Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission : to improve the lives of patients with cancer, their families, and caregivers.
Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission.
Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust.
By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other.
Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients.
Advanced technology, a world-class clinical development organization, and state-of-the-art facilities : these and other resources empower us to innovate and touch the lives of more and more patients.
It’s our work, our passion, and our legacy.
We invite you to join us. 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 leading global development program(s), including strategy, design, oversight, and analysis of Phase 1-4 oncology clinical trials.
This position will be the medical point of contact for all aspects of studies within the program(s) and accountable for program deliverables. Performance Objectives :
Medical global lead for development program(s)Provide oversight for global Phase I-III and “ancillary” trials as Lead medical monitor for global development program(s)Use medical / scientific expertise and strategic thinking to develop clinical development plans (incl.study design and companion diagnostics)
Take accountability for strategy and deliverables of assigned global development program(s)Medical point of contact for all clinical questions related to the development program.Perform data review supported by Clinical Research Scientist(s) (CRS), participate in protocol deviation meeting that will occur monthly or as needed.Create or support the creation of relevant clinical documents of high quality, such as study protocol protocol(s), investigator brochure (IB), informed consent forms (ICF), case report forms (CRF), Clinical study report (CSR), NDA / MAA registration documents, and scientific publications.Analyze and interpret outcome of clinical studies within the global development program(s)Answer medical questions raised by Regulatory Agencies (RA) and Institutional Review Boards / Ethics Committees (IRBs / ECs) relevant to the studies within the global development program(s).Collaborate with all department heads within TOI (e.g., Head of Clinical, Medical Operations and Project Management, or functional equivalents) to establish operational plans and timelines for respective programs / studies for which he / she will be co-responsibleBuild and maintain effective relationships with clinical key opinion leaders in areas of disease relevant for the assigned global development program(s)Provide strategic input to preclinical studies in collaboration with Research Teams in Japan.Supervise Medical Monitors or CRS(s) as required.Keep management current on status of development program(s) and provides ongoing risk assessments for the study conduct and operational risks.Represent the molecule at senior management governance meetings.
Mentoring and training of junior staff in Clinical Development and other departments as required.Perform other duties as required. Education / Certification Requirements :Successful completion of MD training mandatory; ≥3 years of clinical experience in treating oncology patients or a completed fellowship in a Hematology-Oncology program.Hematology or Oncology Board eligibility or certification preferred. Knowledge, Skills, and Abilities :Strong working knowledge of the US / EU drug development process required.8 years of combined experience in oncology clinical research and drug development in academic and / or industry, including experience as a medical monitor and (sub)investigator in oncology clinical trials.3 years in industry leadership as medical lead for an oncology development program(s) with direct or indirect management of cross-functional areas (e.g., clinical operations, biostatistics, data management, biomarker, pharmacovigilance, quality, etc.)Knowledge in authoring key clinical development documents (e.g., study protocol, IB, ICF, CRF, CSR, DSUR, PBRER, and documents for regulatory interactions).Ability to learn, integrate complex information, and manage competing priorities for program deliverablesExcellent presentation skills and communicate clinical information in easily understood manner to non-clinical team membersAbility to persuade and negotiate with program team members and senior management.Positive attitude, flexibility, and proactive thinking.Track record of scientific publications in peer reviewed journals strongly preferredWilling to travel domestically and internationally.The incumbent in this position may be required to perform other duties, as assigned. The pay range for this position at commencement of employment is expected to be between $336,000– $396,000 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, meijob-related knowledge, skills, and experience.
The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, commissions, 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 an 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 #Location-Pleasanton,CA #LI-Hybrid
Salary : $336,000 - $396,000
