Sr. Director, Clinical Operations

Taiho Oncology, Inc.•Pleasanton, CA

1d•Hybrid

About The Position

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. 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 clinical operation team, provide leadership to clinical studies and programs and experience multiple facets of Clinical Operations in a dynamic, supportive, collaborative, and global cross-functional environment. The incumbent will lead and oversee all aspects of Global Clinical Operations for the assigned Taiho Oncology (TOI) Development Programs. This responsibility includes supervising the successful planning and consistent execution of TOI sponsored clinical trials and programs within timelines, quality standards and budget. This individual is also accountable for adherence to relevant regulatory requirements and company SOPs. Finally, the Senior Director, Clinical Operations will oversee implementation of all clinical trial activities utilizing both internal and external resources.

Requirements

BA/BS in life sciences, scientific or other related discipline or equivalent experience.
Ten (10) or more years’ experience in a pharmaceutical, biotechnology, CRO or academic research environment leading consistent global clinical trials execution, preferably oncology trials.
Minimum of 5 years of direct supervisory experience required.
Experience leading phase 1-3 global studies and clinical development programs.
Experience in directing, leading, motivating and developing team members within a global clinical environment in Oncology.
Demonstrated leadership skills and the ability to develop, manage and mentor staff members.
Proven record of developing and maintaining relationships with external partners and CROs.
Significant experience in contract negotiation, management and clinical finance activities.
Sound judgment and reasoning skills to define problems, collect and analyze data, establish facts and recommend a course of action.
In depth knowledge of GCP and ICH guidelines as well as understanding of US and global regulations and guidelines (i.e. FDA, EMA) applicable to clinical development.
Excellence in written and oral communication.
Ability to work independently and collaboratively in a fast-paced team environment.

Nice To Haves

Advanced degree preferred.

Responsibilities

Develops the clinical operations strategy for global clinical development to ensure clinical trials are properly defined, planned and executed. This includes scenario planning to support program level teams to ensure study designs and clinical development plan are operationally feasible.
Ensures CRO vendors are selected and managed to deliver high quality clinical studies within established timelines and budget.
Supervises study managers, and clinical operations personnel.
Accountable for development, training and retention of the clinical operations team; ensures activity prioritization and clinical operations resourcing (both internal and external) is aligned with development program needs.
Direct the development of high quality/harmonized study management plans/tools that include enrollment milestones, risk identification/mitigation strategies, financial oversight, communication requirements, etc.
Accountable for direction, implementation, execution and monitoring of all clinical trials, including site feasibility, site selection/initiation, data quality, site close out and relevant activities through database lock.
Develops, implements and executes consistent training for Taiho studies/programs with internal and external teams including investigative sites.
Responsible for preparation of and management of clinical operations budget within company thresholds, for all Taiho Oncology sponsored clinical trials.
Drives the development and maintenance of SOPs/Work Instructions, systems and processes for the Clinical Operations organization at Taiho Oncology.
Builds collaborative cross functional relationships with key internal stakeholders including Development teams, Project Management, QA, Regulatory Affairs, Biostatistics/DM, Clinical Supplies and Finance as required to support development programs.
Fosters highly collaborative culture and serves as leadership role model within the company and with external partners.
Lead by example and foster a culture of sharing lessons learned.
Serves as a point of escalation for study team within assigned program and for direct reports.
Represent Clinical Operations on various Joint Operational Committees with CROs and Partners and collaborate closely to resolve issues, mitigate risks and track studies KPIs and progress.
Reports key milestone and studies progress to Sr. Management. Attend and present in governance meetings to drive decisions.
Collaborate closely with TPC key program leads.
Seek continuous improvement of the quality of clinical operations deliverables and effective use of applicable technologies within the department.
Responsible for ensuring Taiho programs and clinical operations activities both internally and externally are conducted according to GCP, ICH, and other applicable regulations.
In collaboration with the VP of Clinical Operations, provide input to resource management and drive department’s and company’s goals.
Some travel is required.
Support business development if needed.