Director of Bioanalytical Group

Location
South San Francisco, CA
Posted
Nov 08, 2018
Ref
212-181
Required Education
Doctorate/PHD/MD
Position Type
Full time

JOB DESCRIPTION

NGM Biopharmaceuticals, Inc. is a private 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 six drug candidates in various stages of development, including NGM282 that recently demonstrated proof-of-concept in a Phase 2 study in non-alcoholic steatohepatitis (NASH). We have many more in preclinical development. In 2015, we entered into a broad, strategic collaboration with Merck that will provide us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.  

Recognized expert in the overall strategy and planning; and in design, execution and interpretation of Pharmacokinetic, Pharmacodynamic and Immunogenicity assays and related bioanalytical techniques. Experience with potency assays and biomarker assays is a plus. As Head of Bioanalytical Group reporting to the Senior VP of Biologics and CMC. Directs research, non-clinical and clinical bioanalytical activities; assigns and monitors projects and reviews protocols and reports generated by the group and CROs. Understands corporate goals and timelines and assumes responsibility to ensure they are met. Work extensively with CROs to manage our outsourced GLP bioanalytical assays and ensure quality. An acknowledged leader within the bioanalytical community with excellent communication skills who serves as a resource for scientific and technical questions by senior management. Contributes to the Project Development Team strategy as the key representative for the Bioanalytical Group and serves as an industry opinion leader in bioanalysis and immunogencity community.

REQUIRED SKILLS

  • Provides opinion and suggestions to the Executive Team with regard to the strategy and planning of the Bioanalytical work at the company. Be responsible for the design, execution and interpretation of bioanalytical assays. Scientific expert who contributes to responses to questions from regulatory agency on bioanalytical assays and immunogenicity. This may be achieved by collaborating with different disciplines and across cross functional teams.
  • Be very experienced in Managing CROs extensively and effectively to outsource our GLP bioanalytical assays for non-clinical and clinical bioanalytical work.
  • Makes significant contributions to multidisciplinary, bioanalytical, regulatory and clinical team meetings.
  • Directs and develops effective teams that are highly productive and work in an appropriately compliant environment to generate reliable and reproducible data under aggressive timelines.
  • Develops direct reports; establishes goals and provides periodic performance feedback including conducting formal performance appraisals. Creates an environment which stimulates, develops, and promotes the scientific and career development of direct/indirect reports.
  • Projects company leadership in bioanalytical assays and immunogenicity by interacting with industry opinion leaders and representatives from various regulatory agencies at prominent conferences. Participates on industry teams that formulate the policy and guidelines that impact bioanalysis and immunogenicity. Generates and contributes to industry position papers and white papers.
  • Builds strong relationships and networks externally as well as internally with development area leaders, facilitating strategic alignment and collaborations with partners.
  • Leader in building groups/teams and delivering strategies that empower and grow the group through mutual trust and enhanced technical competencies. Constructs and leads highly motivated teams by directing, mentoring, and creating an environment for collaborative research.
  • Maintains accurate and complete safety records consistent with company policy and legal requirements. Recognizes potential safety problems and takes action to rectify them.

REQUIRED EXPERIENCE

  • PhD
  • 15+ years in the biopharmaceutical industry
  • 10+ years leading a bioanalytical team

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"