Director Project Management - Rare Disease & Pediatrics- Remote, US
工作概述：作为复杂临床研究或计划的主要客户，推动多家供应商和团队的运营交付。开发并执行风险管理策略，解决升级项目问题，为项目管理人员提供线路管理和人才发展。责任总结：· 首要客户联系分配的临床研究或者方案，独立地与通常高度复杂的战略合作，多家供應商，没有规划监督的子 CRO.可能有其他项目经理在一个矩阵环境中工作，程序水平监督。· 专注于运营交付，制定风险管理和控制策略并改善运营执行。利用员工最大限度地发挥贡献和组织效率 · 促进解决项目级问题升级 ·监督个人参与者和/或项目经理的线路管理和人才发展 · 在这个角色中取得成功，需要利用经验来推动解决方案，发展和维护与各级关键利益相关者建立牢固的关系，扩大客户组合以及通过培训，分配和持续指导经验丰富团队成员，促进增长目标。· 领导项目团队以方便所有项目计划的成功设计，实施，跟踪和维护，遵守专业标准和 SOP,根据合同时间表和预算。· 负责包括 TMF 索引和计划在内的 TMF,审计准备性和按协议日期交付 TMF,当客户签订时。·积极领导质量控制和风险保证活动，以满足监管，内部和客户要求 ·通过有效沟通和合作促进客户体验。•可以作为战略客户关系的主要联系人。制定和管理战略关系层面的基本文件，包括章程书，MSA 谈判，利率卡输入，运营和质量计划等。启动改善流程以解决差异性问题 ·设计大型竞标防御交付策略并执行其他业务发展活动 ·吸引，选择，加入，培养和保持高绩效的人才，加强人才位及继承；
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Job Overview:
Acts as the primary client lead for complex clinical studies or programs, driving operational delivery across multiple vendors and teams. Develops and executes risk‑management strategies, resolves escalated project issues, and provides line management and talent development for project management staff.
Summary of Responsibilities:
- Primary client contact for assigned clinical studies or programs, working independently with generally highly complex strategy, multiple vendors, sub-CROs with no planned oversight. May have other Project Managers working in a matrix environment with program level oversight
- With a primary focus on operational delivery, develops strategies to manage risk and control and improve operational execution. Utilize staff to maximize contribution and organizational effectiveness
- Contributes to resolution of escalation of project level issues
- Oversees the line management and talent development of Individual Contributors and/or Managers of Project Managers
- Success in the role involves leveraging experience to drive solutions, developing and maintaining strong relationships with key stakeholders at all levels of the business, and expanding client portfolios as well as contributing to growth objectives through training, allocation and ongoing mentorship of experienced team members
- Leads the project team to facilitate the successful design, implementation, tracking and maintenance of all project plans, adhering to professional standards and SOPs, according to contracted timelines and budget
- Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of the TMF per agreed upon timelines, when contracted by client
- Proactively lead quality control and risk assurance activities to meet regulatory, internal and client requirements
- Fosters positive client experiences through effective communication and collaboration
- May serve as a primary contact for a strategic client relationship. Develops and manages strategic relationship level fundamental documents, including charters, MSA negotiation, rate card input, operations and quality plans, etc. Initiates process improvement to address variance
- Designs delivery strategy for large scale bid defense and performs other business development activities
- Attracts, selects, onboards, develops and retains high performing talent, strengthens talent bench and succession
- All other duties as needed or assigned
Qualifications (Minimum Required):
- Fluent in English, both written and verbal
- Extensive knowledge of the clinical development spectrum and ICH GCP
- Advanced proficiency in organizational and time management skills
- Demonstrates sound judgment in high-stakes or ambiguous situations
- Exceptional presentation skills for all levels including internal and partner executive leadership
- Actively contributes to continuous improvement efforts and strategic planning activities
Experience (Minimum Required):
- University/college degree in life sciences, Masters preferred
- Minimum of nine (9) years relevant clinical research experience in a pharmaceutical company/CRO including at least six (6) years of full project management responsibility
- Minimum of four (4) years direct or indirect supervisory experience
- In lieu of above experience requirement, a combination of other relevant and equivalent experience may be considered
- Preferred therapeutic areas: rare diseases, neonatal and infant pediatric studies
Preferred Qualifications Include:
· PMP or certified in clinical research
Pay Range: $160,000-$180,000 USD
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.
Application Deadline: 10/23/2026
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Originally posted on Himalayas