Veröffentlicht am 31st Juli 2019
Principal Project Manager – New Product Development
Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.
Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide.
At Curium, every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”. We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration. Come grow with us!
Summary of Position
The Principal Project Manager – New Products will work in a dynamic organization in the Project Management Office (PMO) for North America. This role has the responsibility for supporting and implementing projects related to Curium’s business strategy in the space of reactor and cyclotron derived new products. The Principal Project Manager will report to a Director of New Product Development. Although this role largely supports new products, the Project Manager may support or execute projects in other PMO spaces such as capital projects. Projects can include technical transfer, drug development, scoping, integration, etc.
The Principal Project Manager maintains complete cross-functional responsibility for facilitating and managing completion of all required elements of the global project strategy. This includes elements from Marketing, Manufacturing, Quality, Logistics, Product Monitoring, Legal, R&D, Finance, Clinical and Regulatory. The Principal Project Manager works in collaboration with the Technical Leader and is responsible for assuring that the team members from all disciplines are completing the identified tasks to successfully launch a global product. These responsibilities are carried through until product validation and launch.
- Support and/or lead the most critical and complex cross-functional projects and project teams with minimal outside support.
- Responsible for establishing and managing the project scope, critical path and budget.
- Perform detailed risk and financial analyses to identify and present the best project portfolio alternatives to the executive committee.
- Utilize project management tools, software and best practices to quickly move projects from scoping to implementation.
- Provide and maintain forecast estimates for project related costs and general project task tracking for adherence to project milestone goals.
- Maintain complete cross-functional responsibility for facilitating and managing completion of all required elements of the project strategy including Marketing, Manufacturing, Quality, Logistics, Product Monitoring, Legal, Finance, Clinical and Regulatory.
- Understanding of cost accounting related to product development, must understand intermediate accounting terminology and practical usage such as budget adherence, forecasting, accruals, reversals, plan vs actuals, NPV, IRR, EBITDA, and Free Cash Flow.
- Develop the project Risk Management Plan including upsides, contingencies, and mitigations Responsible for developing products under the structure of Curium Pharmaceuticals Development Procedures and FDA guidelines.
- Demonstrates ability to mentor others and is seen as the “Go to Person” for challenging initiatives and technical advice.
- Estimates resources and timing while creating project development plans and negotiates team assignments with functional managers.
- Develops the project schedule with the core team and establishes stakeholder buy-in to key milestones. Ensures PERT analysis is conducted on schedule and cost to obtain probability and sensitivity analysis when presenting the schedule to management.
- Effectively facilitates and manages team meetings and assures that proper communication regarding the project is appropriately elevated and distributed (including presenting at key project stage and other reviews).
- Bachelor Degree in Chemistry, Engineering or related field. Advanced degree preferred.
- PMP certification or related project management certificate / coursework required.
- 10 years project management experience in the pharmaceutical industry required. This should include clinical trials and working in a multifunctional team environment. Experience in the radiopharmaceutical industry and operations preferred.
- Technical understanding of the pharmaceutical development process from concept to launch; preferably in finished dosage products
- Knowledge / experience in aseptic / terminally sterile operations; isolator technology, tech transfer and scale up techniques with experience in manufacturing operations preferred.
- Expert in project management tools and best practices, strong project management and organizational skills, including ability to work independently and as a team member.
- Experience in leading all project stages of new drug development (ANDAs and NDAs) preferred.
- Advanced knowledge of FDA Pharmaceutical Guidelines and Submission Requirements.
- Ability to effectively handle conflict through proactive action and direct and timely communication.
- Demonstrated attention to detail and experience to check behind the scenes to ensure surprises are minimized.
- Proven ability in setting priorities and organizing work to meet deadlines. Strong organizational and planning skills.
- Proven experience in leading complex multi-discipline project teams in a highly regulated environment.
- Ability to react to problems and lead the team to develop solutions while communicating effectively to the executive team.
- Ability to create PowerPoint presentations to senior leadership on a regular basis.
- Proven track record of developing accurate project budgets and schedules and reporting them via various tracking mechanisms.
- Ability to maintain collaboration in a results driven environment. Skilled in leadership and collaboration abilities.
- Successful candidate shall have a working knowledge of Regulatory Affairs requirements and be able to support filing efforts.
- Successful candidate will have global experience working with international teams and locations.
- Experience managing outside contractors, to include developing a Statement of Work and Purchasing Agreement, financial and goal tracking, and ensuring contractors provide required deliverables on time.
- Agile approach and willingness to learn new things – ability to work “on the fly” in a dynamic setting.
- Excellent interpersonal skills with demonstrated ability to work within a global team.
- Advanced skills with Microsoft Office (Excel, PowerPoint, SharePoint, Word), MS Project and Visio; experience with Smartsheet is preferred.
- Travel may be required up to 25% of the time.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.