[Innovative Medicine] R&D, Group Manager(Sr. Principal Scientist), Pharmacokinetics & Drug Metabolism, Preclinical Science &Translational Safety Japan Full-time

Job Opportunity At Johnson & Johnson

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.

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

Pharmacokinetics & Pharmacometrics

Job Category

Scientific/Technology

Location

Chiyoda, Tokyo, Japan

Job Description

JOB SUMMARY:

1. Conduct 1) to 4) below in the non-clinical area.

1) Ensure appropriate studies are conducted at appropriate times to support development in Japan.

2) Ensure study results and their interpretation meet Japanese requirements.

3) Ensure resolution to all project-related problems that might affect development in Japan.

4) Ensure non-clinical submissions are of the highest scientific quality, and these are prepared within timelines.

2. Focus on self-evaluation, self-management and self-development.

3. Educate and coach the group members and make proper assignments and fair performance appraisals.

4. Plan and execute strategy of the group

5. Shape regulatory acceptance aligned with international standards through external/industry activities.

Key Responsibilities

1. Conduct 1) to 9) below in the non-clinical area.

1) Research global (e.g. JJPRD) documents and published papers and see whether or not the study items and/or results meet requirements by the Japanese regulatory authorities and see whether or not there is a critical issue against clinical studies and/or NDA's.

2) Make and discuss possible resolutions to a problem for clinical studies and/or NDAs with relevant colleagues and put the most appropriate resolution (e.g. additional studies and/or documentation) into practice.

3) Prepare high-quality non-clinical documents for clinical studies and/or NDAs.

4) Prepare high-quality non-clinical responses to inquiries for clinical studies and/or NDA's in cooperation with global, JPKK and/or external experts.

5) Provide support for preparing high-quality documents for marketing.

6) Discuss the requests for non-clinical studies from external investigators with relevant colleagues and perform joint studies if needed.

7) Provide relevant colleagues with suggestions from non-clinical perspectives.

8) Establish, maintain and improve relationship to relevant colleagues and external experts.

9) Support the group members, and check the documents and/or responses prepared by the group members in terms of science and quality

2. Make the group's objectives in line with R&D's goal and share them with the group members.

3. Assign the group members to projects and change the members if needed.

4. Give feedback and coaching to the group members and make fair performance appraisals.

Requirements

Experience/Knowledge

• Expert knowledge of the non-clinical area, advanced knowledge of non-clinical notifications/guidance/guidelines in Japan/EU/US, advanced knowledge of processes for IND/NDA, advanced knowledge of other non-clinical areas, and intermediate knowledge of clinical areas.

• Experience in non-clinical areas for more than 12 years or equivalent to the experience.

• Experience with activities outside the company or department

Skills/Capabilities

• Advanced presentation and negotiation skills with global mindset.

• Advanced communication skills in English.

• Advanced skills in managing and developing the group members, including coaching, feedback and mentoring.

Qualification/Certificate

Ph. D or Equivalent