Hybrid Employee Value Proposition:At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to lead global clinical trials and experience multiple facets of Clinical Development in a dynamic, supportive, collaborative, and global cross-functional environment.
Position Summary:This position has direct responsibility for design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3.
Performance Objectives:- Assumes the medical leadership on clinical trials for Taiho Oncology, Inc. (TOI) in the USA and Europe.
- This position serves as a 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 and signs off on 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 or the Chief Medical Officer.
- Keeps SVP Clinical Development or the Chief Medical Officer current on status of clinical trials and provides ongoing risk assessments for the study conduct and operational risks.
- Co-responsible with SVP 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.
Education/Certification Requirements:- Successful completion of MD training mandatory; completion of training in a medical sub-specialty with a completed fellowship in a Hematology-Oncology program preferred.
- Hematology or Oncology Board eligibility or certification preferred.
- Clinical practice experience of a minimum of 1-3 years preferred.
Knowledge, Skills, and Abilities:- 4-7 years combined experience in academic and/or industry oncology clinical research and drug development, including experience as medical monitor or investigator on a clinical oncology trial.
- 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.
- Working knowledge of the drug development process in the USA and EU is required
- Experience in direct interactions with US and/or EU Regulatory authorities is highly preferred.
- 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.
The pay range for this position at commencement of employment is expected to be between $323,850-$381,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.
If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#Location-Princeton,NJ #LI-HybridThe incumbent in this position may be required to perform other duties, as assigned. 
