About the Role
The Associate Director, Investigational Product Preparation and Strategy is responsible for leading activities related to the use of investigational products in clinical trials. This includes ensuring consistent program deliverables, including investigational product preparation and administration instructions (IPPI), across our diverse portfolio.
The successful candidate will have a strong background in patient care, preferably as a nurse or pharmacist, with detailed knowledge of United States Pharmacopeia (USP) requirements for investigational agents. They will also have extensive experience in implementing strategies for the safe and accurate delivery of investigational products in a clinical setting.
Key Responsibilities:
* Create IPPI to ensure best practices for IP preparation and administration are incorporated in our processes and identify opportunities for improvement.
* E nsure our approaches are consistent with clinical site research pharmacy and nursing practice to ensure patient safety in compliance with applicable regulations, international standards, good clinical practices, and institutional policies and procedures.
* Provide consultation and lend expertise across J&J Innovative Medicine to ensure the safe and accurate delivery of our portfolio at clinical sites and serve as the CMC point of contact for IP preparation and administration.
* Contribute to the CMC portfolio management team tracking milestones for reporting to senior management.
Requirements
To be considered for this role, you will need:
* A Bachelor of Science in Nursing, Doctor of Pharmacy, or international equivalent.
* A minimum of 10 years recent experience in a patient care setting as a nurse or pharmacist with detailed knowledge of USP requirements for investigational agents.
* Experience in implementing strategies for the safe and accurate delivery of investigational products in a clinical setting.
* Extensive experience in the preparation and/or administration of both investigational and commercial agents.
* Excellent communication skills, both oral and written, as well as proven conflict management and negotiation skills.
* Excellent interpersonal skills with the ability to adapt effectively to a constantly evolving organization issues, structures, and dynamics.
* Demonstrated capability to manage multiple projects.
* Ability to make difficult decisions in a timely fashion along with excellent follow through and organizational skills to assure team and organizational alignment to these decisions.
* Influencing ability without line authority.
* An active clinical license as a nurse or pharmacist.
We Offer
J&J Innovative Medicine is an equal opportunity employer and welcomes applications from qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. We actively seek to provide an inclusive interview process that meets the needs of all applicants.