Senior Director, Clinical Operations (autoimmune)

United States·San DiegoFull-Timesenior

OtherClinical Operations

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Overview

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.

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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. This role is responsible for efficient planning, resourcing and execution of portfolio level programs in adherence to ICH-GCP, FDA regulations, and company SOPs. The Senior Director will report into the Vice President, Clinical Operations and will ensure strategic alignment of programs and key stakeholder management in a fast-paced environment, while mentoring and growing the Clinical Operations team and culture to ensure successful program delivery.

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.

Bachelor’s degree in life sciences or related field with 12+ years of experience in clinical research, including at least 10 years in clinical trial management. Advanced degree preferred.

Strong experience in complex autoimmune indications, early phase experience strongly preferred.

Ability to define strategy and ensure organizational goals are executed in global clinical operations plans.

Proven track record of leading complex clinical programs from start to completion.

Strong knowledge of ICH GCP, FDA regulations, and global clinical regulatory guidelines.

Strong IT skills in MS Office and clinical trial systems (e.g., CTMS, eTMF, EDC).

Expertise in clinical budgeting and efficient allocation of resources

Demonstrated success in leading, mentoring, developing diverse clinical teams and providing oversight to CROs.

Excellent communication, leadership, and interpersonal skills, including the ability to understand and present technical information effectively to executive leadership.

Strong organizational and time management abilities.

High level of accountability, adaptability, and attention to detail with an ability to set priorities and handle multiple tasks simultaneously in a changing environment.

Ability to work independently and collaboratively in a fast-paced, matrixed environment.