Senior Project Manager Corium International
The position responsibilities include developing and managing integrated and complex drug-device project plans including tasks and activities, timelines, deliverables, milestones and budget. The position will work in a highly cross-functional environment including technical, clinical, manufacturing, QA, corporate, finance and business development. The individual should be highly motivated, self-starter, with demonstrated project management experience in drug-device combination products, preferably with a bachelor's or advanced degree in science or engineering.
Develop, maintain, pro-actively track and manage a high quality, ambitious and complex integrated project plan
Effectively guide a team through the formation of a comprehensive drug-device combination project plan and budget
Manage project plans with emphasis on scientific/engineering excellence, scope compliance and adherence to timeliness and budgets
Partner with the team leader in identifying, managing and communicating key project risks and leading risk management strategies. Closely and transparently manage the critical path of the project
Maintain, track, report and understand variances in the integrated project budget by working in close collaboration with functional contributors and finance
Drive operational integration, including coordinating activities and communications involving team members and external partners
Identify issues and facilitates problem-solving, contingency planning, and decision-making; Inform key stakeholders of status, issues, problems, and proposed solutions as appropriate
Develop and execute communication plan to ensure effective and timely communication between the product development, line management, senior management, and external partners
Prepares independent periodic management reports including monthly reports and project milestones
Coordinate technology transfer for scale-up, clinical supply and commercial production
Ensure compliance with current SOPs, safety and environmental regulations and cGMP
Bachelor's Degree required. Advanced degree (science/engineering, MBA) preferred
At least 7+ years of Project Management experience supporting highly cross-functional drug development teams in the pharmaceutical/biotech industry required industrial experience
Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders. Experience in interacting with technical individuals
Understanding of overall drug-device development and process, including stages of development and role of different functional areas.
Understanding of early and late phase clinical development stages, processes and decision criteria for moving programs through the development pipeline as well as considerations relevant to post-marketed development and life cycle management.
Working knowledge of the science (e.g. formulation, polymers) and/or engineering (e.g. mechanical, chemical, bioengineering) fields with technical, scientific or engineering expertise in one or more functional areas involved in product development preferred
Basic knowledge of 505(b)(2) regulatory requirements, processes and regulatory authority interactions
Strong expertise in use of project management software solutions, including skills in critical path analysis. Demonstrates judgment in selecting methods and techniques for obtaining solutions.
Understanding financial and resource planning systems and processes and ability to coordinate project-level budget/resource estimates and manage actual vs. plan
Ability to work in a matrixed organization with non-colocated teams; proven ability to get things done without formal authority
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Menlo Park, CA 94025