilities to prospective clients during bid defenses.

• Work with Business Development to present qualified teams for bid defenses and proposals.

• Contribute to proposals and review budgets.

• Ensure project deliverables align with contract terms and meet company quality standards, including accurate reporting and interpretation of metrics.

• Ensure that project team members receive sufficient training.

• Develop and execute departmental structure 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 alongside Managers and project teams.

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

• Conduct performance evaluations and staff interviews, and assist with CV candidate assessments.

• Maintain knowledge of active projects and their 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.

• Monitor project revenue, invoicing, and financial viability.

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

• Act as a resource and mentor for Project Managers and teams.

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

• Guide Managers during client and regulatory audits.

• Assist in the development of protocols and patient/subject consent forms or REMS and REMS Supporting Documents.

• Supervise multiple Managers and projects, including preparation for presentations and bid defenses.

• Inspire project team members and promote teamwork.

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

• 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 teams.

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

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

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

• Strong problem-solving and analytical abilities.

• Capability to work in a team environment under high-pressure situations.

• Excellent interpersonal, written, and verbal communication skills.

• Proven ability to interpret and prioritize customer needs.

• Strong influencing and negotiation capabilities.

• Initiative-driven, results-oriented, and detail-focused.

• Ability to forge strong business relationships across various departments.

• Broad therapeutic experience is a plus.

• Willingness to travel up to 10% as required.

• Extensive knowledge of Clinical Trial Monitoring, as necessary.

• Clinical background or equivalent experience in clinical research, as required.

• Proven understanding of medical terminology.

• European/Global experience is a plus.

• Advanced computer skills.

🏝️ 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.

• Medical, dental, and vision coverage.

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

• Telemedicine services (Virtual doctor appointments).

• Wellness initiatives.

• Adoption assistance.

• Short-term disability coverage after 90 days of employment.

• Long-term disability coverage.

• Life insurance.

• Various discount programs.