Sr. Director, Clinical Operations

Taiho Oncology, Inc.•Pleasanton, CA

1d•Hybrid

About The Position

Taiho Oncology is seeking a Sr. Director, Clinical Operations to lead and oversee all aspects of Global Clinical Operations for assigned Taiho Oncology (TOI) Development Programs. This role involves supervising the planning and execution of clinical trials and programs within established timelines, quality standards, and budget, while ensuring adherence to regulatory requirements and company SOPs. The Senior Director will also oversee the implementation of all clinical trial activities using both internal and external resources. The company emphasizes a "People first" approach, valuing employees and fostering a culture of accountability, collaboration, and trust. Taiho Oncology is dedicated to improving the lives of patients with cancer through cutting-edge science and a growing portfolio and pipeline.

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.
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.
Support business development if needed.