Top Global Pharmaceutical Company
- To provide a key fulcrum of bidirectional translational research in Neuroscience
- To facilitate a seamless transition of assets through the Company's Neuroscience (Neurology / Psychiatry) R&D portfolio, through deep engagement in discovery and seamless transition between discovery/ preclinical into early clinical research
- To lead Translational Strategy Teams consisting of other Research and Clinical scientists to develop a Translational Research Plan, including design and oversight of preclinical and translational studies that will best inform clinical development
- To lead matrixed platform functions in development of biomarkers and execution of Experimental Medicine studies to establish human models that will accelerate quantitative, disciplined Go/NoGo decisions earlier in development, based on biomarker-driven Early Proof-of-Concept studies
- To develop and drive the Translational Research Plan as part of the overall Asset Strategy in the Global Project Team
- This role embraces the principles of a translational/exploratory mindset, with a focus on operational excellence, and deep scientific rigor
- Acts as a key interface between the Neuroscience Drug Discovery Unit scientists and Therapeutic Area Unit clinicians to ensure portfolio prioritization and seamless transition of programs between research and clinical development
- Translational Medicine lead on the Global Project Team, leading development of the Translational Medicine strategy as part of the overall Asset Strategy
- Drive projects to rigorous assessments of therapeutic success or failure by testing clear scientific hypotheses as early, leanly, directly, and quickly as possible in the preclinical, translational, and experimental medicine stages of development
- Engages early (at lead optimization stage) with Neuroscience Drug Discovery Unit to assist in research portfolio prioritization, based in part on translation strategy
- Provides Translational Medicine expertise and recommendations to Drug Discovery Unit on Go/No-Go decisions at candidate decision gates
- Leads the Translational Strategy Team of the Global Project Team to support fluid/tissue biomarker, imaging, neurocircuitry biomarker (electrophysiology), and/or pharmacogenomic strategies and implementation
- Creates the Translational Research Plan, integrating input from other functions as needed, including Basic Research, Translational Biomarker Research, Imaging, Neurocircuitry Biomarkers, Quantitative Clinical Pharmacology, Clinical Operations, and Clinical Science
- Engages the Neuroscience Therapeutic Area Unit clinicians during TRP creation to ensure Translational Medicine studies support decision-making for late phase development.
- Designs and implements clinical protocols for Experimental Medicine studies to test novel biomarkers and study designs in order to support earlier decision-making in development
- Contributes to authorship, review and approval of other key documents, including investigator brochures and INDs/CTAs as needed as well as co-authored publications in scientific journals
- Ensures agile, timely management of issues arising from ongoing studies, including serving as the study physician for adverse event reporting
- Works closely with Clinical Operations, Procurement, and Legal functions to support clinical study implementation of Experimental Medicine studies
- Provides Translational Medicine expertise for external opportunities, including participation in due diligence teams
EDUCATION, BEHAVIORAL COMPETENCIES, AND KNOWLEDGE/SKILLS:
- MD, MD/PhD preferred
- Formal clinical training, including fellowship training with Neuroscience specialization, preferably Neurology in the areas of Movement Disorders or Neuromuscular Disease
- Clinical development and/or translational/ experimental medicine expertise strongly preferred
- Clinical development experience should be in academia and/or industry, including early clinical trial design and implementation, documentation / filing.
- Discovery/basic research experience is preferred
- Academic clinical experience is preferred
- Rigorous record of scientific publication is required
- Minimum 3-10 years biopharmaceutical/CRO health-related consulting company/academic industry early clinical development experience
- Distinctive ability to engage in discourse on innovative drug discovery from early preclinical through to late-stage development
- Driving results is essential. Need to be able to motivate individuals in a cross-functional, matrixed organization and project team setting, to achieve and exceed goals by establishing accountabilities, clarifying performance expectations, agreeing to high standards and measures, monitoring and reviewing performance, and providing timely and relevant feedback.
- Demonstrated strategic thinker with an ability to create and drive a shared understanding of a long-term vision.
- Planning, priority-setting, and time management are essential.
- Accountability - takes responsibility for his or her own performance and accepts full ownership of issues, problems, and opportunities, regardless of the source.
- Comfort with ambiguity is required.
- Demonstrated creativity and innovation, including ability for divergent thinking and the propensity to question to traditional methods, processes, and products, as well as build on others' ideas.
- Excellent communication, interpersonal sensitivity, and negotiating skills
- Team-work, partnership and collaboration skills
- Neuroscience-related clinical expertise
- Basic and clinical science of neuroscience pathophysiology
- Translational medicine, including biomarkers
- Nonclinical and clinical drug discovery and development
- Regional/Global Regulatory requirements
EDUCATION, LICENSES, CERTIFICATIONS:
- Medical degree required
- MD-PhD preferred
- Board certification preferred
Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually
Bonus Payment: Twice a year
Working Hours: 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Refresh Leave, Maternity Leave, Childcare Leave, Family Nursing Leave, Philanthropy Leave.
Flexible Work Styles: Flextime, Telework
Real Staffingについてもっと詳しく知りたい方はこちらへ→ www.apac.realstaffing.com/ja