[Hiring] Director, Clinical Research @UBC

Role 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, as directed, with 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 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.
• 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 updates 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 plans 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.

Qualifications

• 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.