- Job Type: Full-Time
- Function: Clinical Research
- Industry: Biotechnology
- Post Date: 08/01/2022
- Website: ngmbio.com
- Company Address: 333 Oyster Point Blvd, South San Francisco, CA, 94080
About NGM BioNGM Biopharmaceuticals is a privately-held drug discovery company committed to identifying transformational medicines that dramatically improve human health. Based on emerging human clinical and genetic observations, the company has devised several innovative experimental approaches to discover new therapies for the treatment of metabolic andcardiovascular diseases.
NGM Biopharmaceuticals, Inc., a biotechnology company focused on discovering and developing novel, life-changing medicines for people whose health and lives have been disrupted by disease, is a leader in the emerging area of immuno-oncology R&D known as myeloid checkpoint inhibition. We have built a comprehensive myeloid reprogramming and checkpoint inhibition portfolio with three disclosed product candidates targeting four receptors – ILT2, ILT3, ILT4 and LAIR1 – engineered to reprogram myeloid cells to reverse the suppression of immune responses to tumor cells. In addition, we are developing an antagonist antibody designed to inhibit GFRAL discovered as a result of our research into metabolism and autonomic nervous system regulation of the immune system. These product candidates are the fruits of our biology-centric drug discovery approach, which aims to seamlessly integrate interrogation of complex disease-associated biology and protein engineering expertise to unlock proprietary insights that are leveraged to generate promising product candidates and enable their rapid advancement into proof-of-concept studies. As explorers on the frontier of life-changing science, we aspire to operate one of the most productive research and development engines in the biopharmaceutical industry and our research team has a track record of producing an average of one new IND candidate per year. Today the company has seven disclosed programs, including four in Phase 2 or 2b studies, across three therapeutic areas: cancer, retinal diseases, and liver and metabolic diseases.
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 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.
- Ensures that NGM’s clinical trials are properly executed within budget and scope 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, listings, figures, clinical study reports, and publications, as appropriate
Knowledge, Experience, and Skills Required
- BS required; Postgraduate level degree (MS/PhD) preferred
- SCTMA – minimum of 3 years of clinical operations experience in 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
- 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 oncology, liver / metabolic diseases, or ophthalmology