Medical Director - Oncology

Location
South San Francisco, CA
Posted
Dec 07, 2018
Ref
1848U
Required Education
Doctorate/PHD/MD
Position Type
Full time

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).  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.

We are recruiting a talented physician scientist with significant experience in advancing clinical development programs from first-in-human through proof-of-concept studies in oncology indications.  The medical director will have the opportunity to lead cross-functional product development teams seeking to translate NGM’s scientific discoveries into transformational medicines for cancer patients.  The successful 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 the novel pathways and underlying biology, disease landscape, unmet clinical need and other salient factors. The director/senior director will lead the design, execution, monitoring, analysis and reporting of clinical studies for our growing portfolio of cancer and immune-oncology programs.  In addition, the physician scientist will serve as the primary point of contact for communicating with external oncology leaders, clinical investigators and academic groups.  The medical director will work closely with research scientists and translational research in order to design efficient clinical programs that address whether the novel biology identified by NGM’s teams can address significant unmet need for cancer patients.

Responsibilities

  • Participates in and/or serves as the leader of one or more of NGM’s cross-functional product development teams
  • Responsible for clinical development plan and clinical study design, implementation and timely execution, in collaboration with the cross-functional team
  • Assesses study progress against objectives and plans and proactively communicates to the team any issues or challenges and potential mitigation strategies
  • Develops target product profiles, clinical sections for investigator brochures, and other relevant clinical documents, in collaboration with the team
  • Serve as expert medical and scientific point of contact for regulatory and ethics committee interactions
  • Works with regulatory and other internal stakeholders in the preparation and submission of regulatory filings and other regulatory documentation.
  • 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 and clinical investigators; leads interactions including advisory boards, medical meetings and congresses
  • Serve as medical monitor on relevant clinical trials
  • Collaborates with Research and Translational Sciences to design scientifically rigorous clinical studies or other assessments (biomarkers) and to ensure an integrated assessment and interpretation of data

 

 

Required Experience

  • M.D. or M.D./Ph.D. with board certification or eligibility in Oncology or Immunology with significant experience in early stage drug development in oncology (First-in-human Phase 1, Phase 1b and Phase 2 POC studies)
  • Candidates who are not specialty trained should have demonstrated clinical development experience and proficiency in oncologic diseases
  • Minimum of 5 years of pharma/biotech industry experience
  • Direct experience that includes authoring clinical development plans, responsibility for clinical trial design and execution, preparation and submission of US/EU/global regulatory filings, preparation and understanding of product and safety profiles
  • Experience in publishing results of clinical drug trials in peer-reviewed journals
  • Must be comfortable in assessing complex problems and synthesizing solutions based on evolving datasets and information
  • Demonstrated expertise in efficacy and safety data analysis, interpretation and communication
  • Basic understanding of biostatistics methodology
  • Ability to effectively communicate complex scientific concepts to broader audience
  • Comprehensive understanding of competitive activity in the field and diseases of interest
  • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus

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'