Research Administration Clinical Contracts Officer (Clinical Trials + Manufacturing and Service Agreements)
School of Medicine, Stanford, California, United States
New
Compliance Legal
Post Date 8 hours ago
Requisition # 108879
This position is located within Research Administration and not within Office of General.
Stanford University is seeking a Research Administration Clinical Operations Contracts Counsel (with an equal split between Clinical Trial Agreements and Manufacturing + Service Agreements) to independently draft, negotiate and administer non-disclosure agreements, clinical trial agreements, service agreements, manufacturing agreements, quality agreements, collaborations, and material transfer agreements. Hold delegated signing authority for agreements on behalf of the university.
The Research Administration Clinical Operations Contracts Counsel is a non-General Counsel role within the Stanford School of Medicine's Research Management Group (RMG), providing strategic oversight for one of the nation's most complex and research-intensive academic medical environments.
This position and the ideal candidate will have responsibility for handling contract drafting, negotiation, and finalization in support of industry sponsored, and investigator initiated clinical trial agreements, related non-disclosure agreements, subcontract agreements, subaward agreements, material transfer agreements, and other auxiliary agreements in support of the clinical research conducted by Stanford faculty.
Additionally, as part of RMG's contract team, the ideal candidate will have the ability and skill set to crossover and provide contract drafting, negotiation, and finalization for non-research related agreements, such as Service Agreements, Manufacturing and Supply Agreements, Quality Agreements, and other related agreements (such as Technology Transfer Agreements). The candidate's prior experience with manufacturing/supply agreements and corresponding quality agreements includes contract drafting for the production of products such as radiopharmaceuticals, radiotracers, and/or cell-therapies/CAR-Ts. Collectively, the ideal candidate will have knowledge and expertise in multiple aspects of clinical, pharmaceutical, and medical device development, including knowledge and a background in the Code of Federal Regulations and supportive guidance documents, cGMP, privacy laws, quality assurance, and compliance with institutional policies.
The Contracts position plays a pivotal role in strengthening the School of Medicine's clinical operations contracting arm by supporting shared standards of excellence across different aspects of clinical contracting services, standardizing and improving processes, and ensuring a cohesive, faculty-centered service model. The role is well suited for dynamic contract professionals who has the ability to downshift from different @types of agreements (from clinical, to service agreements, to manufacturing), responding to questions and inquiries, address related contract compliance matters, and engage in process improvement projects within RMG.
The candidate will have had prior experience handling contracts and compliance matters at a large academic medical institution, in addition to some prior history or engagement with similar work in the pharmaceutical industry, medical device industry, contract manufacturers, and/or contacting arms supporting non-profits engaged in medical research.
Duties include*:
Conduct formal negotiations, finalize and administer industry sponsored project agreements, commensurate with experience.
Negotiate intellectual property and publication rights, as well as confidentiality, indemnification and invoicing terms.
Negotiate complex Clinical Trial Agreements and related Subaward Agreements and Subcontract Agreements, Manufacturing Supply Agreements and related Quality Agreements, and Service Agreements that complies with University, Federal and other regulatory policies, requirements and conditions.
Negotiate other research-related agreements that involve intellectual property, publication and confidentiality issues.
Identify contractual and policy issues such as compliance, conflicts of interest and accounting, provide follow through until resolved.
Advise and assist study teams and faculty by interpreting and explaining contract terms and conditions of applicable agreements.
Assist in resolving contractual problems that arise during course of project by consulting with investigators, staff and sponsors.
Review and revise standard agreements to reflect changes in University policies, Federal regulations and laws.
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- Other duties may also be assigned.
DESIRED QUALIFICATIONS:
Law degree or equivalent, with prior experience drafting, negotiating, and finalizing contracts in support of clinical trials, clinical operations, industry-sponsored research, and service agreements within a large academic research institution and/or the pharmaceutical or medical device industry.
Ability to draft, negotiate, and conclude clinical trial agreements, industry-sponsored research agreements, and service agreements.
Strong understanding of intellectual property and licensing considerations as they relate to industry-sponsored clinical trials, clinical research activities, and associated service agreements.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and five years of relevant experience or a combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Demonstrated ability to draft, negotiate and conclude industry research agreements.
Demonstrated understanding of intellectual property and licensing issues as they pertain to industry sponsored research.
Demonstrated understanding of university research environment and policies.
Advanced communication skills to clearly and effectively communicate information to internal and external audiences, client groups and all levels of management.
Strong analytical and problem solving skills to review and analyze complex information.
Strong service orientation, demonstrated ability to work effectively in a fast-paced, action-oriented, customer-focused service environment.
Extremely detail oriented and able to work well independently, but also able to seek out assistance when needed.
Excellent interpersonal skills, good judgment and the ability to conduct negotiations in a timely manner.
Strong organizational skills and the ability to prioritize a variety of tasks and demands.
Strong computer skills, including Microsoft Office Suite and ability to learn applicable university and departmental systems.
CERTIFICATIONS & LICENSES:
State bar licensure is a benefit, but not required.
PHYSICAL REQUIREMENTS*:
Frequently perform desk based computer tasks, seated work and use light/ fine grasping.
Occasionally stand, walk, use a telephone, lift, carry, push, and pull objects that weigh up to 10 pounds.
Rarely writes by hand.
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- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
WORK STANDARDS:
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide,http://adminguide.stanford.edu.
This role is open to candidates anywhere in the United States. Stanford University has five Regional Pay Structures ( https://drive.google.com/file/d/1ulfJcCeFgFqGOQk4lHik3MIU8aKGi28p/view ).
The compensation for this position will be based on the location of the successful candidate. The expected pay range for this position is $69,518 to $119,710 per annum. Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the university reasonably expects to pay for a position upon hire. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.
At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website ( https://cardinalatwork.stanford.edu/benefits-rewards ) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.
Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form _.
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned._
Additional Information
Schedule: Full-time
Job Code: 4507
Employee Status: Regular
Grade: I
Requisition ID: 108879
Work Arrangement : Remote Eligible
