Director, Clinical Research - REMS

United Biosource Corporation•All Virtual Locations, Home Based Position, USA, Remote, US,

23h•Remote

About The Position

The Director, Clinical Research develops and drives departmental strategy and structure, mentors and supports Associate Project Managers and Project Managers, and oversees their work. The role may manage projects directly and leads projects with cross-functional involvement, supervising the areas that support each project. It ensures project deliverables meet contract terms and company quality expectations, including accurate reporting and interpretation of metrics, and that teams follow project plans, company policies, and sponsor SOPs. The Director works with Managers, Project Directors, Business Development, UBC leadership, project teams, and Senior Management on staffing, workloads, proposals, budgets, bid defenses, client relationships, operational issues, and departmental updates. The role oversees project revenue and invoicing, supports audits and regulatory/client meetings, and may assist with protocol development and REMS materials. It also provides managerial supervision, staff development, mentoring, performance appraisals, and resource planning as assigned.

Requirements

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; other relevant management experience may be considered.
Strong knowledge of FDA/ICH regulatory guidelines; European guidelines are applicable if required.
Working knowledge of clinical drug development functions, such as clinical operations, data management, statistics, and regulatory/medical writing.
Mastery of project management skills and ability to lead through change and independently lead multiple large projects simultaneously.
Strong problem-solving and analytical skills, including 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.
Initiative, results orientation, and attention to detail.
Ability to build strong business relationships across departments.
Extensive knowledge of clinical trial monitoring, as required.
Clinical background or equivalent clinical research experience, as required.
Proven knowledge of medical terminology.
Advanced computer skills.
Ability to travel up to 10% as required.

Nice To Haves

Advanced degree preferred.
Broad therapeutic experience.
European/global experience.

Responsibilities

Develop and drive departmental strategy and structure based on staffing and project needs.
Mentor, support, and oversee Associate Project Managers, Project Managers, Managers, and project teams.
Manage projects as needed and lead cross-functional projects, supervising all supporting areas.
Work with Managers and Project Directors to ensure adequate project staffing, monitor workloads, and adjust resources as needed.
Assist with Business Development opportunities, RFP review and completion, bid defense preparation and delivery, and proposals.
Present UBC capabilities to potential clients at bid defenses and work with Business Development to assemble qualified proposal and bid-defense teams.
Provide input into proposals and review budgets.
Ensure project deliverables meet contract terms and company quality expectations, including accurate reporting and interpretation of metrics.
Ensure project team members receive appropriate training for their assignments and adhere to project plans, company policies, and sponsor SOPs.
Work with staff to plan and organize project activities and ensure consistent completion of job-related tasks.
Work with Managers and project teams to resolve operational issues; escalate departmental, personnel, or site issues to Senior Management as needed.
Conduct performance appraisals for assigned direct reports; conduct staff interviews and assist with CV candidate review.
Maintain working knowledge of active projects and timelines; attend relevant team meetings, teleconferences, and project reviews.
Attend face-to-face client meetings and provide support as needed; attend finance meetings and follow up on outstanding matters.
Provide departmental updates to Senior Management as requested.
Oversee project revenue and invoicing and maintain a strong understanding of project financial health.
Work with UBC leadership and Business Development to develop and grow client relationships and business.
Serve proactively as a resource and mentor to Project Managers and teams, facilitate problem resolution, and involve Senior Management when necessary.
Identify improvement opportunities, develop solutions, and execute action plans.
Lead Managers in client and regulatory audits as required.
Assist with protocol development and, as required, patient/subject consent forms, REMS, or REMS Supporting Documents.
Supervise multiple Managers, including developing their presentation and bid-defense capabilities, proposing and implementing action plans, and ensuring understanding of client needs after project award.
Anticipate and help resolve potential and actual project issues; foster teamwork and motivate project team members.
Plan and forecast potential issues, outcomes, and changes needed for program and development success; identify and optimize resources.
Perform other duties as assigned by management.