Director, Clinical Research – REMS

🔥 7 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 10%

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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 • Work with Business Development to ensure presentation of a qualified team for bid defense and proposals • Provide input into proposals and review budgets • Ensure performance of project deliverables according to contract terms and company quality expectations, including accurate reporting and interpretation of metrics • Ensure project team members receive adequate training for specific job assignments • Develop and implement department structure and strategies based on current staffing and project needs • Ensure adherence to project plans, company policies and/or sponsor’s SOPs • Plan and organize project activities with staff as needed • Ensure teams consistently complete job-related tasks • Work with Managers and project teams to resolve operational issues • Report departmental, personnel, and/or site issues to Senior Management as needed • Conduct performance appraisals if assigned direct reports • Conduct staff interviews and assist with CV candidate review • Maintain working knowledge of all active projects and timelines • Attend applicable team teleconferences, meetings, project reviews, face-to-face client meetings, and finance meetings • Provide support and follow up on finance matters through resolution • Provide departmental updates to senior management • Lead projects with cross-functional involvement and supervise all supporting project areas • Oversee project revenue and invoicing, with strong understanding of project financial health • Work with UBC leadership and Business Development to develop and grow client relationships and business • Serve as a resource and mentor to Project Managers and teams for problem resolution • Identify improvement areas, provide solutions, and execute action plans • Lead Managers in client/regulatory audits as required • Assist in protocol development and/or patient/subject consent forms or REMS and REMS Supporting Documents as required • Supervise multiple Managers, projects, and direct reports as assigned • Develop Managers in presentations and bid defenses, proposals, and action plans • Ensure Managers understand client needs after project award • Assist Managers in anticipating and resolving project issues • Motivate project team members and foster teamwork • Plan and forecast potential issues, outcomes, and necessary changes • Identify and optimize resources • Perform other duties assigned by management

🎯 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 (additional or other relevant management experience may be considered) • 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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