高级总监，医学开发负责人
Senior Director, Medicine Development Leader
医学开发负责人（MDL）对核心资产团队（CAT）内肾病学项目的临床开发策略的制定、推动和代表负有全面责任，包括获益/风险评估、药物警戒（PV）和安全性。MDL领导医学开发团队（MDT），并与治疗领域（TA）负责人紧密合作，确保CAT、MDT和其他相关团队（如研究团队）之间的适当沟通流程。
主要职责
- 推动所负责化合物在整个药物生命周期中的临床开发策略，从概念验证到多个治疗适应症的全球监管批准/市场准入。
- 提供临床和科学专业知识，制定并执行资产策略，优化项目成功。
- 与职能成员、TA负责人和CAT负责人共同制定整合项目计划（IPP）文件。
- 与其他职能识别项目风险，并制定缓解策略以应对这些风险。
- 向内部（包括首席执行官和组织执行委员会）和外部利益相关者（卫生当局、指导委员会、独立数据监测委员会和患者组织等）介绍肾病学临床项目，在必要时与各地区的关键意见领袖进行交流。
- 是获益风险团队（BRT）、监管提交团队和标签工作组的核心成员。
- 确保临床开发计划和研究文件获得Sobi治理机构（如Sobi证据生成委员会、研究文件评审论坛）的批准。
- 在矩阵式管理中领导临床科学家和医学开发团队（由医学事务、临床科学、监管、安全/PV、非临床/PK、生物统计/数据管理、临床项目管理、健康经济学与结果研究、真实世界证据、项目管理等领域的代表组成），提供战略指导，并对以下方面负最终责任：
- 临床试验设计（临床研究摘要和方案开发）、规划（例如，选择研究中心和国家）、执行（例如，医学监测、安全问题解决；统计分析的解读）以及研究结果的内部和外部沟通
- 关键文件的临床部分的创建（临床开发计划、临床研究方案、研究者手册、临床研究报告）
查看英文原文
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
The Medicine Development Leader (MDL) has the overall accountability for developing, driving and representing the clinical development strategy for the nephrology program within the Core Asset Team (CAT), including benefit/risk evaluation, pharmacovigilance (PV) and safety. The MDL leads the Medicine Development Team (MDT) and assures, in close collaboration with the TA head, the appropriate communication flow between the CAT, the MDT and other associated teams (e.g. the Study Team).
Key Responsibilities
· Drives the clinical development strategy for the assigned compound(s) across the medicine lifecycle, from proof of concept to successful global regulatory approval(s)/market access for multiple treatment indications.
· Provides clinical and scientific expertise to set and execute the asset strategy and optimize project success.
· Works with functional members, TA head and CAT Leaders to develop Integrated Project Plans (IPP) documents.
· Identifies risks for the program with other functions and develops mitigation strategies to address them.
· Presents the nephrology clinical program to internal (including the CEO and the Executive Committee of the Organisation) and external stakeholders (Health Authorities, Steering Committees, Independent Data Monitoring Committees, and Patient Organisations etc), engages when necessary with Key Opinion Leaders across geographies.
· Is a core member of the benefit risk team (BRT), of regulatory submission teams and of the labeling working group.
· Ensures endorsement of clinical development plans and study documents by Sobi governance bodies (e.g. Sobi Evidence Generation Board, Study Document Review Forum).
· Leads in a matrix the clinical scientists and the Medicine Development Team (consists of representatives from Medical Affairs, Clinical Science, Regulatory, Safety/PV, non-clinical/PK, Biostatistics/Data management, Clinical Program Management, Heath Economics and Outcome Research, RWE, Program Management), providing strategic guidance and being the ultimate accountable for:
· Clinical trial design (clinical study synopsis and protocol development), planning (e.g. sites and countries selection), execution (e.g.medical monitoring, resolution of safety issues; interpretation of statistical analyses) and internal and external communication of study results
· Creation of clinical components of key documents (Clinical Development Plans, Clinical Study Protocols, Investigator’s Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, Clinical Modules of registration dossiers, Briefing Books for interactions with Health Authorities) with high quality and consistency with the Integrated Project Plan and Target Product Profile.
· Provision of required input on clinical efficacy, safety, dosing/administration, mechanism of action, etc for the Target Product Profile (TPP)
· Support to registration and market access (Core Data Sheet, Development Safety Update Report, Periodic Safety Update Report, clinical benefit-risk assessment) o Collaboration with Regulatory team to determine international submission strategy
- Medical degree with 10+ years of relevant clinical experience in academic and/or pharmaceutical Global Research & Development roles
- Solid track record in drug development programmes, preferably within nephrology
- Extensive knowledge of clinical trial methodology, global regulatory requirements, and experience in designing and executing clinical studies
- Advanced knowledge of clinical trial operational aspects, including budget and timeline management
- Demonstrated ability to build and execute strategic and tactical plans
- Experience engaging with key internal and external stakeholders
- Specialty in relevant therapeutic area with at least 5 years clinical experience treating patients and successful interactions with major Health Authorities leading to drug approvals
- Strong leadership skills with demonstrated capability to lead cross-functional teams in a matrix environment
- Ability to coach, mentor, and communicate effectively with all audiences internally and externally
- Excellent organisational skills with self-motivated drive to implement best practices
- Demonstrated ability to evaluate and analyse medical and scientific literature
- Fluent written and verbal communication in English
- Alignment with Sobi's core values: Care, Ambition, Urgency, Ownership, and Partnership
All your information will be kept confidential according to EEO guidelines.