Associate Director, Scientist Clinical Development

Job Locations US-NJ-Princeton
Regular Full-Time

Position Summary

Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy.  This position has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3.


  • This position serves in assisting the responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, as needed.
  • Uses medical/scientific expertise to create or support the creation of relevant clinical   documents of high quality such as study concepts, study protocols and reports, investigator   brochures, NDA/MAA registration documents and publications.
  • Reviews clinical documents related to clinical studies as outlined by the manager.
  • Builds and maintains effective relationships with clinical key opinion leaders in various   different areas of disease in which Taiho is developing drugs.
  • Will collaborate with all department heads within TOI (Head of Clinical Research and Head of Clinical Operations) to establish operational plans and timelines for respective studies within each of the development programs for review by the SVP Clinical Development
  • Keeps SVP/VP Clinical Development current on status of clinical trials and provides ongoing risk assessments for the study conduct and operational risks.
  • Co-responsible with SVP/VP Clinical Development, Project Management, Head of Clinical Research, and Head of Clinical Operations for delivering the design, conduct, and reporting of clinical trials within agreed timelines.
  • Collaborates with Clinical Operations/trial management in vendor oversight.
  • Continually assesses if adequate resources are available to meet clinical trial deliverables and milestones.
  • Performs other duties as required


Educational Requirements:  

  • PhD, PharmD or other related Advanced Medical Scientific Degree


  • 2-5 years combined experience in academic and/or industry oncology clinical research and drug development.
  • Experience in oncology a plus
  • At least 2 years in drug development industry in oncology and with previous exposure to  clinical development, regulatory and statistical activities such as, e.g., (co-)authoring and reviewing of documents such as clinical trial protocols, statistical analysis plans, IND AR,NDA AR, PSUR, DSUR, IB, ICF, orphan drug designations, regulatory briefing document, etc. is preferable.
  • Ability to critically review and interpret Clinical data

Other Skills and Abilities:

  • Working knowledge of the drug development process in the USA and EU is required
  • Highly detail and quality oriented.
  • Excellent presentation skills.
  • Ability to learn, integrate complex information, and communicate clinical information in easily   understandable fashion to non-clinical team members.
  • Ability to understand and implement prioritization of deliverables as well as recognize and   highlight conflicts in priorities
  • A positive attitude, flexibility and a proactive thought process

Language Skills:

  • Ability to read, analyze and interpret scientific and technical information and data.
  • Excellent English communication skills, both verbal and written

Mathematical Skills:

  • Ability to work with mathematical concepts such as probability and statistical measures

Reasoning Ability:

  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical information and deal with several abstract   and concrete variables

Computer Skills:

  • Strong computer skills in MS Office products

Physical Demands:

  • While performing the duties of this job, the employee is frequently required to sit, talk and hear.
  • The employee is occasionally required to walk.
  • Must be able to travel domestically and internationally on a reasonably frequent basis -approx. 15-20% of time including some weekend travel
  • Domestic and international travel includes spending time at cancer trial sites/institutions,conference centers, offices and hotels

Work Environment:

  • The noise level in the work environment is usually quiet.


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



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