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Machine Operator 2nd Shift

NGM Biopharmaceuticals

Machine Operator 2nd Shift

South San Francisco, CA
Paid
  • Responsibilities

    NGM Biopharmaceuticals, Inc. is a clinical stage biotech 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 form a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine. To date, NGM Bio has generated a pipeline of seven drug candidates in various stages of development targeting liver, metabolic and ophthalmic diseases and cancer. The most advanced drug candidate, NGM282, is entering Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH). NGM’s strategic collaboration with Merck, which was extended to March 2022, will continue to provide us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.

    We are recruiting an experienced medical director with a background to join our growing clinical development organization. The ideal candidate is a strategic thinker who will help implement clinical development strategy for one or more of NGMs assets by leveraging a thorough understanding of disease landscape, unmet clinical need, competitive landscape and other salient factors. The director/senior director will act as the internal medical and scientific expert on relevant programs. The director/senior director will work 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. We seek an individual who is a fast learner and will enjoy working in more than one therapeutic area.

    Required Skills

    • Function as medical expert on one or more NGM clinical development programs
    • 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 opinion leaders
    • Serve as medical monitor on relevant clinical trials

    Required Experience

    • MD or relevant experience (including academia)

    • At least 5 years of clinical development experience in a biopharmaceutical company including involvement with clinical development planning, clinical trial, design, execution and analysis

    • Candidates who are not specialty trained should have demonstrated clinical development experience and proficiency in ophthalmology

    • Accredited residency training and board-certification/eligibility in ophthalmology. Candidates who are ophthalmologists should have experience in and a desire to work in other areas.

    • At least 3 years of clinical development experience that includes clinical development planning, clinical trial design and execution, regulatory filings and exposure to commercial and payer aspects of drug development

    • 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

    • 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

    • Ability to influence and drive a cross functional team

    • Experience with NDA/BLA highly desirable

    • Willingness to travel

    • Ability to represent the program and engage external business partners /KOLs /regulatory bodies

    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 apply through the NGM Biopharmaceuticals website: http://www.ngmbio.com/careers/#SilkroadFrame

  • Qualifications
    • Function as medical expert on one or more NGM clinical development programs
    • 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 opinion leaders
    • Serve as medical monitor on relevant clinical trials