Senior Manager, Clinical Sciences 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 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:

Beerse, Antwerp, Belgium, Los Angeles, California, United States of America, Spring House, Pennsylvania, 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. 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

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.

The Senior Manager, Clinical Sciences Oncology (Early Development) works in the Oncology Therapeutic Area Early Development (ED) group and reports to the ED Oncology Clinical Project Scientist. The preferred location for this role is Spring House, PA but consideration could be given to other locations including Los Angeles, CA and Beerse, Belgium. Remote work options may be considered on a case-by-case basis and if approved by the company.

The Senior Manager, Clinical Sciences Oncology has the following essential job functions: 

• Scientific responsibilities will include internal activities such as interpreting clinical endpoints for topline results, participating in preparing Clinical Study Reports and in Disease Area Stronghold and Compound Development Team activities. External scientific collaborations will include interacting directly with academic investigators, coordinating clinical presentations at scientific meetings, and facilitating scientific publications in a timely manner.  

• As Study Responsible Scientist (SRS), will work together with the Study Responsible Physician (SRP) and GCDO Trial Leader (GTL) in the Core Clinical Team for the efficient initiation and execution of early phase clinical trials.  

• Work within the cross-functional ED Clinical Team collaborating closely with the SRP and the ED Project Scientist Leader to plan and execute patient-oriented oncology ED clinical trials 

• Participates in writing protocol synopses, full protocols, informed consent documents, and will help design Case Report Forms (CRFs) and other data collection tools.  

• Provide input to the Statistical Analysis Plan, the Data Management Plan, and the Safety Management Plan.  

• In collaboration with the SRP, prepare the Medical Review Plan. 

• Participate in investigator meetings, pre-trial assessment visits (as needed) and site initiation visits.  

• Participate in study start-up activities including site selection, review of vendors’ scope of work contracts, timelines, and management of study close out activities. 

• For ongoing clinical trials, the SRS will review all incoming clinical data in real time including patient screening results, PK/PD data, adverse events and other study endpoints and will perform medical review activities in collaboration with the SRP.  

• Maintain adherence to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) guidelines. 

• Work closely with other key support areas including Global Clinical Operations, Translational Research, Medical Writing, Regulatory Affairs, Project Management, Biostatistics & Programming, and Clinical Pharmacolo