Website HanchorBio Inc.
- Develop, execute and maintain clinical development plans (biologics) including Phase 1 through 3, lifecycle management, medical affairs, safety responsibilities, scientific interactions with regulatory bodies with strategy and direction; ensure CDPs are executed on time and within budget
- Oversee tactical development of clinical trial programs, including literature reviews, clinical CRO/investigator selection, protocol development, clinical operation, interpretation of clinical data, and proactive detection of operational issues; resolve operational issues including protocol amendments
- Identify strategic issues for therapeutic indications under investigation; keep abreast of critical evolution of therapeutic options for chosen therapeutic indications and alert Senior Management and clinical operation staff to evolve management paradigms
- Orchestrate and manage clinical aspects of regulatory strategies and interactions with regulatory agencies; review and approve all correspondence to regulatory agencies as appropriate; review submission to Ethics Committees, input into responses to any questions/issues raised and support of operational teams
- Interact with KOLs, MSLs and corporate partner(s) and investors
- Ensure that company practices are compliant with relevant drug regulations
- Build, grow and manage a high-functioning clinical organization with a focus on staff development, clinical quality, and appropriate succession planning
- MD degree with 10+ years’ experience in clinical practice treating patients or biotech/pharmaceutical industry experience as a Sponsor working on investigational new drugs.
- Experience with, or strong knowledge of oncology drug development. Experience in clinical pharmacology and early-stage clinical development is desirable.
- Excellent knowledge of the competitive environment for drugs in the oncology marketplace and in research and development pipelines.
- Comprehensive knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
- Able to read, write and speak English and possess excellent written and oral communication, collaboration and “think-out-of-the box” problem-solving skills and will be capable of articulating company clinical and regulatory strategies.
- Must have a results-oriented work ethic, a positive attitude, reliable team player with strong sense of responsibility.
- Comfortable meeting deadline in a fast-paced biotech environment
Please submit your resume and CV to firstname.lastname@example.org and mention that you saw this JD on the SAPA website.