Senior Principal Scientist, Investigational Product Preparation Strategy

Job Description

Lead activities related to the utilization of investigational products in clinical trials, guaranteeing consistent program outcomes. Develop the Investigational Product Preparation and Implementation (IPPI) to integrate optimal methodologies for investigational product preparation and administration into our workflows. Ensure our strategies align with clinical site research pharmacy and nursing practices to prioritize patient safety while adhering to relevant regulations, international benchmarks, good clinical practices, and institutional guidelines. Provide expert guidance across Johnson & Johnson Innovative Medicine, ensuring the secure and precise delivery of our products at clinical sites. Contribute to the CMC portfolio management team, monitoring milestones for senior management reporting. Identify opportunities for team or product development enhancements across the TDS organization. Support or manage teams in executing initiatives aimed at organizational or process improvements. Embody behaviors consistent with current Leadership Imperatives and mentor team members.

Qualifications

1. A Bachelor of Science in Nursing, Doctor of Pharmacy, or its international equivalent is necessary. 2. A minimum of 10 years of recent experience in a patient care setting as a nurse or pharmacist, with in-depth knowledge of United States Pharmacopeia (USP) requirements for investigational agents, is required. 3. Experience in implementing strategies for the safe and accurate delivery of investigational products in a clinical setting is required. 4. Extensive experience in the preparation and/or administration of both investigational and commercial agents is required. 5. Excellent communication skills, both oral and written, as well as proven conflict management and negotiation skills are required. 6. Excellent interpersonal skills with the ability to adapt effectively to constantly evolving organizational issues, structures, and dynamics are required. 7. Demonstrated capability to manage multiple projects is required. 8. Ability to make difficult decisions in a timely manner, along with excellent follow-through and organizational skills to assure team and organizational alignment to these decisions, is required. 9. Influencing ability without direct authority is required. 10. An active clinical license as a nurse or pharmacist is required.

Benefits

- Flexible work arrangements - Professional development - Inclusive work environment