The Senior Director of Clinical Operations will provide global operational leadership overseeing complex clinical programs focusing on innovative T-cell engager therapies for immunology indications.
Requirements
- Drive global clinical operations strategy and execution for programs ensuring all clinical activities support IND-enabling -Phase 3 objectives, as well as future clinical development plans.
- Collaborate effectively cross-functionally with senior leadership to ensure operational initiatives support strategic company goals.
- Establish and refine scalable best practices to drive efficiency while preparing for future departmental growth.
- Oversee the development, review, and operational implementation of study documents, including protocols, informed consent forms, CRFs, monitoring plans, and pharmacy manuals ensuring consistency among programs.
- Responsible for successful external partner relationships including CROs, central labs, patient advocacy groups and others. Ensure deliverables are met on time, within budget, and to quality standards.
- Prepare and deliver program updates, establish KPIs and dashboards, and effectively present to all study teams. Strongly represent Clinical Operations in internal and external meetings.
- Mentor and support direct reports, fostering professional development, team performance and a strong culture.
- Oversee site strategy and establish Clinical Operations team relationships with investigators and key opinion leaders.
- Contribute to the development and implementation of SOPs, work instructions, and operational plans to enhance team efficiency and compliance.
- Develop and implement operational plans, timelines, and budgets for clinical programs.
- Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.
Benefits
- Annual bonus program
- Incentive stock option plan
- 401k plan with flat non-elective employer contribution
- Comprehensive medical insurance with 90-100% employer-paid premiums
- Dental and vision insurance
- HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
- Unlimited PTO
- Generous holiday schedule; includes summer and winter company shutdown
- Relocation assistance
