Assistant Director, Clinical Trials Contracts

University of California; Los Angeles (CA); On-site; USD 128,500 - 298,100; Full time

Job summary

The UCLA Clinical and Translational Science Institute (CTSI) is seeking an Assistant Director, Clinical Trials Contracts to provide strategic leadership for the Clinical Trials Contracts & Strategic Relations unit within the Office of Clinical Research.

Reporting to the Director, this role oversees the negotiation, execution, and administration of complex industry-sponsored clinical trial agreements while ensuring efficient, compliant, and high-quality pre-award contracting operations.

Qualifications

• Bachelor’s Degree required.
• At least 10 years negotiating industry-sponsored trials; 3 years management experience.
• Expertise in industry clinical trial agreement drafting and negotiation.
• Knowledge of pre-award activities (IRB, CIRC, Coverage Analysis, etc.).
• Knowledge of FDA and other regulatory requirements for drug/device trials.
• Experience collaborating with faculty, sponsors and research administration.
• Strong communication, leadership and decision-making skills.

Responsibilities

• Negotiate, execute, and administer complex industry-sponsored trial agreements.
• Provide strategic leadership for the Contracts & Strategic Relations unit.
• Supervise, mentor, and manage daily operations of contract professionals.
• Collaborate with faculty, sponsors, and research administration stakeholders.
• Drive process improvements, policy development, and performance metrics.

Skills

Contract negotiation

Contract management

Leadership

Regulatory knowledge

Communication

Project management

Stakeholder engagement

Team supervision

Legal drafting

Clinical research operations

Education

Bachelor’s Degree

Graduate degree (JD/MPH/MBA)

Job description

Salary Range: $128,500 - $298,100 Annually

Primary Duties and Responsibilities

The UCLA Clinical and Translational Science Institute (CTSI) is seeking an Assistant Director, Clinical Trials Contracts to provide strategic leadership for the Clinical Trials Contracts & Strategic Relations unit within the Office of Clinical Research. Reporting to the Director, this role oversees the negotiation, execution, and administration of complex industry-sponsored clinical trial agreements while ensuring efficient, compliant, and high-quality pre-award contracting operations. The Assistant Director supervises and mentors a team of contract professionals, manages daily operations and workflow, and partners with faculty, sponsors, and research administration stakeholders to support timely study start-up. This position also plays a key role in advancing operational excellence through process improvement initiatives, policy and procedure development, performance metrics, and strategic planning in support of UCLA's clinical research enterprise.

Job Qualifications

Required:

• Bachelor’s Degree.
• At least 10 years recent experience negotiating industry supported clinical trials, 3 years management experience.
• Demonstrated expertise in industry clinical trial agreement drafting and negotiation.
• Strong working knowledge of the full range of pre-award activities related to clinical trials research (e.g.,IRB, CIRC, Coverage Analysis, other regulatory approvals, etc.)
• Knowledge of pharmaceutical, biomedical, and/or medical device company research and development trends.
• Demonstrated mature clinical and independent administrative judgment and decision-making skills.
• Experience working with faculty, administrators, and staff in an academic medical center, health care or university environment.
• Knowledge of research regulatory requirements (including FDA and other federal and state regulations), GCP/ICH guidelines, and special requirements for drug and medical device trials.
• Demonstrated knowledge of industry contracting and subcontracting practices, including demonstrated experience in drafting contracts and subcontracts.
• Demonstrated excellence in negotiating skills, including the ability to resolve conflict among various groups and individuals with diverse backgrounds and goals concerning sensitive and important issues. Proven ability to participate effectively in the planning and development of multidisciplinary, cross-departmental research programs and committees.
• Ability to communicate effectively regarding the health sciences campus research process and related details to a wide audience (scientists, physicians, nurses, staff, sponsors, and the general public.)
• Ability to design and manage efficient work processes, set and meet expected turnaround time goals on an ongoing basis and monitor, analyze, and improve processes on an ongoing basis.
• Ability to be flexible and adapt within an ever-changing, dynamic, service-oriented environment.
• Ability to operate effectively in a team environment.
• Ability to set priorities of assignments to complete work in a timely manner when there are changes in workload, pressures of deadlines, competing requirements and changes in assignments.
• Ability to establish and maintain cooperative and mutually supportive working relationships with faculty, administrators, staff, other campus units, UC system units, and sponsoring agencies and companies.
• 18. Skill in analyzing information, problems, situations, policies or procedures to define the problem, need or objective, identify relevant issues or concerns, formulate alternatives for resolution or new program development, and recommend alternative choices and implications for implementation.
• Excellent written and verbal communications skills.
• Familiarity with UCLA Medical Center (preferred) or similar organization computing systems and demonstrated ability to learn and utilize other databases and administrative software, including a future clinical trials information system.

Preferred:

• Graduate degree – Juris Doctorate, Paralegal Degree with focus in contract management, or Master in Public Health or Master of Business Administration.

As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer. Current/former UC employees are subject to a personnel file review.