Posted in Science 29 days ago.
Type: Full-Time
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:
Taiho Oncology is a Japanese company specializing in the development and commercialization of orally administered anti-cancer agents. Our mission is to improve the lives of patients with cancer, their families, and their caregivers. Whether it’s our patients or employees, people come first at Taiho. 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. Our culture is inclusive and our leadership ensures an environment which encourages employees to be accountable for their own successes. We hold ourselves and each other to a high bar of executional excellence because patients are counting on us. Collaboration and trust are additional core principles operating at Taiho which sets us apart from other organizations. These principles foster open communication and fun atmosphere. Respect, dignity, compassion and kindness are required of each of employee. We believe that honesty and integrity are critical to our business and our actions earn each other’s trust and the trust of the community we serve. For this position, the incumbent will be assigned to lead one or two high priority late-phase clinical development programs as Global Regulatory Lead (GRL), responsible for leading regulatory sub-team and all regulatory activities including marketing authorization filing and approval in US and Europe.
Position Summary:
The incumbent is the most senior regulatory person on project teams and is responsible for regulatory activities globally except for Japan and Asia. For assigned projects and products, the Senior Director, Regulatory Affairs Strategy is responsible for strategic definition/direction, and implementation of regulatory strategies, and ensures that these strategies are consistent with company objectives. The incumbent directs the project/product teams’ regulatory activities to ensure high quality, regulatory integrity, and completeness of all projects. The incumbent is responsible for providing guidance and directing all regulatory activities during drug development, approval and post approval process and for commercialization, in coordination with both internal staff and external consultants and contractors.
Performance Objectives:
Education/Certification Requirements:
Knowledge, Skills, and Abilities:
The pay range for this position at commencement of employment is expected to be between $240 and $283k 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 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.
#Pleasanton, CA
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