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13125BR

Title:

Associate Director, Clinical Research (U.S. Remote)

Job Description:

Lead the strategic planning and operational execution of clinical trials within the neurovascular therapeutic area. Responsible for driving clinical program success through effective study management, team leadership, and strong cross-functional collaboration with Medical Affairs, PACE, Regulatory, Clinical Safety, and Data Management. Ensure high standards of patient safety, data quality, and regulatory compliance while supporting the development and growth of the clinical research team. Job duties:

Operational Leadership

+ Lead and manage Clinical Operations teams to ensure effective study execution, protocol compliance, timelines, and budget adherence.

+ Oversee clinical site management activities including selection, initiation, monitoring, and close-out with strong regulatory and GCP compliance.

+ Collaborate with Medical Affairs, Clinical Quality Assurance, Clinical Data Management and Clinical Safety functions to maintain data integrity and timely safety reporting.

+ Identify and resolve operational challenges proactively to ensure project success.

Strategic Support & Collaboration

+ Assist in developing and implementing clinical trial strategies aligned with business priorities.

+ Act as a key liaison between Clinical Operations and departments such as Regulatory Affairs, Quality, R&D, PACE, R&D, and Medical Affairs to ensure alignment and smooth communication.

+ Manage vendor relationships and CRO oversight to meet quality standards and timelines.

People Management & Team Development

+ Supervise, mentor, and develop Clinical Operations staff to build a high-performing and engaged team.

+ Drive performance management, goal setting, and professional growth initiatives within the team.

+ Foster a culture of collaboration, accountability, and continuous improvement.

Project Management

+ Develop and monitor project plans, resource allocation, and budgets for clinical trials.

+ Provide regular status updates to senior leadership and escalate risks appropriately.

+ Facilitate effective cross-functional team meetings and communication.

Compliance & Quality Assurance

+ Ensure compliance with applicable regulatory requirements, company policies, and SOPs2. Prepare for and support audits and inspections; lead corrective and preventive actions as needed.

+ Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.

+ Perform additional duties as assigned.

Salary Range:

$158,000 - $195,000 Financial compensation packages may be higher/lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demands,

Auto req ID:

13125BR

Location MV:

Aliso Viejo, California, USA

Department Name:

652-Clinical Admin-Pre Market Operations

Qualifications:

1. Bachelor of Science degree in a related field of study.

2. Minimum ten (10) years of professional experience in clinical research, including a minimum of eight (8) years of experience supporting neurovascular clinical trials.

3. Minimum three (3) years of management or leadership experience.

4. Proficient in Clinical eSystem platforms and Microsoft Office Suite, including Word, Excel, Outlook, and Teams.

5. Demonstrated ability to lead cross-functional teams and provide updates to senior stakeholders.

6. Proven experience with audits and regulatory inspections.

7. Strong written and verbal communication skills.

Desired Qualifications

1. Master’s degree in Life Sciences or equivalent combination of education, training, and experience.

2. Minimum five (5) years of hands-on experience in clinical trial design and strategic execution and oversight across programs from start to finish.

3. Strong knowledge of clinical trial processes and both U.S. and international (OUS) regulatory requirements.

4. Excellent organizational, analytical, and decision-making skills.

5. Experience with literature reviews, historical data analysis, and statistical interpretation.

6. PMP or equivalent project management certification.

7. Experience with full product lifecycle management.

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

External-Facing Title:

Associate Director, Clinical Research (U.S. Remote)

Posting Country:

US - United States

Salary Range:

$158,000 - $195,000 Financial compensation packages may be higher/lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.