Associate Director, Director - Clinical Pharmacology
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 seven 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.
• Contributes broadly with accountability for all clinical pharmacology strategy for NGM product development teams (PDTs)
• Provide clinical pharmacology representation to PDTs; authors and reviews documents, including clinical protocols, analysis plans, study reports and global regulatory submissions, including: INDs, IBs, BLAs, MAAs and pediatric plans
• Actively leads in the planning of clinical study design with regard to collection of clinical pharmacokinetic data and associated endpoints
• Interpret clinical pharmacokinetic data as it relates to PKPD analysis and modeling to better inform dose and dose regimen for early and late stage clinical development (Phase 1 to Phase 3)
• Closely work with and guide preclinical pharmacokinetic scientists to inform human dose projections and estimation of efficacious dose and exposure range in humans
• Provide mentorship and guidance to junior scientists with potential supervisory role
• PhD and/or Pharm D degree in pharmaceutics, pharmacokinetics, pharmacology, or related discipline
• Minimum 5 to 8 years experience in the biotech/pharmaceutical industry in the area of clinical drug development
• Experience in supporting the clinical pharmacology function to advance programs from early to late phase clinical develop and NDA/BLA filing
• Experience with large molecule (proteins and monoclonal antibody) pharmacokinetics
• Strong understanding of bioanalytical assays development and qualification (PK and ADA) for large molecules (protein and monoclonal antibody).
• Must be detail oriented with strong documentation and organizational and management skills
• Excellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholders.
• Excellent communication and presentation skills to efficiently relay information to project teams, external partners and other key stakeholders
• Strong research background and interest in understanding PK data in the context of complex biology
• Proven ability to work independently and be self-motivated
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"