Terns Pharmaceuticals is a global biotechnology company committed to discovering and developing molecularly-targeted, oral, small molecule medicines to treat liver disease and cancer. Based in San Mateo and Shanghai, China, Terns Pharmaceuticals is focused on bringing forward innovative therapeutic candidates with the potential to address significant unmet medical needs in China and world-wide. The company combines expertise in disease biology and medicinal chemistry with a capital-efficient drug discovery model and extensive clinical development capabilities to advance its growing pipeline of medicines.
The candidate we are seeking will be responsible for the design, planning, and medical oversight of clinical studies and strategies for development of various programs from pre-clinical development through regulatory approval. They will collaborate with team members for study implementation and serve as medical monitor for clinical protocols. In addition, they will be responsible for overseeing interpretation and dissemination of study results, including clinical study reports and study related publications.
The successful candidate will serve as a core member of the clinical development team, and will contribute to devising of the overall clinical strategy and ensure all activities occur in compliance with the appropriate regulations. They will work closely with other functions to define strategy and grow the Terns pipeline.
- Contribute to the clinical development strategy for Terns portfolio.
- Oversee the design of clinical studies to ensure that the trials support program development goalsPartner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance.
- Review clinical data from all phases of development and assist in generating study reports and publications.
- Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished.
- Serve as study medical monitor, as needed.
- Identification and management of external collaborators and key opinion leaders/consultants.
- Representing Terns clinical research in interactions with investigators and regulatory agencies.
- Ensure compliance with all applicable regulatory standards related to clinical trials and interactions with physicians.
- Develop and maintain professional relationships with academic and community-based study sites.
Desired Skills and Experience:
- 3+ years of industry experience or combined industry/academic experience.
- Experience in hepatology or endocrinology with a focus on NASH and Liver Diseases is highly preferred.
- Strong scientific background.
- Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
- Experience with study design.
- Significant experience in communicating/presenting key/complex information to department/functional lead(s)/senior management, external investigators and advisors and regulatory authorities.
- Thorough knowledge of clinical medicine and clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
- Ability to multi-task and manage several projects in parallel, paying attention to detail.
- Ability to forge cross-functional working relationships with internal teams and external project partners.