Clinical Research Associate/Senior Clinical Research Associate, Clinical Operations - Liver Disease
NGM Biopharmaceuticals, Inc. is a biopharmaceutical company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases. Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to build a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine that has a track record of generating one new IND candidate per year. NGM’s current pipeline of clinical-stage programs consists of five drug candidates targeting liver and metabolic diseases, retinal diseases and cancer. The most advanced drug candidate, aldafermin (NGM282), is in Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH) and is wholly-owned by NGM. Another drug candidate, NGM621, is in a Phase 2 study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). NGM’s strategic collaboration with Merck, with a current term running to March 2022, provides us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
Reporting to the Director of Clinical Operations, this position is responsible for assisting all aspects of the clinical development activities and interfacing with vendors and investigators to optimize program efficiency across each of NGM’s trials in NASH and other liver diseases, as appropriate. The successful candidate must have a good business acumen and some background in liver and/or metabolic diseases who has demonstrated well-rounded experiences in clinical trial execution, preferably from study start-up, trial initiation, maintenance and closure.
NGM values team players who are comfortable working with a shared resource pool and operating in a nimble, fast-paced environment.
The CRA / SCRA, Clinical Operations – Liver Disease will be part of the integral team to support the NGM282 (aldafermin) clinical development program, providing supports in timelines, budgets, planning and implementation of clinical trials and communications with vendors and sites.
- Ensures that NGM282 clinical trials are properly executed within budget and in accordance with established timelines and quality standards
- Provides support in all aspects of clinical trial from tracking of enrollment status, accruing of study activities, reviewing of study documents (eg, protocol, ICF, education materials, CRF, monitoring reports, study plans), participating in team meetings, and study close-out activities
- Assists in NGM282 (aldafermin) CRO and vendor selection process for outsourced activities, including routing and review of services agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met
- Helps identify and report any NGM282 (aldafermin) clinical program/resource gaps and helps devise project risk analyses, and implements solutions
- Follows clinical operations quality systems, including standard operating procedures, document management and quality control processes to support NGM282 (aldafermin) clinical trials
- Works closely with relevant cross-functional team members to support NGM282 (aldafermin) clinical trial activities
- Participates in review of study-related outputs such as tables, figures, listings, clinical study reports, and publications, as appropriate
- BS required / Postgraduate level degree (MS/PhD) preferred
- At least 3 years of clinical operations/drug development experience in pharmaceutical/biotech organization(s); NASH experience preferred
- Demonstrated understanding of scientific methodology and applications within clinical development
- Must be comfortable in assessing complex problems and synthesizing solutions based on evolving datasets and information
- Possess excellent communication skills to represent department internally and company externally
- Basic knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus
- Candidates who have not had background in liver diseases should have demonstrated clinical development experience and proficiency in metabolic diseases
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, 401(k), ESPP and a comprehensive benefits package.
Interested applicants should click "Apply"
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