Director, Clinical Research – REMS

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

📋 Description

• Formulate and implement the strategic direction and organizational structure for the department.

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

• Oversee projects as necessary.

• Collaborate with Managers and Project Directors to ensure appropriate staffing for projects; assess workloads and make adjustments as required.

• Participate in Business Development initiatives, including RFP assessment and completion, as well as bid defense preparation and execution.

• Showcase UBC's capabilities to prospective clients during bid defenses.

• Contribute to proposal development and budget evaluations.

• Ensure that project deliverables align with contract stipulations and meet the company’s quality standards, including precise reporting and metric interpretation.

• Guarantee that project team members receive sufficient training for their specific roles.

• Design and execute departmental structures and strategies based on staffing and project requirements.

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

• Organize and plan project activities, ensuring consistency in task execution.

• Address operational challenges in collaboration with Managers and project teams.

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

• Conduct performance evaluations for assigned direct reports.

• Facilitate staff interviews and assist in reviewing CVs of candidates.

• Maintain an up-to-date understanding of ongoing projects and timelines.

• Participate in team teleconferences, meetings, project evaluations, client consultations, and finance discussions.

• Provide updates on departmental activities to senior management.

• Lead cross-functional projects and manage all associated support functions.

• Supervise project revenue and invoicing, and maintain insight into project financial health.

• Cultivate and expand client relationships alongside UBC leadership and Business Development.

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

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

• Guide Managers during client and regulatory audits.

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

• Oversee multiple Managers and projects, including manager development, bid defenses, proposals, action plans, and alignment with client needs.

• Inspire project team members and promote collaboration.

• Plan and anticipate potential issues, outcomes, and changes to ensure success in programs and developments.

• Identify and optimize resource allocation.

• Perform additional duties as assigned by management.

⛳️ Requirements

• Advanced degree is preferred.

• Bachelor’s degree or equivalent experience is required.

• Extensive experience in project management within a CRO, or proven leadership and management experience overseeing multiple projects and teams.

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

• Proficient knowledge of the functional elements of clinical drug development (e.g., clinical, data management, statistics, and regulatory/medical writing).

• Exceptional project management abilities, with the capacity to lead through transitions and manage multiple large projects independently.

• Strong analytical and problem-solving skills, along with a willingness to identify process gaps, challenge assumptions, and drive improvements.

• Capability to work collaboratively under high-pressure situations.

• Excellent interpersonal, written, and verbal communication skills.

• Proven ability to interpret and prioritize customer requirements.

• Strong influencing and negotiation abilities.

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

• Ability to establish strong business relationships across diverse departments.

• Broad therapeutic experience is advantageous.

• Willingness to travel 10% as required.

• Extensive knowledge of Clinical Trial Monitoring is necessary.

• Clinical background or equivalent clinical research experience is required.

• Proven understanding of medical terminology.

• Experience in European/Global settings is a plus.

• Advanced computer skills are essential.

🏝️ Benefits

• Remote work opportunities.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching.

• Tuition reimbursement available after 90 days of employment.

• Flexible work environment.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Medical, dental, and vision insurance coverage.

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

• Access to telemedicine services (virtual doctor appointments).

• Wellness program.

• Adoption assistance.

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

• Long-term disability coverage.

• Life insurance benefits.

• Various discount programs.