Director, Investigational Product Preparation and Strategy (IPPI)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Pharmaceutical Product R&D

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Director, Investigational Product Preparation and Strategy to be located in Raritan, NJ.

Purpose:

Within the CMC Portfolio Strategy group, the Director leads the team working on activities related to the use of investigational products used in the conduct of clinical trials to ensure consistent program deliverables including the development/authoring of the investigational product preparation and administration instructions (IPPI) across our diverse portfolio. This team creates the IPPI to ensure that best practices for IP preparation and administration are incorporated in our processes and look for opportunities to improve the process. The Director ensures our approaches for preparation and administration 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. The director provides consultation and lend expertise across J&J Innovative Medicine to ensure the development strategy ensures the safe and accurate delivery of our portfolio at clinical sites and will be the CMC point of contact for IP preparation and administration. The Director also contributes to the CMC portfolio management team tracking milestones for reporting to senior management.

You will be responsible for:

• overseeing the creation of the IPPI to ensure that best practices for IP preparation and administration are incorporated in our processes and look for opportunities to improve the process
• developing and delivering IP strategy and IPPI documents across Therapeutic Areas in the development process, including early, late and LCM development
• ensuring consistent approaches are consistent with clinical site research pharmacy and nursing practice in compliance with applicable regulations, international standards, good clinical practices, and institutional policies and procedures
• being the people leader of the IPPI team
• providing consultation and lend expertise across J&J Innovative Medicine to ensure delivery of our portfolio and will be the CMC point of contact for IP preparation and administration.
• contributing to the CMC portfolio management team tracking milestones for reporting to senior management
• seeing opportunities for team or product development improvements across the TDS organization
• leading teams in implementing initiatives to deliver organizational or process improvements
• demonstrating behaviors consistent with the current Leadership Imperatives and will be mentoring and coaching team member to improve their skills and contributions to the organization in collaboration with line management

Qualifications / Requirements:

Education:

• A minimum of a Doctor of Pharmacy or international equivalent is required

Required:

• a minimum 10 years of recent experience in a patient care setting as pharmacist involved in the preparation or administration of investigational agents with detailed knowledge of United States Pharmacopeia (USP) requirements for investigational agents is required
• a mini