Senior Clinical Trial Manager, Oncology / Immuno-oncology
Employment Type: Full-Time
NGM Biopharmaceuticals, Inc. is a leader in research elucidating the central role that myeloid cells play in creating a suppressive environment around many solid tumors that restricts antitumor immunity. Through systematic screening, NGM was able to identify the suppressive receptors that are most highly enriched in myeloid cells. An additional strength of our research group is the design and construction of highly potent antibodies and other biologics. Pairing these capabilities with the identification of these suppressive receptors on tumor-associate myeloid cells has produced a promising pipeline of new medicines aimed at treating solid tumors. Three oncology molecules produced from this approach include NGM707 (anti-ILT2/ILT4 dual acting antibody), NGM831 (anti-ILT3), NGM438 (anti-LAIR1). In addition, NGM120 (anti-GFRAL) emanates from our metabolic research and autonomic nervous system regulation of the immune system.
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 cancer, retinal diseases, and liver and metabolic diseases. These programs include MK-3655 in a phase 2b clinical study in patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis stage 2 or 3 (F2/3), being run by our partner, Merck, aldafermin in a Phase 2b clinical study in NASH patients with F4 liver fibrosis and compensated cirrhosis, NGM621 in a Phase 2 study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD), NGM120 in a Phase 2 study for the treatment of metastatic pancreatic cancer, and NGM707 in a Phase 1/2 study for the treatment of advanced solid tumors.
Reporting to the Senior Director of Clinical Operations, this position will be responsible for the operational direction and oversight of clinical studies, including timelines, budgets, cross-functional logistics and resources, as well as management of external contract organizations and functional services providers. The Sr CTM may be assigned to leading studies associated with a single molecule or may be assigned to studies associated with multiple molecules. The successful candidate must have good business acumen and some background in oncology, immuno-oncology, and/or metabolic diseases; someone who has demonstrated well-rounded experiences in clinical trial execution, preferably from study start-up to trial initiation, maintenance and closure.
* 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.
* Supports development of clinical operations quality systems, including standard operating procedures, document management, personnel training, and quality control processes
* BS required / MS, PharmD, or equivalent in a scientific discipline is preferred
* Minimum of 8 years of industry clinical operations experience with thorough understanding of cross functional clinical processes including clinical supply, data management, biostatistics, and medical writing
* Oncology / immuno-oncology experience required
* Strong working knowledge in Good Clinical Practices and ICH Guideline and the application to the conduct of clinical trials
* Experience in both US and Ex-ES clinical study management
* Direct and in-direct management experience
* 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
* Excellent written and verbal skills required
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, employee stock purchase program participation, 401(k) and a comprehensive, industry-leading, benefits package.