Senior Director, Clinical Operations

About the role

The Senior Director of Clinical Operations will provide global operational leadership overseeing complex clinical programs focusing on innovative T-cell engager therapies for immunology and oncology 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.

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.

Requirements

Essential 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.

Qualifications

Qualifications:

• Experience in complex autoimmune indications, early phase experience strongly preferred.
• 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.

Skills

Skills:

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

Benefits

Annual bonus program
Incentive stock option plan
401(k) 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