Associate Director, Clinical Project Scientist, Oncology

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:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

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.
Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.
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

The Clinical Project Scientist is responsible for the design, planning, implementation, monitoring, and reporting of clinical research trials.

The following responsibilities will be demonstrated in varying degrees of participation and leadership:

• Partners with Study Responsible Physician (SRP) to provide clinical oversight to the study;

• Develops clinical research protocols, study case report forms, informed consent;

• Develops the medical review plan to support the statistical analysis plan;

• Plays a key role in the medical review of the study data and assists in coding, analysis and documentation

• Validates and interprets results of phase II - IV investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals

• Ensures team member adherence to clinical research guidelines and safety procedures;

• Communicates detailed outcomes and results of research findings to relevant partners;

• Provides input in managing project budgets and projections;

• Serves as liaison  to global clinical sites for medical questions related to the clinical research trial ;

• Presents study status at internal/external meetings, including investigator meetings and governance committees

• Trains and mentors local/central study teams and investigative sites on the study protocol, ensuring they have the necessary guidance and tools for performance of various project activities

• Participates in/leads interactions with health authorities;

• Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies;

• Reviews and maintains correct standard operations, procedures and protocol

Qualifications - Internal

• A Master’s Degree, Ph.D., Pharm.D., or a B.A./B.S. with commensurate exceptional clinical research experience is required.

• A minimum of 3 years of industry experience in Oncology.  

• Significant knowledge of basic and translational research with an understanding of applications to cancer drug development is required.

• The ability to work in a matrix team environment and adherence to the highest personal and ethical standards with a commitment to patient-centered clinical research is require