Director, Clinical Research – REMS, BioPharma

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

📋 Description

• Oversee projects as necessary.

• Collaborate with Managers and Project Directors to guarantee adequate project staffing; assess workloads and make adjustments as required.

• Support specific project opportunities in Business Development, including RFP review, completion, and preparation for bid defenses, as directed.

• Showcase UBC capabilities to prospective clients during bid defenses.

• Collaborate with Business Development to ensure the presentation of a qualified team for bid defenses and proposals.

• Contribute to proposals and review budget estimates.

• Ensure project deliverables meet contractual obligations and company quality standards, including precise reporting and interpretation of metrics.

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

• Establish and execute departmental structure and strategies based on current staffing and project requirements.

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

• Collaborate with staff (as necessary) to plan and organize project activities.

• Ensure teams maintain consistency in completing job-related tasks.

• Work closely with Managers and project teams to address operational challenges.

• Report and discuss departmental, personnel, and/or site issues with Senior Management as needed for potential resolutions.

• Conduct performance evaluations if assigned direct reports.

• Conduct staff interviews and assist with reviewing CVs of candidates.

• Maintain an understanding of all active projects and timelines.

• Participate in relevant team teleconferences/meetings as well as project reviews.

• Attend face-to-face client meetings and provide support as necessary.

• Attend finance meetings and follow up as needed to achieve resolution.

• Provide departmental updates to senior management upon request.

• Lead projects involving cross-functional participation and oversee all supporting areas.

• Manage all project revenue and invoicing while having a strong grasp of project financial health.

• Partner with UBC's leadership and Business Development to cultivate and expand client relationships and business potential.

• Actively serve as a resource and mentor to Project Managers and teams for problem-solving; engage Senior Management as necessary.

• Identify areas for improvement proactively, offer solutions, and implement action plans to address them.

• Guide Managers during client/regulatory audits as needed.

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

• Perform other duties as assigned by management.

• Directly supervise multiple Managers, including their development in presentations, bid defenses, proposal implementation, and ensuring they understand client needs once a project is awarded.

• Responsible for overseeing direct reports along with multiple Managers and projects, when applicable.

• Serve as a mentor and resource for Managers in their daily tasks.

• Proactively aid Managers in anticipating and resolving potential and actual project challenges.

• Encourage project team members through teamwork.

• Maintain a positive attitude.

• Ability to plan and forecast potential issues, outcomes, and necessary changes to ensure program and developmental success.

• Ability to identify and optimize resources, including knowing when to assign additional or different resources.

⛳️ Requirements

• Preferred advanced degree; bachelor’s degree or equivalent experience is required.

• Extensive experience in project management at a CRO or proven leadership/management background managing multiple projects and teams (other 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.

• Strong problem-solving and analytical skills with the ability to identify process gaps, challenge assumptions, and drive 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.

• Self-starter with a focus on results and attention to detail.

• Ability to build robust 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 is necessary.

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

• Proven understanding of medical terminology.

• Experience in Europe/Global settings is a plus.

• Advanced computer skills are essential.

🏝️ Benefits

• Opportunities for remote work.

• 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 observed.

• Employee assistance programs offered.

• Comprehensive medical, dental, and vision coverage.

• Health Savings Account/Flexible Spending Account options.

• Telemedicine services (virtual doctor appointments).

• Wellness program available.

• Adoption assistance provided.

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

• Long-term disability insurance.

• Life insurance options.

• Various discount programs available.