Senior Clinical Trial Manager, Clinical Operations
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.
NGM Bio’s Clinical Operations group is growing to support our rapidly progressing clinical programs, and we are seeking a Senior Clinical Trial Manager to join a high-performance team. Qualified candidates direct and oversee operations of one or more clinical trials, including timelines, budgets, cross-functional logistics and resources. The Sr CTM will manage external contract research organizations and functional service providers, liaise with sites and investigators, and may eventually assume management responsibility for internal Clinical Operations staff. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate with the highest of ethical standards and professionalism is essential in this role.
Responsibilities of role:
- Actively provides direction and oversight of clinical trials
- Leads CRO and critical vendor selection process for outsourced activities, including development of scope of services agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met
- Supports the forecast and management of project/program budgets, including long range forecasting of clinical trial costs
- Develops and executes operational plans
- Provide technical expertise for the development of clinical documents (protocol, informed consent form, CRF, monitoring plans, regulatory submission documents, clinical study report, investigator brochures, etc.)
- Identifies clinical program/resource gaps and performs project risk analyses, and implements solutions
- Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations
- Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
- May support development of clinical operations quality systems, including standard operating procedures, document management, personnel training, and quality control processes
- May support development of department goals and objectives
- May manage and mentor clinical team members
- May manage Clinical Operations personnel directly
- BS required / MS, PharmD, or PhD or equivalent in a scientific discipline is preferred
- Minimum of 7 years of clinical operations experience with thorough understanding of cross functional clinical processes including clinical supply, data management, biostatistics, and medical writing
- Strong working knowledge in Good Clinical Practices and ICH Guideline and the application to the conduct of clinical trials
- Experience in US and Ex-US clinical study management and regulatory processes
- Vendor (CRO, site) and personnel management experiences
- Proven ability to provide highly organized and detail focused oversight to the execution of clinical studies
- Ability to succeed in fast paced organization
- Demonstrated self-starter and team player with strong interpersonal skills
- Strong leadership skills; Excellent written and verbal skills required
- Experience in one of our core disease states (hepatology, metabolic, ophthalmology, and immuno-oncology)
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.
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