Clinical Program Manager - Drug Dvelopment

Medical Device/ Pharmaceutical Company.

ooking for a candidate that has planning experience and can show that they have experience with the executive of the entire process of drug development/ clinical trials. Plainsware or any project planning software experience is necessary 

clinical project manager experience in pharma/consumer development. hands on project planning for clinical milestones. Candidate that understands the complexity of clinical trials and be able to plan accordingly. 

Position Overview: 

• The Manager, Program Coordination provides coordination support to the Clinical functional teams as assigned to ensure completion of deliverables that are balanced for quality, timeliness and resources. Assists Program Manager in providing planning and resource management support to the Compound Development Teams (CDTs). Facilitates team communications by maintaining and tracking cross-functional timelines, deliverables, and milestones including cross-project dependencies. Ensure project schedules, resources and underlying assumptions are integrated and aligned across functions. Facilitates critical path analysis and optimization planning. Assists team in determining schedule and resource requirements. Conducts contingency planning/scenario analyses to modify schedule to keep project on track. Tracks team performance metrics. Facilitates communication with the teams. Utilizes scheduling, resource management tools, provides coordination expertise and maintains cross-disciplinary process and project knowledge. 

Position is a member of the following teams: 

• Project Management Teams 

• CLIN Teams 

• Phase 1 Working Groups 

• Phase 3 Working Groups 

• GSO review meetings 

Positions which report into the position: 

• N/A 

Primary Duties: 

• The Program Coordinator (PC) provides and maintains cross-functional project plans, team reports, and resource management support to ensure the completion of deliverables balanced for quality and timeliness. 

• Assists the Program Manager in providing and maintaining system tools and Cross-functional project plans aligned across R&D (Clinical, Pre-clinical, CDO’s, CPS, Biomarker, and PDMS) to support the Compound Development Teams (CDTs). 

• Is a core member of the Project Management Team (PMT/OPT) 

• Assist the Clinical Program Manager in providing Clinical Cross-functional project plans aligned across the clinical functions (Clinical pharmacology -small molecule only, BaR, R&D Ops support, Reg/QA, & QC ) to support the Clinical Teams (CTs). 

• Program Team Resource Manager responsible for compiling/generating program/project resource demands. 

• Facilitates critical path analysis, contingency planning/scenario analyses and proposes strategies and solutions to modify schedule to keep project on track in collaboration with the CPM & PM. 

• Generates program reports and communications to ensure team and program alignment of deliverable expectations. 

• Provides overall support to the Clinical functional representatives to ensure completion of deliverables that are balanced for quality, timeliness and resources. Facilitates project communications by maintaining and tracking timelines, deliverables, and milestones. 

• Ensure project schedules, resources and underlying assumptions are integrated and aligned across functions and provides coordination expertise. 

• Facilitates critical path analysis and optimization planning. 

• Assists functions in determining schedule and resource requirements. 

• Conducts contingency planning/scenario analyses and proposes strategies and solutions to modify schedule to keep project on track. 

• Provide regular reports and analysis on resource demand and supply. 

• Facilitate regular review of workload and resource analyses, including business plan

Qualifications 

Education 

• B.S. or equivalent work experience required; advanced degree preferred. 

Experience 

• 5 years industry experience with at least 3 years in Drug Development and a detailed knowledge of the Drug Development process. 

• Detailed knowledge of: project planning, tracking, resource management, project planning and scheduling tools, and cross-project analyses.

Critical Competencies 

• Understanding of clinical development/trial execution required. 

• Knowledge of project planning, tracking, resource management 

• Delivery of results 

• Project management 

• Customer focus 

• Innovation 

• Communication 

• Adaptability 

10% Travel – Domestic 

Additional information: 

Clinical experience, project management experience, drug development experience