Director, Clinical Research Scientist

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, we are dedicated to transforming the landscape of cancer treatment and improving patients' lives. As a Director, Clinical Research Scientist, you will play a pivotal role in our mission, leveraging your expertise to drive innovative clinical research and contribute to groundbreaking therapies. We offer a collaborative and inclusive work environment where your ideas and contributions are valued. Join us to advance your career, work with passionate and skilled professionals, and make a meaningful impact on the fight against cancer. At Taiho Oncology, you will find purpose, growth, and the opportunity to be at the forefront of cancer research.

Position Summary:


The Director, Clinical Research Scientist has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3. Additionally, this role serves in assisting the responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, and assisting the Clinical Research Scientist Manager to contribute to CRS process improvement, as needed.

Performance Objectives:

• Uses medical/scientific expertise to support the creation of relevant clinical documents of high quality such as study concepts, study protocols, amendments, study reports and investigator brochures.
• At the asset level, assists the medical lead in the preparations of the clinical content of regulatory submissions/documents (e. g. NDA, MAA, IND, CTA. sNDA, DSUR, PIP, health authority/ethics committee responses, briefing packages).
• Works with the medical lead to prepare presentations (internal and external), abstracts, manuscripts.
• Inputs into the of ICF/reviews ICF.
• Works with data management on CRF design and completion guide.
• Partners with data management to develop data review plan for review of data and with medical lead for the medical monitoring plan.
• Reviews protocol deviations, patient eligibility, and patient level and cumulative data per the data review plan across a study, raises queries and coordinates with the medical lead.
• Reviews safety data with the medical lead, SAE reports (in collaboration with pharmacovigilance), labs, efficacy data, dosing data, withdrawals/discontinuations.
• Collaborates with the medical lead to provide medical/scientific guidance during the execution of the study.
• Ensures TMF compliance for clinical development/medical study level TMF documents.
• Answers specific site protocol questions as needed, after consultation with the medical lead.
• Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, vendor / CRO staff, in collaboration with the medical lead.
• Escalates protocol-related issues requiring complex medical expertise to the medical lead, and operational issues to the appropriate operations study team member.
• Reviews the SAP and statistical outputs, in collaboration with the statistician, medical writer, and medical lead.
• Reviews the CSR (interim; final; addendum), in collaboration with the medical writer and medical lead and/or any related publications (abstracts; presentations at meetings or publications in scientific journals) in relation with medical writer and medical lead.
• Assist in any other asset activities requiring clinical/ scientific expertise.

Education/Certification Requirements:

• PhD, PharmD or other related Advanced Medical Scientific Degree.
• Experience in oncology is a must.

Knowledge, Skills, and Abilities:

• At least 5 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.
• Ability to critically review and interpret Clinical data.
• Working knowledge of the drug development process in the USA and EU is required.
• Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members.
• Ability to follow independently delegated activity linked to clinical research scientist function, communicate progress and understand timelines

The pay range for this position at commencement of employment is expected to be between $238k - $280k 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.


#Location-Princeton,NJ #Location-Pleasanton, CA #LI-Hybrid Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email [email protected] . Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

The incumbent in this position may be required to perform other duties, as assigned.