保存工作 返回搜索结果 职责描述 职位概要 类似职位 Lead early clinical development for an innovative biotech High-impact, hands-on role reporting directly to the CEO 关于我们的客户 Our client is an innovative, science-driven biotechnology company developing novel therapeutics in Immunology & Inflammation (I&I).With a growing pipeline progressing into clinical development, the company is strengthening its clinical leadership team and is seeking an experienced Clinical Development Head to help shape and execute early-stage clinical programs.This is a highly visible and hands-on position, working closely with the CEO and cross-functional leadership team. The appointment can be made at Director, Senior Director or VP level, depending on the experience and track record of the successful candidate. 职责描述 The Director / Senior Director / VP, Clinical Development will play a key role in translating the company's scientific pipeline into differentiated clinical development programs, with a particular focus on Phase 1, Phase 1b and Phase 2 studies in I&I indications.Key responsibilities will include: Develop clinical strategies for the company's I&I pipeline, including indication selection, target product profiles, development plans and key clinical decision points. Lead or support the design and execution of Phase 1, Phase 1b and Phase 2 clinical trials, including objectives, endpoints, eligibility criteria, safety monitoring and dose-selection strategies. Provide medical and scientific leadership across protocols, investigator brochures, clinical study reports and regulatory documentation. Review and interpret emerging safety, efficacy and biomarker data, contributing to dose escalation, dose selection and critical go/no-go decisions. Work closely with Clinical Operations, Regulatory, Safety, Biostatistics, Data Management and CMC, as well as external CROs, investigators and consultants, to ensure efficient study execution. Support interactions with health authorities, KOLs, investigators, scientific advisors and external clinical experts. Provide clear recommendations to the CEO and leadership team regarding program progress, clinical data, key risks and development strategy. Contribute to broader portfolio and development discussions as programs progress through the clinic. Help build and develop the clinical development function as the organization and pipeline continue to expand. 理想的求职者 Advanced scientific or medical training relevant to clinical drug development. Medical training is preferred but will not be essential for an exceptional candidate. At least 4+ years of clinical development experience within the biotechnology or pharmaceutical industry, with more experienced candidates considered for Senior Director or VP level. Demonstrated experience in early clinical development and Phase 1/2 clinical trial design and/or execution. Direct experience with Phase 2 development would be highly advantageous. Previous exposure to Immunology & Inflammation is strongly preferred, with experience in dermatology, rheumatology, allergy/immunology, gastroenterology or hematology particularly relevant. Strong scientific judgment and the ability to interpret emerging clinical, safety, efficacy and biomarker data and translate findings into development decisions. Working knowledge of GCP, ICH and major global regulatory requirements. Previous interaction with FDA, EMA and/or NMPA would be advantageous but is not a prerequisite. Experience collaborating effectively with CROs, investigators, KOLs and multidisciplinary internal teams. Strong communication skills in English. Mandarin would be an advantage for candidates supporting China-based clinical execution. A practical, entrepreneurial and hands-on working style, with the ability to operate effectively in a fast-moving emerging biotech environment. 薪酬待遇 Opportunity to take a high-impact clinical development leadership role within an innovative biotechnology company. Direct exposure to the CEO and senior leadership team, with meaningful influence over clinical and portfolio strategy. Opportunity to shape early clinical development strategy from Phase 1 through Phase 2 across an emerging I&I pipeline. Broad responsibilities spanning clinical strategy, trial design, medical oversight, data interpretation and regulatory interactions. Opportunity to help build the clinical development organization as the company's pipeline expands. Flexible seniority from Director through VP, allowing scope and responsibilities to reflect the successful candidate's experience. International exposure across China and the US, working with global scientific, clinical and regulatory stakeholders. 联系 Maria Karp 职位编号 JN-082026-7088450 联系电话 +8621 6026 8139 职位概要 职位类别 生命科学 子类别 生物技术 行业 医疗保健/制药 地区 中国 工作类型 全职 顾问名字 Maria Karp 顾问电话号码 +8621 6026 8139 职位编号 JN-082026-7088450
