Senior Medical Manager, Clinical Science, Oncology (MD)

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 – MD

Job Category:
People Leader

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

Additional Job Description

• Provide clinical leadership in JP project team to evaluate JP clinical inputs/recommendation to  global clinical development strategy.

Work closely with Regulatory, Project leader, and other functions.

• Work closely with colleague clinical leaders/global medical head in TA ONC to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development in close collaboration with key functional stakeholders.

• Lead the clinical part of PMDA/MHLW interactions.

Working closely with Medical Writing, responsible for the clinical related regulatory document development, ensure the strong evidence based clinical logic is in place to support company position.

Responsible for the clinical strategy alignment within TA ONC and with other function stakeholders.

• Lead the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program.

•Represent the clinical program to interact with clinical investigators, key opinion leaders and business partners such as for CDx development.

• Work with the compound Clinical Leader to support the development and compilation of JNDA and to support responses to PMDA questions and PMDA presentations post-filing.

• May review/co-author medical publications emerging from clinical trial results.

• May be asked to assess and plan for external clinical research opportunities in collaboration with compound Clinical Leader and BD.

• May interact with medical consultants in concert with senior clinical staff, in conducting IDMC and Investigator meetings as well as Advisory Boards.

• Provide support for clinical study/studies within a development program including:

o Working closely and support the SRPs and clinical project scientists to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real time review of serious adverse events and deaths.

o Collaborate with the compound Clinical Leader and Clinical Project Scientists on key study design elements.

o Support SRPs to address protocol questions from He...