Director, Clinical Research – REMS, BioPharma

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

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

• Manage projects as needed • Work with Managers and Project Directors to ensure projects are adequately staffed; monitor workloads and adjust as needed. • Assist, as directed, specific project opportunities in Business Development, 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 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. • Work with staff (as needed) to plan and organize project activities. • Ensure teams have consistency with completion of job-related tasks. • Work closely with Managers and project teams to resolve operational issues. • Report and discuss departmental, personnel and/or site issues with Senior Management, as needed, for possible resolutions. • Conduct performance appraisals if assigned direct reports. • Conduct staff interviews; assist with CV candidate review. • Working knowledge of all active projects and timelines. • Attend applicable team teleconferences/meetings as well as project reviews. • Attend face to face client meetings and provide support, as needed. • Attend finance meetings and perform necessary follow-up to resolution. • Provide departmental update to senior management, as requested. • Lead projects with cross-functional involvement and supervise all areas that support the project. • Oversee all project revenue and invoicing with strong understanding of project financial health. • Work with UBC’s leadership and Business Development to develop and grow client relationships and business to maximum potential. • Proactively serve as a resource and mentor to Project Managers and teams for problem resolution; facilitate the involvement of Senior Management as necessary. • Proactively identify areas of improvement, provide solutions and execute plan of action to address. • Lead Managers in client/regulatory audits, as required. • Assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents, as required. • Other duties as 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