Clinical Site Liaison (Contract)

THE COMPANY

89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco.

THE ROLE

We are a growing organization dedicated to advancing clinical operations through strategic site engagement. Our team is passionate about optimizing site relationships to ensure the success of clinical trials. We are looking for a Clinical Site Liaison to support our clinical operations team in facilitating seamless site interactions. Reporting into the Associate Director, Clinical Operations, the successful candidate will have clinical trial operational experience and deep understanding of patient pathways and trial recruitment. Proven expertise in playing a key supports by coordinating, scheduling, engaging, building and maintaining excellent working relationships with country/region specific investigative sites, KOLs, site networks and Patient Advocacy groups (PAG). From within the Clinical Operations (Clin Ops) team, closely work together with the clinical trial/ indication teams and with CROs and other vendors. Collaborate with the 89bio Clinical Development group (CD) group, as well as, with the Medical Affairs group (MSLs).

SPECIAL ADVISORY 

The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, please Report any Scams. 

THE RESPONSIBILITIES 

• Interface and act as a local 89bio TrialOps representative, an expert on liason and SME providing the 89bio teams/sites with knowledge and awareness about the current clinical trials
• Proactively work to fully understand all matters that impact the successful patient recruitment and high-quality conduct of the clinical trial at each site, eg the Principal Investigator (PI) and site preferences and best practices on clinical trials, standard of care treatments, competing studies etc. Ensure a supportive relationship with clinical sites and trial personnel
• Proactively work to fully understand the patient voice, preferences and pathway(s). Closely work with the argenx GPA team. Speak to patient groups and support groups, live events and conferences as allowed by local / regional guidance. May also attend live and virtual patient events to assist in responding to questions about 89bio, the trial(s) and other information on Mechanism of Action (MOA)
• Closely work together with the MAS, CD, CO colleagues, eg the MSLs to ensure optimal synergies in the respective site contacts and support
• Optimize site engagement for a specific trial and across the MASH program to ensure site engagement and quality for the site-level enrollment and execution of every trial
• Oversee and track patient recruitment for the regional sites and pro-actively identify ways to prevent recruitment delays
• Pro-actively identify issues and look for solutions in the assigned site engagement process and timely escalate them to the respective study MSLs, Clinical Study Lead, CTM and/or Senior Management, as needed
• Identify efficiencies, best practices and lessons learnt and ensure they are shared across trials/indications/compounds
• Search for and embrace innovation
• Participate in workstreams and provide input to procedures/SOPs/ WIs and related
• Coordinate and schedule site engagement visits and calls by liaising with clinical sites and internal team members.
• Provide relevant site metrics and background information to prepare team members for engagement activities.
• Assist in generating and finalizing site contact reports, ensuring accuracy and completeness.
• Maintain and update tracking systems for site engagements.
• Serve as a primary point of contact for scheduling logistics and follow-ups.
• Support additional administrative tasks related to site engagement as needed.

THE QUALIFICATIONS 

• Bachelor’s degree, Scientific or health related field University degree – medical or para-medical (MD, Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
• Minimum of 6 years of experience in Biotech / pharma / healthcare preferably in roles including site engagement and / or clinical trial monitoring experience or administrative support within healthcare or life sciences is preferred.
• Strong organizational skills with the ability to manage multiple tasks and deadlines.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Excellent communication and presentation skills and relationship management of multiple stakeholders, internally and externally, including sites, KOLs, networks, advocacy groups, CROs and others
• Leadership with the ability to overcome challenges, seek opportunities to remove barriers, influence without authority
• Highly developed organizational skills, problem solving, analytic and able to prioritize
• Experience with tools and systems for managing clinical studies
• Ability to work effectively in an onsite, team-oriented environment.

SALARY & LEVEL

89bio considers a range of factors when determining the salary and level. These considerations mean actual salary and level may vary. The salary range for this position in Northern California is $90/hour - $100/hour and will be commensurate with experience.

89bio’s role/level assessment approach involves assessing candidates during the interview process before confirming the level/title designation. The level assessment is considered on a case-by-case basis. Offer and level is based on factors such as: education, experience, qualifications, geographic location, transferable skills, licenses/certifications and other job-related factors permitted by law. 

CONDITIONS OF EMPLOYMENT 

• Background investigations are required for all positions by 89bio, consistent with applicable law. 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. 

89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bio will ensure that persons with disabilities are provided reasonable accommodations for the hiring process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship. 

Notice to Recruiters: To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team. 

Salary : $90 - $100