Job Summary
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 & Sub Function
Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Clinical Development & Research – Non-MD
Job Category: Scientific/Technology
Locations
* Dublin, Ireland
Position Overview
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
We recommend focusing on the specific country(s) that align with your preferred location(s).
* USA - Requisition Number: R-041721
* Belgium - Requisition Number: R-043114
* Ireland - Requisition Number: R-042966
Team & Responsibilities
The Manager, Clinical Sciences Early Development (Hematology) works in the Oncology Therapeutic Area Development group, and participates in the development, oversight, and execution of Phase I-IV clinical research trials working closely with Study Responsible Physicians and other Clinical Project Scientists. The position reports to a more senior Clinical Project Scientist.
Essential Functions:
* Collaborate with the Study Responsible Physician or other Clinical Project Scientists to participate in or lead aspects of aggregate and participant level data, including patient screening/eligibility evaluation, PK/PD data, adverse events, efficacy, coding, and other data critical to study endpoints.
* Draft protocol synopses, sections of full protocols, informed consent documents, and review Case Report Forms (CRFs) and other data collection tools against draft protocols and vendor scope of work.
* Partner with the lead CPS/Cross Functional Trial Team to mitigate issues in initiation of clinical trials and review Monitoring Guidelines, Statistical Analysis Plan, Data Management, and Safety Management Plans.
* Perform medical monitoring/reporting and evaluate ongoing clinical trial data.
* Draft Medical Review Plan and Medical Review Forms.
* Liaise with vendor laboratories, Translational Research lead, pharmacokinetic operations, and biomarker operations to ensure sample collection, processing, and tracking.
* Collaborate with the Integrated Data Analysis & Reporting team to set up data visualization tools (e.g., iDARTs).
* Train the central study team, local study team, site personnel or external vendors on protocol, disease evaluation criteria, or other specific aspects of the clinical study.
* Review and draft documents for Health Care Authority interactions.
* Mentor and train opportunities to expand clinical development knowledge, therapeutic area expertise, and leadership capabilities.
Qualifications
* Minimum of a bachelor’s degree in a scientific discipline is required; an advanced degree (MSc, Ph.D., or Pharm D) is preferred.
* A minimum of 4 years of experience in a related clinical research position is required, with at least part of the time spent within the pharmaceutical industry.
* Knowledge of scientific research and its application to drug development.
* 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.
* Fluent in written and spoken English with excellent communication skills.
* Working knowledge of Microsoft suite of software products.
* Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for high‑quality clinical trials including protocol development, medical review, oversight of study conduct, data quality and safety.
* Ability to travel approximately 10% and domestic/international travel may be required.
Equal Opportunity Statement
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Jonsen is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers. Internal employees should contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr