“The Project Manager Companion Diagnostics (CDx) Implementation will work in close collaboration with the project lead/s and will be responsible for overall coordination and process management related to planning and implementation of CDx global CDx program.
- This individual will collaborate in the planning, implementation and execution of activities related to the CDx programs globally for the gene therapy program
- This individual will support the day-to-day operations, acting as a liaison with vendors handling CDx activities (eg logistics partners, lab partners) globally.
- This individual contributor will serve as a liaison within the internal ARUP department and among the members of the global and regional CDx cross functional implementation teams
- This individual will play a pivotal role in managing timelines and deliverables for key CDx milestones for the company.
- This individual can effectively apply project management related support to meet overall corporate objectives in building a compliant and effective CDx program globally.
This individual will serve as a representative who collaborates with colleagues towards a global, compliant, shared, single system CDx program (with regional variations as needed).”
Education Needed: A minimum of an MS/MBA degree is preferred. Formal Project Management training/education preferred.
(Although I expect there can be flexibility for the right individual)
- 5-7 years previous experience in or working directly with Pharmaceutical/Biotech/Device Industry
(Operations, Project Management, Medical/Scientific Affairs, Regulatory, Clinical Development, Safety/Pharmacovigilance or relevant disciplines)
- Experience working in regulated environment
- Advanced skills in MS Word, Excel, and PowerPoint.
- Understanding of laboratory diagnostics, with experience in companion diagnostic implementation (preferred)
- Project Management experience
- Data analytics knowledge and experience
- Experience working in global environment
- Proficient in use of web based IT systems and Microsoft (MS) Excel, MS PowerPoint, and MS Word
- Experience using project management software (e.g. MS Project)
- Ability to effectively use automated systems and computerized applications
- Very good knowledge of regulatory requirements for research conduct (i.e. Good Clinical Practice, International Conference on Harmonization (ICH) guidelines, etc.)
- Excellent working knowledge of clinical research/development, including medical and therapeutic areas, phases and medical terminology
- Knowledge of CRO/Pharmaceutical functional departments and responsibilities