This position is located in our MD, Frederick facility
Manages and is responsible for the successful completion of all tasks in assigned program area including technical work, staff supervision, financial and business development activities. At this level, the position is typically responsible for managing 25-50 employees both exempt and non-exempt and including one or more subordinate supervisors - working on multiple projects and tasks.
1. Provide direct support to the USAMMDA Teams Contract.
2. Have specific knowledge of the Project and Product Manager roles within USAMMDA.
3. Possess a technical knowledge and understanding of the Integrated Product Team (IPT) environment. This is a multidisciplinary group of people who are collectively responsible for development and delivering a defined medical product for the Warfighter.
4. Possess a thorough understanding of the following:
• Product Management
• Project Management
• Clinical Drug Development
• Clinical Trials Management
• Lifecycle Product Management
• Regulatory Strategy Development including understanding FDA guidance's and how to navigate through the FDA drug development process.
• Decision Gate Pathway and how this integrates with the IPT.
• New Drug Application process with regulatory agencies
• Contract Research Organizations (CRO)
• Contract Manufacturing Organizations (CMO) and how the IPT interacts with these groups.
• Fiscal tracking of obligations and disbursements per business plans used at USAMMDA.
• Project management time schedules and Gantt charts for valid product requirements, based on input from the various sub-project leaders, outside consultants, and key USAMRMC staff. Developing resource source lists and linkages to development schedules.
• Administrative and scientific staff at USAMMDA, contracting personnel, budget personnel, funded executing institutions, and principal investigators.
• Budget documents for requirements
• Conducting research and gathering technical data for white papers, information papers, reports, memorandums and briefings.
• Experience and understanding in developing product and acquisition strategy for products heading to the FDA.
• In-Process Review briefings to Senior USAMMDA leadership, Planning and Lifecycle Review Committee and Executive Management Committee.
4. Interface and be familiar with the administrative and scientific staff at USAMMDA, contracting personnel, budget personnel, funding executing institutions, and principal investigators so as to understand, support and improve the product development process, communication of advanced development product oriented information.
5. Work with personnel from the US Army Medical Research Acquisition Activity Subordinate Command in support of contract actions that tie directly to contracts under PM management.
6. Provide expert assistance to USAMMDA Senior Management by liaising with USAMMDA's Office of the Commander, Administrative Services Division, Pharmaceutical Systems Project Management Office, Armed Forces Institute of Regenerative Medicine Project Management Office, Neurotrauma and Psychological Health Project Management Office, Medical Support Systems Project Management Office, Hyperbaric Oxygen Treatment Project Management Office, Force Health Protection Division, Division of Regulated Activities and Compliance, Clinical Services Support Division.
7. Significant experience in providing advice and counsel to senior level management on activities that directly support acquisition planning and management, budget and cost analysis.
8. Significant understanding of Headquarters organizational-level taskers, reports and briefings tied directly to USAMMDA.
9. Manages and is responsible for the successful completion of all tasks in assigned program area including technical work, financial and business development activities.
10. Supervises assigned technical and administrative staff, including subordinate supervisors, and performs personnel actions including hiring and performance evaluation.
11. Directs program activities to meet client and organization work objectives and serves as a liaison with clients to coordinate activities, negotiate tasks, and solve problems.
12. Responsible for profitability and revenue growth of assigned program(s).
13. Assures quality of program products, services, and deliverables, including participating in reviews, audits, and site visits.
14. Performs business development activities, including the preparation and review of technical and cost proposals.
15. Performs program financial management services, including financial analysis, budget and cost quote preparation, cost management, reconciliation, and profit enhancement.
16. Coordinates and monitors sub-contractor activities and administers subcontractor deliverables and finances.
17. Develops, reviews, and approves plans, schedules, consulting agreements and other program documents.
18. Prepares and provides various reports and technical reviews to senior management as requested.
19. Ensures compliance with relevant corporate and government policies and standards.
20. Participates in special projects as required.
Bachelor's degree in a Scientific, Health or Biologic Sciences related field. Professional certification (PMP) is preferred. Completed requirements for Acquisition IPT Management through Level II preferred. Professional certification (PMP) preferred.
10 - 15 years of experience in the field of technical program management, contract management, and business development within a program similar in complexity to the work. Possess a keen understanding of scientific issues, developmental logistics, financial acumen, and be familiar with information products including packages and briefings to the various Government Product Managers. 10 - 15 years' experience in Pharmaceutical, Biotech and clinical fields. Excellent interpersonal communication skills; proven ability to effectively communicate and interact with product managers, scientists, project managers, contractors, and senior managers in scientific and governmental agencies.Click Here to Apply