Job Description

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• 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.

REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES

• 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.