Description

With support from the internal team, you will be assisting with all legal startup activities as it relates to late-stage clinical trials, which will include, but not limited to contracting, ICF review, amendments, liaison to CRO, clinical and development operations, regulatory affairs, and finance.

Responsibilities

• Manage and maintain the lifecycle of the contract process to ensure workflows occur in a timely manner for all clinical contracting activies.
• Negotiate clinical trial agreements, master service agreements, scope of works and related budgets in accordance with established timelines and budget.
• Host weekly/monthly meetings with internal and external teams to ensure all activities are progressing in an orderly manner.
• Partner closely with clinical operations, project leadership, CRO and management and additional functional leaders to understand the trials or study priorities to support timely delivery of negotiated contracts and budgets.
• With support and oversight, drives the development of key documents including Clinical Trial Agreement (CTA) templates, Confidentiality Agreements (CDAs), negotiation parameters, in collaboration with the clinical operations, finance, and other departments as necessary.
• Independently manages Contract Research Organizations (CRO) with respect to CDA/CTA/budget negotiations; sets clear milestones, escalation steps, and triggers.
• Contributes to vendor selection and Request for Proposal (RFP) process including participation in vendor bid defenses and negotiation of vendor contracts/budgets.
• Buildout technical infrastructure to support clinical studies in an efficient and effective manner.
• Some knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• BS/BA in business, law or science required with a minimum of 5-7 years’ experience including 3 years prior experience in a biotech/pharma company or university setting. JD/MBA preferred.
• Knowledge of principals related to negotiating with Academic and Non-Profit institutions such as Hospitals.
• Knowledge of the current global and regional trends in clinical outsourcing and contracting as well as legal and regulatory environment as it relates to the pharmaceutical/biotech industry.
• Knowledge of the drug development process with a deep understanding of the operational aspects of clinical development including a thorough knowledge of the clinical site contracting process.
• Strong interpersonal skills to maintain positive working relationship with internal and external stakeholders.
• Detail-oriented mindset with excellent verbal and written communication skills.

• Local candidates preferred as this is a hybrid role, with 3 days in the office expectation (South San Francisco).
• Pliant will not offer relocation asistance for this position.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $135,000 - $150,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.