Clinical Project/Program Manager (CPM) / Sr. CPM with VIVUS, Inc.

VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. Analysts speculate that the potential market for obesity ranges from $5 billion to $10 billion annually, the potential market for an effective diabetes therapy that causes weight loss is in excess of $2 billion, and the indications targeted by VIVUS' sexual health products each represent a projected market greater than $1 billion annually.

 

Summary: 

 

As part of Clinical Development and reporting to the VP or Sr. Director of Clinical Development, this person works with VIVUS team members and/ team leaders in planning, implementing, & executing clinical trials and programs in accordance with company SOPs, FDA, & ICH guidelines and regulations. This individual provides internal direction, leadership and accountability for Clinical Projects.

 

This individual works well with all levels of staff and outside contacts in a professional manner.  As appropriate, is able to easily delegate work, promote cooperation amongst the staff and resolve conflicts in a manner which encourages good work relations.

 

This individual will have a pivotal role in managing timelines and deliverables for key clinical milestones for the company. This individual can effectively apply project management related support to teams and team-leaders meet overall corporate objectives leading to submission for world-wide marketing applications.  In addition, this individual will oversee and execute operational delivery of clinical trials and may supervise staff associated with clinical operations activities.

 

Responsibilities:

 Leads the Clinical Operations effort for clinical projects Responsible for setting and managing overall project timelines and budgets.Designs, implements and assesses the effectiveness of standardized project management processes and procedures. This includes standardized project documentation and methodology and project tracking and reporting procedures.Ensure the development and or maintenance of a functional Project Management process.Is accountable for routine and Ad Hoc reports to the senior leadership team as to the status and, when necessary, corrective action necessary to meet project cost and timeliness objectives.Develops cross-functional, change management and implementation strategies related to project Management, ensuring that all of the participating parties have committed to effective implementation of the processes and procedures.Utilizes influencing prowess to overcome objections that hamper the implementation of critical project management process improvement efforts.Develops and implements key metrics to measure and report on progress of all initiatives.Responsible for selection and management of external vendors.

 

Requirements:

 B.S./M.S./PhD in Biology, Chemistry, Engineering or related Scientific discipline from an accredited college or university.  PMP certification required for Sr.CPM.  The person will ideally have three plus years of project management responsibilities which routinely required influencing and directing multi-division or multi-company entities.  Experience with and working knowledge of the drug development process essential (CMC, clinical, sales and marketing).  Experience managing and leading the successful implementation of multi-year, multi-site enterprise system projects is a plus.  Excellent communication skills with the ability to interface effectively with senior management, interdisciplinary project teams, subordinates and external vendors.  Experience leading cross-functional project teams is required.  Strong financial planning, budgeting, risk analysis and forecasting skills is required.Superior computer skills required.  Must be experienced with word processing, spreadsheet and database applications, including MS Project and MS Office (Word, Excel, PowerPoint, Outlook), used to support contract administration and management.