Position Details

Position Information

Recruitment/Posting Title
Assoc. Dir Research Operations (Operations Manager/Scientist)

Job Category
Staff & Executive - Executive

Department
Clinical & Translational R

Posting Summary

Rutgers, The State University of New Jersey is seeking an Associate Director Research Operations (Operations Manager/Scientist) within the Rutgers Contract Research Collaboratory (RC)2 Division of the Rutgers Institute for Translational Medicine and Science (RITMS).

The Associate Director, Research Operations will serve as a strategic partner to the Director in establishing, growing, and continuously improving the Rutgers Contract Research Collaboratory (RC)2. This individual will provide scientific, operational, and regulatory leadership across a diverse portfolio of industry-sponsored, federally funded, and investigator-initiated clinical research programs, translating sponsor clinical development objectives into high-quality, compliant, and efficiently executed studies.

Working collaboratively with investigators, sponsors, institutional leadership, and multidisciplinary research teams, the Associate Director will oversee portfolio planning, study feasibility, operational strategy, resource allocation, staffing, budget development, vendor management, and performance monitoring. The successful candidate will help develop standardized operating procedures, quality management systems, and operational metrics that promote efficiency, consistency, regulatory compliance, and continuous process improvement across the organization.

The Associate Director will play a central role in sponsor engagement and business development by supporting proposal development, protocol feasibility assessments, and strategic partnerships while ensuring studies are delivered on time, within budget, and to the highest scientific and regulatory standards. The position requires extensive knowledge of FDA regulations, ICH-Good Clinical Practice (ICH-GCP), IND and IDE studies, and the regulatory requirements governing multi-site clinical research.

As a member of the (RC)2 leadership team, the Associate Director will recruit, mentor, and develop high-performing staff while fostering a collaborative, inclusive, and accountable culture focused on innovation, professional development, and exceptional customer service. The individual will work closely with project management, clinical data management, biostatistics, regulatory affairs, and scientific leadership to build an integrated Clinical and Data Coordinating Center capable of supporting complex national and international clinical research programs. As a founding leader of (RC)2, the Associate Director will have a unique opportunity to shape the center's strategic direction, operational infrastructure, and organizational culture while contributing to Rutgers Health's vision of becoming a national leader in clinical research coordination and translational science.

Essential Duties and Responsibilities include the following:

• Serves as a senior sponsor-facing representative of the Rutgers Contract Research Collaboratory, supporting sponsor engagement, needs assessments, proposal development, scope-of-work development, budget strategies, bid-defense preparation and implementation, sponsor governance meetings, and identification of repeat or add-on opportunities.
• Oversees Rutgers Contract Research Collaboratory portfolio-level planning and execution in collaboration with the Director, including prioritization of studies, staffing models, workload distribution, operating budgets, vendor decisions, financial performance, and escalation of major scientific, operational, regulatory, or financial risks.
• Leads cross-functional project teams and governance discussions across sponsors, Rutgers stakeholders, investigators, vendors, and operational staff.
• Provides scientific and regulatory strategy support for industry-sponsored drug and device studies, including studies conducted under IND and IDE frameworks; advise sponsors and Rutgers teams on protocol gaps, execution risks, and practical options to improve study quality and feasibility.
• Drafts, critically review, or oversee scientific, operational, and regulatory documents, which may include protocols, synopses, project bids, informed consent templates, study manuals, clinical study reports, regulatory responses, sponsor presentations, standard operating procedures, and other study-specific materials.
• Partners with sponsors, investigators, regulatory experts, biostatistics, data management, clinical operations, and quality teams to ensure that study design and execution plans are aligned with applicable FDA, ICH GCP, institutional, and international requirements
• Oversees the development, implementation, and continuous improvement of the Rutgers Contract Research Collaboratory's clinical research quality system, including SOP architecture, controlled documents, training expectations, audit/inspection readiness, issue escalation, CAPA processes, and risk-based quality management.
• Provides strategic oversight and management to Clinical Study Managers and other operational staff responsible for study start-up, activation, site feasibility, IRB/regulatory submissions, vendor coordination, study conduct, and closeout.
• Responsible for the hiring, firing, performance review and training of the research staff.

FLSA
Exempt

Grade
35S

Salary Details

Minimum Salary
134982.000

Mid Range Salary
170754.000

Maximum Salary
206525.000

Offer Information

The final salary offer may be determined by several factors, including, but not limited to, the candidate's qualifications, experience, and expertise, and availability of department or grant funds to support the position. We also take into consideration market benchmarks, if and when appropriate, and internal equity to ensure fair compensation relative to the university's broader compensation structure. We are committed to offering competitive and flexible compensation packages to attract and retain top talent.

Benefits

Rutgers provides a comprehensive benefits package to eligible employees. The specific benefits vary based on the position and may include:

• Medical, prescription drug, and dental coverage
• Paid vacation, holidays, and various leave programs
• Competitive retirement benefits, including defined contribution plans and voluntary tax-deferred savings options
• Employee and dependent educational benefits (when applicable)
• Life insurance coverage
• Employee discount programs

Position Status
Full Time

Working Hours

Standard Hours
37.50

Daily Work Shift

Work Arrangement

Consistent with the current application of Rutgers Policy 60.3.22 or the applicable provisions of relevant collective negotiations agreements, this position may be eligible for a hybrid work arrangement. Flexible work arrangements are not permanent, subject to change or discontinuation, and contingent on the employee receiving approval in the FlexWork@RU Application System.

Union Description
MPSC - Legacy UMD

Payroll Designation
PeopleSoft

Seniority Unit

Terms of Appointment
Staff - 12 month

Position Pension Eligibility
ABP

Qualifications

Minimum Education and Experience

• Advanced degree (PhD, PharmD, MD, or master's degree) in a relevant scientific discipline.
• Minimum 10 years' clinical research experience within a regulatory agency (e.g., FDA), in the pharmaceutical, biotechnology, or CRO industry. Alternatively, academic clinical research experience with some industry/CRO experience.
• Two (2) years of relevant supervisory experience.
• Hands-on experience supporting regulated industry-sponsored clinical trials, including drug and/or device studies conducted under IND and/or IDE frameworks.

Certifications/Licenses

Required Knowledge, Skills, and Abilities

• Strong knowledge of ICH and US regulatory requirements (IND, IDE, NDA, etc.).
• Familiarity with CRO business processes, including sponsor intake, feasibility assessment, proposal development, scopes of work, clinical trial budgets, change-order concepts, and bid-defense preparation.
• Demonstrated ability to draft and review scientific documents, including protocols and study reports.
• Excellent scientific writing, presentation, negotiation, document reviews, and executive communication skills.
• Strong organizational skills with the ability to manage multiple projects and priorities.
• High attention to detail and commitment to quality.
• Ability to lead in a complex matrixed academic medical center environment while maintaining a sponsor-focused, service-oriented, high-accountability operating model.

Preferred Qualifications

• Experience designing or scaling clinical research infrastructure, including SOP development, quality systems, staffing models, service lines, metrics, and portfolio governance.
• Experience preparing for or supporting sponsor audits, internal audits, FDA inspections, EMA or other health authority inspections, CAPAs, and inspection-readiness programs.
• Global clinical research experience and familiarity with international regulatory expectations.
• Deep understanding of ICH GCP, FDA, and international regulatory guidelines.

Equipment Utilized

Physical Demands and Work Environment

PHYSICAL DEMANDS:

• Standing, sitting, walking, speaking and hearing.
• No special vision requirements.

WORK ENVIRONMENT:

• Office environment. Moderate noise.

Special Conditions

Posting Details

Posting Number
26ST1540

Posting Open Date

Special Instructions to Applicants

Regional Campus
Rutgers Biomedical and Health Sciences (RBHS)

Home Location Campus
Downtown New Brunswick

City
New Brunswick

State
NJ

Location Details

Pre-employment Screenings

All offers of employment are contingent upon successful completion of all pre-employment screenings.

Immunization Requirements
Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Additional infection control and safety policies may apply. Prospective employees should speak with their hiring manager to determine which policies apply to the role or position for which they are applying. Failure to provide proof of vaccination for any required vaccines or obtain a medical or religious exemption from the University will result in rescission of a candidate's offer of employment or disciplinary action up to and including termination.