Director, Global Project Management, Clinical Regulatory

Описание вакансии

Kite is seeking a highly motivated individual to join us as a Director, Project Management, to work in the exciting area of cancer immunotherapy. This position will provide business operations support and project management to the Clinical Regulatory team in a enthusiastic and exciting organization. The preferred candidate will possess deep interpersonal skills as this position interacts with all levels of employees in Clinical Operations, Clinical Development, Biostatistics, Patient Safety, Quality/Compliance, and Regulatory Affairs.

Are you interested in helping ensure timely implementation of clinical regulatory strategy in a cell therapy setting? Come join us in our mission to cure cancer!

Responsibilities :

• Facilitate cross-functional Regulatory Project Teams and Submissions Teams (e.g. INDs, BLAs, MAAs, CTAs etc.) and guide deliverables for on-time completion
• Partner with Regulatory CMC, Clinical Regulatory, Regulatory Operations, Regulatory Labelling, Regulatory Advertising and Promotions, and Regulatory Writing at multiple sites to ensure coordinated preparation and delivery of submissions and requests for information
• Develop submission documents including file organization, transfer between systems, and traceability from draft through approval and publishing
• Develop, deploy, and support the optimization of business processes and resources to improve efficiency and advance Regulatory-Clinical Operations interactions
• Provide effective communication and coordination with Regulatory teams and Clinical Operations teams and proactively update stakeholders on progress and issues (e.g. project dashboards, reporting)
• Mentor junior employees for complex projects

Basic Qualifications:

• Doctorate and 8+ years of biotech or pharmaceutical industry experience OR
• Master’s and 10+ years of biotech or pharmaceutical industry experience OR
• Bachelor’s and 12+ years of biotech or pharmaceutical industry experience OR
• Associate and 14+ years of biotech or pharmaceutical industry experience OR
• High School Diploma/GED and 16+ years of biotech or pharmaceutical industry experience

Preferred Qualifications:

• Project Management certification or equivalent is preferred
• Experienced managing multiple complex projects simultaneously and resolving conflicts related to meeting numerous deadlines
• Knowledgeable with the drug development process, cell therapy industry, and Regulatory practices; eCTD submission experience highly preferred
• Ability to take initiative and think critically with demonstrated troubleshooting and problem solving skills
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
• Comfortable negotiating and influencing in a exciting, passionate, highly fluid, matrixed global organization and able to adjust workload based upon changing priorities
• Proficient in MS Word, Excel, Power Point, SharePoint and Outlook; MS Project, Documentum, document formatting instruments experience a plus

Does this sound like you? If so. apply today!