Associate / Senior Clinical Trial Management Associate, Clinical Operations

NGM Bio

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 03/31/2021
  • Website: ngmbio.com
  • Company Address: 630 Gateway Blvd, South San Francisco, CA, 94080-7014

About NGM Bio

NGM Bio is a research-driven, clinical-stage biopharmaceutical company with a passion to improve the lives of those struggling with serious diseases. Our expertise in drug discovery and translational development, coupled with the significant resources from our partnership with Merck, is driving development of transformational medicines that dramatically improve human health.

Job Description

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 Senior 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 NGM’s trials in a variety of therapeutic areas.  The successful candidate must have good business acumen and some background in oncology, liver and/or metabolic diseases, or ophthalmology, and who has demonstrated well-rounded experiences in clinical trial execution, preferably from study start-up to trial initiation, maintenance and closure. 
 
The CTMA / SCTMA will be part of the integral team to support clinical development programs, provide support with timelines, budgets, planning, and implementation of clinical trials, and coordinate communications with vendors and sites.  NGM values team players who are comfortable working with a shared resource pool and operating in a nimble, fast-paced environment.

Responsibilities:

    • Ensures that NGM’s 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 NGM 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 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 oncology or other clinical trials
    • Works closely with relevant cross-functional team members to support clinical trial activities
    • Participates in review of study-related outputs such as tables, figures, listings, clinical study reports, and publications, as appropriate

Knowledge, Experience, and Skills Required:

    • BS required; Postgraduate level degree (MS/PhD) preferred
    • CTMA - 3+ years of clinical operations / drug development experience in pharma / biotech
    • SCTMA - 5+ years of clinical operations / drug development experience in pharma / biotech
    • Demonstrated understanding of scientific methodology and applications for 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 NGM 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 should have demonstrated clinical development experience and proficiency in liver diseases or metabolic diseases, ophthalmology, or oncology
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 apply through the NGM Biopharmaceuticals website: https://www.ngmbio.com/open-positions/
 
We have become aware of false offers of employment being made by individuals impersonating NGM representatives in order to collect personal information and/or payment. Please exercise caution when receiving unsolicited recruiting offers. NGM always lists all open positions on the NGM careers page and all employment applications must be submitted through our online portal. NGM will never solicit payment or payment information from candidates. Please be advised that NGM is not currently hiring in any countries other than the US. We never request that candidate information be sent to a non-ngmbio.com email address.  
 
Note to Recruitment Agencies: Please do not forward any agency résumés. NGM Bio is not responsible for any fees related to résumés that are unsolicited.   

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This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.