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:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Dublin, Ireland

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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, 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

The Manager, Clinical Sciences Early Development (Hematology) works in the Oncology Therapeutic Area Development group, and participates in the development, oversight, and execution of Ph 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.

The Manager, Clinical Sciences Early Development (Hematology) has the following essential job functions:

Essential Functions:

For ongoing clinical trials, this individual in collaboration with the Study Responsible Physician/other Clinical Project Scientists, will 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
May participate in drafting protocol synopses, sections of full protocols, informed consent documents, and will review Case Report Forms (CRFs) and other data collection tools against draft protocols and central vendor scope of work
May partner with the lead CPS/Cross Functional Trial Team to mitigate issues in initiation of clinical trials and may participate in review of Monitoring Guidelines, SET/IDMC Charter, Statistical Analysis Plan, Data Management, and Safety Management Plans
May perform medical monitoring/reporting, evaluates ongoing clinical trial data
May partner with the lead CPS drafting Medical Review Plan and Medical Review Forms
May liaise with vendor laboratories, Translational Research lead, pharmacokinetic operations and/or biomarker operations to ensure sample collection, processing, and tracking
May liaise with Integrated Data Analysis & Reporting team in set-up of data visualization tools (e.g., iDARTs)
May participate in or lead aspects of training 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
May participate in data review and drafting documents for Health Care Authority interactions.
Will actively participate in mentorship and training 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, with advance degree (i.e., MSc, Ph.D., or Pharm D) preferred
A minimum of 4 years of experience in a related clinical research position is required, spending at least part of the time within the pharmaceutical industry, is preferred.

Knowledge of scientific research with an understanding of applications to 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 required.
Fluent in written and spoken English with excellent communication skills is required.
Working knowledge of the use of Microsoft suite of software products is required.
Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for the conduct of high-quality clinical trials including protocol development, medical review, oversight of study conduct, data quality and safety is preferred
Ability to travel approximately 10% domestic/international travel may be required.

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 & Johnson 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, external applicants please contact us via https://www.jnj.com/contact-us/careers Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management