Director, Clinical Research – REMS

🔥 4 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

📋 Description

• Develop and drive departmental strategy and structure • Mentor, provide support, and oversee Associate Project Managers and/or Project Managers • Manage projects as needed • Work with Managers and Project Directors to ensure projects are adequately staffed, monitor workloads, and adjust as needed • Assist with Business Development opportunities, RFP review and completion, and bid defense preparation and delivery • Present UBC capabilities to potential clients at bid defenses • Provide input into proposals and review budgets • Ensure performance of project deliverables according to contract terms and company quality expectations • Ensure accurate reporting and interpretation of metrics • Ensure project team members receive adequate training • Develop and implement department structure and strategies based on staffing and project needs • Ensure adherence to project plans, company policies, and sponsor SOPs • Plan and organize project activities with staff • Resolve operational issues with Managers and project teams • Report departmental, personnel, and site issues to Senior Management as needed • Conduct performance appraisals and staff interviews; assist with CV candidate review • Maintain working knowledge of active projects and timelines • Attend team teleconferences, project reviews, client meetings, and finance meetings • Provide departmental updates to senior management • Lead cross-functional projects and supervise supporting functions • Oversee project revenue and invoicing and monitor project financial health • Develop and grow client relationships and business with UBC leadership and Business Development • Mentor Project Managers and teams and facilitate Senior Management involvement for problem resolution • Identify improvement areas, provide solutions, and execute action plans • Lead Managers in client and regulatory audits • Assist with protocol development and patient/subject consent forms or REMS supporting documents • Directly supervise multiple Managers, projects, and assigned direct reports • Motivate project team members and foster teamwork • Plan and forecast 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 proven leadership/management experience managing multiple projects and project teams • Strong knowledge of FDA/ICH regulatory guidelines; only applicable for Europe if required • Working knowledge of 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 lead multiple large projects simultaneously • Solid problem-solving and analytical skills with willingness and ability to detect process gaps, challenge assumptions, and drive change and improvement • Ability 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 skills • Takes initiative and is results and detail oriented • Ability to build strong business relationships across various departments • Broad therapeutic experience a plus • 10% travel as required • Extensive knowledge of Clinical Trial Monitoring, as required • Clinical background or equivalency in clinical research experience, as required • Proven knowledge of medical terminology • European/Global experience a plus • Advanced computer skills

🏖️ Benefits

• Remote opportunities • Competitive salaries • Growth opportunities for promotion • 401K with company match • Tuition reimbursement (after 90 days of employment) • Flexible work environment • Discretionary PTO (Paid Time Off) • Paid Holidays • Employee assistance programs • Medical, Dental, and vision coverage • HSA/FSA • Telemedicine (Virtual doctor appointments) • Wellness program • Adoption assistance • Short-term disability (after 90 days of employment) • Long-term disability • Life insurance • Discount programs

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