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Requisition Number 18-0006
Post Date 9/14/2018
Title Sr Mgr or Assoc Dir Project Management/Strategic Alliance
City Mountain View
State CA
Description Responsibilities:

Project Management
• Manage multiple Alexza R&D projects internally and with corporate partners
• Work efficiently across multi-disciplinary teams, including pharmaceutical development, device development, manufacturing, regulatory and quality
• Generate and manage overall project schedules to minimize resource utilization conflicts and ensure timely completion of milestones
• Track progress against plans for the various activities, identify areas of schedule risk and recommend a solution
• Coordinate between cross-functional groups and between projects to identify hurdles and facilitate resolution to ensure efficient progress in the project
• Establish and maintain design history files for development projects, including the preparation of key project documentation such as the device development plan and essential outputs document to ensure compliance with FDA Design Controls and cGMP requirements for combination medical products
• Manage and drive the generation of risk management documentation (risk management plan, hazards analyses, failure mode and effects analyses) for development projects in accordance with ISO 14971
• Conduct formal project phase gate reviews, lead critical technical design reviews and project meetings and issue meeting minutes
• Follow-through on action items to facilitate timely closure
• Build and monitor project budgets
• Support the team leaders in general management of the project

Alliance Management
• Understand and track contractual obligations to ensure timely deliveries of materials and/or information to partners
• Responsible for ensuring Alexza’s team members understand obligations and timeline for meeting deliverables.
• With partners, build trust and maintain open and honest relationships through clear communication, alignment of goals and mutually acceptable solutions.
• Monitor overall health of alliance partnerships and report findings to supervisor
• Point-person to manage existing partnerships
• Successfully implement business agreements through alliance management
Requirements Skills Required:

• Extensive experience in project management in the pharmaceutical and/or medical device industry
• Scientific and technical background with strong written and oral communication skills; ability to communicate effectively internally, with corporate partners and with different levels of management
• Excellent interpersonal skills and track record of productive management of multi-disciplinary teams
• Expertise with the use of Microsoft Project, PowerPoint, Word and Excel
• Familiarity with medical device and/or drug / pharmaceutical development in a regulated environment
• Ability to balance attention-to-detail and “big picture” perspective
• Self-starter with strong problem-solving skills
• Ability to work in a fast-paced start-up environment on multiple projects within milestone-driven time lines

Education and Experience:

• BS or BA, preferably in a technical field (Chemistry, Biology, Physics, Engineering, or Life Sciences)
• Must have direct experience in medical device (combination product) development in accordance with FDA Quality System Regulations (21 CFR Part 820) and/or ISO 13485 including development of documentation to build and maintain the design history file and risk management file
• Experience in the development of inhalation products is a plus
• A minimum of 7+ years’ experience in the biopharmaceutical industry
• Understanding of product commercialization (sales and marketing)
• Hands-on experience in project and alliance management (research collaborations)

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