Director, US Portfolio Delivery (cross-TA)
在 GSK,我们对患者有大胆的野心,目标是在十年底前积极影响25亿人的健康。我们的研发专注于发现和提供疫苗和药物,将免疫系统的理解与先进技术结合在一起,以改变人们的生活。GSK 培养了一个为病人抱负的文化,负责影响力,致力于做正确的事情,确保我们把努力集中在加速满足患者需求并具有最高成功概率的重要资产上。我们正在联合科学,技术和人才共同克服疾病。工作目的 美国投资组合交付总监 (US 本地交付首席总监)为全球研发计划提供领导,监督和本地美国研究的交付.LDL-总监负责一系列资产组合,并管理了美国项目领袖 (PLs) 和美国本地交货领袖 (LDLs) 的活动,以确保临床研究按照所需质量标准,GSK 书面标准和 ICH GCP 进行交付。LDL-总监在高度复杂,高体积,战略市场上独立有效运作。关键责任:· 领导一个由 LDL 组成的团队,由于规模 (每项研究中的科目/地点数量)和美国进行的研究数量而处于高度复杂环境中。提供培训,辅导,指导,线路和绩效管理。·负责有效地管理 LDL 的能力利用,确保能力与研究需求,资源可用性和业务优先事项保持一致。·通过参与适用的领导团队来促进 LOC 内的临床研究总体管理,以确保资源和最佳实践的一致性和利用。·负责确保在分配的投资组合内完成所有研究成果,按照达成的时间表,预算和质量标准.LDL-总监与 LDL 合作确定或解决可能影响研究交付的风险和问题或升级。·负责识别和分享最佳实践,统一美国各地并代表当地/地区临床运营全球和跨职业倡议。·招募和开发 LDL.评估内部人员的能力和能力,确定和协调直接报告个人发展计划实施。· 与本地和中央团队合作以确保。
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At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Job Purpose
The Director of US Portfolio Delivery (“US Local Delivery Lead Director”) provides leadership, oversight and local US delivery of studies in support of global R&D programs. The LDL-Director is accountable for a portfolio of assets, and manages the activities of US Program Leads (PLs) and US Local Delivery Leads (LDLs) to ensure the delivery of clinical studies to the required quality standards, GSK written standards and ICH GCP. The LDL-Director operates independently and effectively in a highly complex, high volume, strategic market.
Key Responsibilities:
- Lead a team of LDLs operating in a highly complex environment due to scale (number of subjects/sites per study) and number of US studies conducted. Provide training, coaching, mentoring, line and performance management.
- Responsible for effectively managing capacity utilization of LDL ensuring alignment of capabilities with study requirements, resource availability and business priorities.
- Contribute to overall management of clinical research within the LOC via involvement in applicable leadership teams to ensure consistency and utilization of resources and best practice.
- Accountable for ensuring the completion of all deliverables for studies within assigned portfolio to agreed timelines, budget and quality standards. The LDL-Director works with the LDLs to identify and resolve or escalate risks and issues that may impact study delivery.
- Responsible for identifying and sharing best practices, standardizing across the US and representing local/regional clinical operations on global and cross functional initiatives.
- Recruits and develops LDLs. Evaluates capabilities and competencies of internal staff, identifies and coordinates implementation of personal development plans for direct reports.
- Partners with local and central teams to ensure robust study feasibility with reference to study complexity, clinical facilities and monitoring resource.
- Establishes and manages key strategic relationships with external vendors to ensure clinical studies are appropriately resourced and executed as necessary.
- Ensures that critical study timelines related to study activities are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met. Provides trouble-shooting and problem resolution support for LDLs to ensure productive, efficient study delivery.
- Assists with audits/inspections of local clinical operations department & study / sites in the country, as required.
- Continuous development of knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring technologies and capabilities.
- Leads or participates in regional/global clinical operations projects (as appropriate).
- Available and willing to travel as job requires.
Why You?
Basic Qualifications:
- University degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area
- At least 10 years of experience in clinical operations delivery within the pharmaceutical or biotech industry, including leadership of complex, multi‑site clinical studies in the US.
- At least 5 years of experience leading and developing clinical operations leaders or managers (e.g., LDLs, study managers, CTMs) in a high‑volume, high‑complexity environment.
- Demonstrated accountability for study delivery to timelines, quality standards, and regulatory requirements, including risk identification, issue escalation, and problem resolution.
- Strong working knowledge of ICH‑GCP, GSK written standards, and US regulatory expectations.
Preferred Qualifications:
- Experience leading delivery across late phase and/or registrational cardiovascular, vaccines and/or steatotic liver disease studies is highly valued.
- Experience leading delivery of a portfolio of studies across multiple asset teams.
- Experience delivering clinical trials in the US, including studies with large site networks, complex protocols, and competitive enrollment environments.
Skills
Agile Thinking, Business Acumen, Clinical Development, Clinical Trial Designs, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, People Management, Pharmaceutical Industry, Project ManagementThe US annual base salary for new hires in this position ranges from $153,750 to $256,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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Originally posted on Himalayas