Join Our Crew

Responsibilities Include

Project Coordination and Management:

• Support the Clinical, Medical and Regulatory groups with extensive partnership with Clinical Operations, Clinical Development, Regulatory, and other team members, to develop and maintain project plans, timelines, and dashboards/trackers for multiple clinical programs in line with program, department, and corporate objectives.
• Manage the Clinical Project Team (CPT) working with VP, Clinical Development and VP, Clinical Operations
• Work extensively partnered with the lead Asset PM to support our cross-functional Product Development Team Program (PDT) and the CABA-201 clinical program.
• Work with Regulatory Affairs and Medical Writing to integrate submission planning and writing activities with team objectives
• Schedule and lead team meetings including developing agendas, publishing meeting minutes and decision logs, and tracking action items to completion.
• Extensively support ongoing program management initiatives and PMO best practices by utilization and/or creation of project management tools and templates across the company
• Initiate and maintain cross-functional collaboration and communication, as needed, to drive project progress and team alignment.
• Support the generation of tools to support an overall company project portfolio and contribute to the PMO culture of continuous improvement
• Identify, define, score, and communicate risks for each project/program as part of an overall risk register with risk mitigation and contingency plans, as required by Enterprise Risk Management (ERM) process
• Work across time zones as necessary.
• Travel (U.S.) 10-15% may be required.
• Other duties as assigned. 

Vendor Management:

• Working cross-functionally, coordinate with vendors and external partners to track, manage, and escalate, as needed, ongoing and upcoming projects with a focus on on-time delivery.
• Ensure project deliverables are met with required quality and timeline attributes.
• Track vendor performance, manage contracts, and address issues as they arise while nurturing short-term and long-term positive relationships.
• Facilitate communication between vendors and internal cross-functional teams including management of overall governance meetings with key vendors. 

SmartSheet Management:

• Utilize SmartSheet for project planning, tracking, and reporting both within a singular project and across multiple projects/programs creating one unified portfolio summary/report
• Create, maintain, and publish SmartSheet dashboards and reports for project status updates.
• Work with the PMO team to ensure that all department timelines and risk trackers integrate within the overall corporate portfolio and integrated roadmaps.
• As SmartSheet Super User, train and support team members on SmartSheet use, management, and reporting as well as other functionalities, as needed.

Required Qualifications

Qualifications:

• Bachelor’s degree in Life Sciences, Advanced degree is a plus.
• 7+ years of experience in clinical trial/program management and project/program management experience, or a similar role.
• Proficiency in MS Office (MS Outlook, PowerPoint, Excel, and Word); familiarity with project management tools is required.
• Extensive experience in utilization of Smartsheet including creation, maintenance, and reporting of timelines, Gantt charts, dashboards, and reports.
• Excellent external facing representation and experience in managing vendor relationships and contracts.
• Excellent verbal and written communication skills.
• Outstanding attention to detail with the ability to manage multiple tasks and priorities.
• Ability to work both independently and collaboratively with cross-functional teams.
• Thrives in a dynamic, fast-paced, timeline-based environment.
• Strong customer service focus as part of a centralized PMO function.
• Knowledge of clinical research processes and regulations is required.
• Certification in project management (e.g., PMP, CAPM) is an advantage.
• Experience in pharmaceutical or biotechnology industries is required.
• Experience with both early- and late-stage clinical programs is an advantage.

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