Senior Manager, Japan Clinical Pharmacology Lead
Genmab
ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。
The Role
Japan Clinical Pharmacology Lead will serve as the pre-clinical and clinical pharmacology lead on a number of pre-clinical and clinical development programs providing quantitative sciences support and execution of Japan clinical development plans that include characterization and prediction of pharmacokinetics and pharmacodynamics of the drug candidate. This individual will also work in close collaboration with scientists in Translational Research and Clinical Development to conduct quantitative PK/PD/safety/efficacy analyses for integration into overall program strategies at local and global, as applicable. This person will provide rationale for dose regimen selection in FIH (First-in-Japanese) trials and beyond, and identification of circumstances where dose adjustment or patient selection/stratification should be considered.
The person will be responsible for all aspects of quantitative modeling & simulation strategies for candidate drug products from early development (pre-IND) through late-stage development using model-based approaches to improve the efficiency of drug development, improve our mechanistic understanding and support dose selection, as applicable for Japan development.
Additionally, this role may support also tasks or activities to support global projects, if needed.
This is an exciting opportunity to be part of a passionate, high-impact Clinical Pharmacology & Quantitative Science and Japan development team, and work in a highly dynamic and collaborative setting.
Key Accountabilities
Provides pre-clinical and clinical pharmacology support on multi-disciplinary study teams for pre-clinical and clinical programs in Japan (and global, if applicable)
Contributes expert pharmacology input into key pre-clinical, clinical and regulatory documents including study protocols, study reports, investigator brochures, and other regulatory documents and submissions within agreed timelines
Leads Japan clinical pharmacology efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions.
Using modeling-based approach, accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan and interpreting results, as applicable.
Develops PK/PD modeling and simulation plans to guide rational first in human dose projection and dose selection, if applicable.
Represents Japan at Global Clinical and Pre-Clinical Development Teams as Clinical Pharmacology representative and provides a source of Clinical Pharmacology expertise and advice to other functions across the Company
Coordinate with clinical and translational quantitative science teams on strategic priorities and study support, as applicable.
Performs other responsibilities as requested by management
Ensure effective and continued collaboration with global counterparts and other relevant functions within R&D.
Team lead & management of Japan clinical pharmacology, if applicable.
Skills & Experience
A PharmD or PhD in Clinical Pharmacology, Pharmacology, Pharmacokinetics, or related discipline with at least 5 years of experience in Clinical Pharmacology and/or pre-clinical PK is required Experience with modeling and simulation approaches to enable rational and efficient preclinical and clinical drug development are required.
Experience with PK/PD, allometric scaling, analysis and translational modeling of preclinical PK/PD data, and mechanism-based PK/PD systems using preclinical and/ or clinical data with biologics therapeutics is preferred.
Experience of electric data submission to PMDA is preferred.
Extensive experience and strong understanding of oncology drug development is preferred
Flexible, with positive attitude, ability to work with multidisciplinary teams, prioritize projects effectively and communicate at all levels within the company
Excellent written, verbal and interpersonal communication skills
Domestic and international travel will be required.
Japanese native level and business level English skills (oral and written)
Valid permanent residency in Japan
Native level Japanese in verbal, reading, & writing
#LI-DNP
私たちは、社員ひとり一人が共通の目的に向かって、高い志を持ち、お互いを尊重し、共通の価値観をもとに日々仕事をしています。私たちの価値観の一つである誠実さを胸に、革新的な抗体治療薬の創薬に一人ひとりが主体性をもち取り組んでいます。ジェンマブでは、がん患者さんの人生をより豊かにすることを目的に、部門や国境を超え、世界中の深い専門知識を有した仲間たちと共にがん治療の将来に変革をもたらすこれまでにない経験をしていただけると信じています。
互いを尊重して協力し合うチームワークは、ジェンマブの重要な企業文化であり、そのため世界中の社員が、インクルーシブ、オープン、協力しあう姿勢を大切に日々仕事をしています。地域、教育、文化、国籍、年齢、性別などを超えた多様性を推進し続けていくことが、企業が継続して成長していくために重要であると考えています。そのため採用においても、性別、年齢等に関わらず、スキルや能力をもとに多様性を重視し進めています。
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