Less than 5 years experience • Pharmaceuticals & Biotech
Tracking Code 182-181
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). 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 an experienced medical director to join our growing clinical development organization. The successful candidate is a strategic thinker who will help implement clinical development strategy for one or more of NGM’s assets by leveraging a thorough understanding of disease landscape, unmet clinical need, competitive landscape and other salient factors. The medical director will act as the internal medical and scientific expert on relevant programs. The medical 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.
- Act 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
- At least 3 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 Candidates who are ophthalmologists should have experience in and a desire to work in other therapeutic areas.
- At least 4 years of integrative 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