Sr. Director, Clinical Operations
About the role
Taiho Oncology is seeking a Senior Director, Clinical Operations to lead and oversee all aspects of Global Clinical Operations for the assigned Taiho Oncology (TOI) Development Programs. This role involves supervising the successful planning and consistent execution of TOI-sponsored clinical trials and programs within timelines, quality standards, and budget.
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.
Directs the development of high-quality/harmonized study management plans/tools that include enrollment milestones, risk identification/mitigation strategies, financial oversight, communication requirements, etc.
Oversees the development, 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.
Prepares and manages 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 a highly collaborative culture and serves as a 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.
Represents Clinical Operations on various Joint Operational Committees with CROs and partners and collaborates closely to resolve issues, mitigate risks, and track studies KPIs and progress.
Reports key milestone and studies progress to Sr. Management.
Attends and presents in governance meetings to drive decisions.
Collaborates closely with TPC key program leads.
Seeks 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, provides input to resource management and drives department's and company's goals.
Requirements
BA/BS in life sciences, scientific or other related discipline or equivalent experience. Advanced degree preferred.
Minimum of 10 years of 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.
Qualifications
Education/Certification Requirements: BA/BS in life sciences, scientific or other related discipline or equivalent experience. Advanced degree preferred.
Skills and Abilities
Knowledge of GCP and ICH guidelines as well as understanding of US and global regulations and guidelines (i.e. FDA, EMA).
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.
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.
Excellence in written and oral communication.
Ability to work independently and collaboratively in a fast-paced team environment.
Pay
The pay range for this position at commencement of employment is expected to be between $250,750 - $295,000 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, 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.