Head of NASH/Metabolic Diseases

Location
South San Francisco, CA
Posted
Jan 14, 2021
Required Education
Doctorate/PHD/MD
Position Type
Full time

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 CMO, this position is responsible for the strategic clinical oversight of the NASH and metabolic portfolio.  The successful candidate has an accomplished background in liver and/or metabolic diseases and is a strategic thinker who has late stage experience to lead from development through commercialization.  The VP, Head of NASH/Metabolic Diseases will have significant accountability for NGM’s portfolio of NASH programs and is responsible for the design, implementation and execution of the clinical development strategy and associated studies.  

Responsibilities

  • Lead the strategic and clinical oversight of the NASH portfolio of development programs
  • Deliver clinical development plans enabling regulatory submissions and approvals
  • Serve as medical expert on NGM clinical development programs in liver and metabolic diseases
  • Internal medical and scientific expert working closely with internal project team leaders and relevant cross-functional team members to use emerging data and information to build, revise or update development strategy when appropriate. Provide medical and scientific expertise into clinical development and protocol planning activities
  • Serve as expert medical and scientific point of contact for regulatory and ethics committee interactions
  • Plan and participate in data analyses and creation of key study-related outputs such as clinical study reports and publications
  • Develop and maintain relationships with external stakeholders such as key advisors, academic institutions, regulators and investigators
  • Serve as medical monitor on relevant clinical trials

Required Experience

  • M.D. or M.D./Ph.D. with board certification/eligibility in hepatology, gastroenterology or endocrinology preferred
  • At least 10 years clinical drug development experience in pharmaceutical/biotech organization(s); NASH experience preferred; we will consider Sr Director through VP candidates, and level will be commensurate with experience
  • Experienced at filing products with global regulatory world health authorities (IND, BLA, and NDA)
  • Demonstrated understanding of scientific methodology and applications within clinical development
  • Demonstrated understanding of clinical development planning in a holistic environment that includes scientific, regulatory, commercial and reimbursement aspects
  • Must be comfortable in assessing complex problems and synthesizing solutions based on evolving datasets and information
  • Possess excellent communication skills with presence to represent company externally
  • Demonstrated expertise in clinical trial design, execution and analysis
  • Demonstrated expertise in efficacy and safety data interpretation and communication
  • Basic understanding of biostatistics methodology
  • Ability to effectively communicate complex scientific concepts to broader audience
  • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus
  • Direct management experience of at 5 years 

Preferred Qualifications

  • Candidates who are not specialty trained should have demonstrated clinical development experience and proficiency in liver diseases
  • Phase 3 experience preferred
  • Accredited residency training and board-certification/eligibility 

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.

Interested applicants should click "Apply"

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