Description

With support from the internal team, you will be responsible for 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. Furthermore, you will be working closely to develop and support junior Legal team members as well as strategizing on how to grow and shape Pliant’s Legal Team.   

Responsibilities

• The successful candidate will be responsible for the development, negotiation, review, and lifecycle management of contracts supporting Pliant’s development and clinical projects. On an as needed basis, they will also assist with SRA and MTA with Academic and Non-Profit Institutions.
• This includes direct negotiation and oversight of the negotiation of clinical trial agreements, master service agreements, and scope of work agreements and related budgets in accordance with established timelines and budget.
• 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.
• Creates and 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.
• Provides direct oversight of 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.
• Develop and implement legal process to support several late-stage clinical studies.
• Review of Informed Consent Form (ICF) templates
• Working 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 or science required with a minimum of 5-7 years’ experience including prior experience negotiating clinical development contracts in a biotech/pharma company or university setting. JD/MBA preferred.
• Extensive experience negotiating with Academic and Non-Profit institutions such as Hospitals.
• Demonstrable 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.
• Ability to work independently while managing to multiple priorities.
• Knowledge of Data Privacy Regulations/Laws (e.g., GDPR, HIPAA & PIPEDA).