Associate Director, Investigational Product Preparation and Strategy

Purpose

Within the CMC Portfolio Strategy group, the Associate Director, Investigational Product Preparation and Strategy will lead activities related to use of investigational products used in the conduct of clinical trials to ensure consistent program deliverables including the investigational product preparation and administration instructions (IPPI) across our diverse portfolio.

Responsibilities

• Leading a cross-functional team accountable for creating the IPPI to ensure that best practices for Investigational Product (IP) preparation and administration are incorporated in our processes and look for opportunities to improve the process.
• Ensuring 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.
• Providing consultation and lend expertise across J&J Innovative Medicine to ensure the safe and accurate delivery of our portfolio at clinical sites 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.
• Seeking opportunities for team or product development improvements across the TDS organization.
• You may also support or lead 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.
• Working in a multi-disciplinary, complex and innovative environment, delivering IP strategy and documents across Therapeutic Areas and the development process, including early, late and LCM development.

Qualifications / Requirements

• A bachelor's degree in nursing, a Doctor of Pharmacy/PharmD, or international equivalent is required; Active clinical license as a nurse or pharmacist is required
• 10+ years' experience in a patient care setting as a nurse or pharmacist with detailed knowledge of United States Pharmacopeia (USP) requirements for investigational agents is required
• Experience in implementing strategies for the safe and accurate delivery of investigational products in a clinical setting is required
• Extensive experience in the preparation and/or administration of both investigational and commercial agents is required
• Excellent communication skills, both oral and written, as well as proven conflict management and negotiation skills are required
• Excellent interpersonal skills with the ability to adapt effectively to constantly evolving organization issues, structures and dynamics are required
• Demonstrated capability to manage multiple projects is required
• 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 is required
• Influencing ability without line authority is required