Director, Clinical Research – REMS

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

📋 Description

• Develop and execute 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 appropriate staffing for projects; monitor workloads and make adjustments as required.

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

• Present UBC capabilities to prospective clients during bid defenses.

• Collaborate with Business Development to ensure a qualified team is presented for bid defenses and proposals.

• Contribute to proposals and review budgets.

• Ensure project deliverables are performed in accordance with contract terms and company quality standards, including precise reporting and interpretation of metrics.

• Ensure project team members receive adequate training for their specific job roles.

• Develop and execute departmental structure and strategies in alignment with current staffing and project requirements.

• Ensure compliance with project plans, company policies, and/or sponsor’s SOPs.

• Plan and organize project activities with staff as necessary.

• Ensure teams consistently complete job-related responsibilities.

• Collaborate with Managers and project teams to address operational challenges.

• Report departmental, personnel, and/or site-related issues to Senior Management as needed.

• Conduct performance evaluations if overseeing direct reports.

• Conduct staff interviews and assist in reviewing CV candidates.

• Maintain a working knowledge of all active projects and their timelines.

• Attend relevant team teleconferences, meetings, project reviews, in-person client meetings, and finance meetings.

• Provide support and follow up on financial matters until resolution.

• Deliver departmental updates to senior management.

• Lead projects with cross-functional involvement and oversee all supporting project areas.

• Manage project revenue and invoicing, with a strong understanding of the project's financial health.

• Collaborate with UBC leadership and Business Development to cultivate and expand client relationships and business.

• Serve as a resource and mentor to Project Managers and teams for problem-solving.

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

• Lead Managers through client and regulatory audits as necessary.

• Assist in protocol development and/or patient/subject consent forms or REMS and REMS Supporting Documents when required.

• Supervise multiple Managers, projects, and direct reports as assigned.

• Develop Managers in presentations, bid defenses, proposals, and action plans.

• Ensure Managers grasp client needs post-project award.

• Assist Managers in forecasting and addressing project issues.

• Encourage project team members and promote teamwork.

• Plan and anticipate potential issues, outcomes, and necessary adjustments.

• Identify and optimize resource allocation.

• Perform additional duties as assigned by management.

⛳️ 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 (additional relevant management experience may be considered).

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

• Working knowledge of the functional 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.

• Solid problem-solving and analytical abilities with the willingness to identify process gaps, challenge assumptions, and drive change and improvement.

• Ability to thrive 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.

• Proactive and detail-oriented with a results-driven mindset.

• Ability to build robust business relationships across various departments.

• Broad therapeutic experience is a plus.

• 10% travel as required.

• Extensive knowledge of Clinical Trial Monitoring, as required.

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

• Proven familiarity with medical terminology.

• European/Global experience is advantageous.

• Advanced computer skills.

🏝️ Benefits

• Remote work opportunities.

• Competitive salaries.

• 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)/Flexible Spending Account (FSA).

• Telemedicine (virtual doctor appointments).

• Wellness programs.

• Adoption assistance.

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

• Long-term disability.

• Life insurance.

• Discount programs.