Director of Project Management - US

Clinigen is a global specialty pharmaceutical and services company operating in a complex regulatory environment to deliver vital medicines securely and on time worldwide. The Director of Project Management (US) leads and enhances the US Project Management department through strategic planning, resource management, and standardized processes across US and EU sites. The role ensures projects meet budget, timeline, and customer satisfaction objectives for clinical study services.

• Maintain and enhance the US Project Management department through strategic planning and workload evaluation across sites and team members.
• Ensure objectives are achieved in accordance with established budgets and customer satisfaction targets.
• Standardize project management practices and procedures across US and EU locations to enable shifting work/resources and improving efficiencies.
• Manage resources to deliver customer commitments on time.
• Coordinate with Business Development on client contract creation specifications.
• Oversee Project Managers in designing and implementing clinical study structures (including packaging/labeling, dispensing, and distribution of clinical trial materials and ancillary supplies).
• Oversee creation, review, and approval of processing documents and schedules aligned to client needs and timelines.
• Ensure accurate billing and documentation of project planning hours and activities.
• Act as a liaison between clients and CSM; travel to client locations as needed.
• Partner with Operations to maintain and track outstanding requests.
• Work with US Team Leads to ensure consistency and identify improvement areas.
• Collaborate with EU Project Management Director/Team Leads and EU PM team to harmonize processes and address issues.
• Delegate work, provide instruction, train, and oversee direct reports.
• Partner with Quality Assurance to develop or revise SOPs, Work Instructions, and Processing Protocols.

• Bachelor's degree.

• 4+ years of previous management experience.

• 8+ years of experience related to cGMP principles and practices and Clinical Trial Management (or equivalent combination of education, training, and/or experience).

• Proactive, detail-oriented approach to managing and solving daily operational problems.

• Ability to lead, coach, and mentor employees and provide direction in resolving issues.

• Exceptional oral and written communication skills, with active listening.

• Excellent time management and ability to adapt quickly in a fast-paced, changing environment.

• Self-motivated learner with initiative and strong problem-solving.

• Ability to maintain confidentiality of clients' proprietary and pharmaceutical-related information.

• Hybrid role: 3 days onsite and 2 days remote.

• Travel to client locations as needed.

• Benefits: competitive benefit offering; inclusive culture; weekly anonymous feedback channel with leadership; Equal Opportunity Employer.