Associate Director, Investigational Product Preparation and Strategy

About the role

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

• Job Function: Discovery & Pre-Clinical/Clinical Development
• Job Sub Function: Biotherapeutics R&D
• Job Category: Scientific/Technology

All Job Posting Locations: Raritan, New Jersey, United States of America

You will be responsible for

• 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.

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

#LI-Remote

Preferred Skills

Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Collaboration, Data Synthesis, Drug Discovery Development, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Program Management, Scientific Research, Tactical Planning, Technical Credibility

The anticipated base pay range for this position is

$140,000.00 - $241,500.00

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation -120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year

Holiday pay, including Floating Holidays -13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

• Caregiver Leave - 80 hours in a 52-week rolling period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year