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JOB DESCRIPTION

Manager, Senior Nonclinical Scientist

High Level Summary:

As an ADME expert for nonclinical science, lead the nonclinical-related work for development of each program in Japan from early development to JNDA filing and thereafter.

Role Description:

• Contribute to the development plan/strategy as a member of Japan Program Team (JPT) on behalf of nonclinical function team.
• Provide nonclinical input obtained from the counterpart-global R&D (Discovery, Nonclinical Safety [NCS] or Pharmaceutical Candidate Optimization [PCO]), and other functions such as Global Regulatory Science (GRS) and Program Team (GPT).
• Prepare the nonclinical-related parts of regulatory documents required for the development from start of clinical study to JNDA (New Drug Application in Japan) filing and thereafter; Investigators Brochure (IB) for CTN (Clinical Trial Notification), Common Technical Document (CTD) for JNDA, and Product Summary, Interview Form, Proper Use Guide and Educational Materials for launch and marketing.
• Make presentation or discuss with the PMDA (Pharmaceuticals and Medical Devices Agency) reviewer and IRB (Institutional Review Board) expert about nonclinical matter, and respond with scientifically justified responses to nonclinical-related queries in PMDA consultation, CTN and JNDA filing with the necessary support of global counterpart.
• Investigate nonclinical data package of global early development projects to ensure the required studies are available for starting clinical development (CTN) and filing (JNDA) in Japan. If the data were not satisfied the requirement, report to supervisor and draw up a solution plan.
• Search and evaluate update information on early-stage programs for the decision making in Japan.
• Coach the junior staff in the nonclinical-related work for development of products in Japan from early development to JNDA filing and thereafter.

Required Knowledge / Experiences:

• Comprehensive knowledge/skills of either the field of pharmacodynamics, pharmacokinetics and/or toxicology.
• Comprehensive and precise knowledge of ICH (International Conference of Harmonization) guidelines and Japanese guidelines for nonclinical studies of drugs. Knowledge of new drug development process and procedure.
• Knowledge of new drug development process and procedure.
• Skill of scientific literature preparation and QC/QA checking.
• Good understanding of project management and ability to manage timelines.
• Experience of planning and conducting nonclinical studies in either fields and preparation and review of a study report.
• Experience of CTN and filing related documents (IB and CTD).
• Experience of communicating with the PMDA reviewer and IRB expert.
• Experience of launching more than one drug product as JPT member from CTN to filing.
• Good communication skills in both Japanese and English.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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