Director of US Oncology Portfolio Delivery
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 美国肿肿瘤学投资组合交付总监 (US 本地交付首席总监)为全球肿肿瘤学研发计划提供领导,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,以确保所有肿肿瘤学临床研究都达到所需质量标准,GSK 书面标准和 ICH GCP.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)和对其他研究进行的体积 (指导,辅导,线路和绩效管理),在高度复杂环境中运作。·负责有效地管理 LDL 资源的能力利用,并为包括 LDL 多国支持的资源解决方案提供贡献,确保能力与学习需求,资源可用性和业务优先事项相一致。通过参与适用的领导团队,确保资源和最佳实践的一致性和利用。·负责确保所有项目管理成果在经过协议的时间表,预算和质量标准下完成所有项目的项目管理结果.LDL 经理与 LDL 合作确定或解决或升级可能影响研究交付的风险和问题。·负责识别和分享最佳实践,将项目管理成果统一化到 LOC/地区范围内,并代表全球和跨功能倡议上的本地/区域临床运营。了解和应对独特的 chal 的能力
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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 Oncology Portfolio Delivery (“US Local Delivery Lead Director”) provides leadership, oversight and local US delivery of studies in support of global oncology 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 all oncology 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:
- Leads a team of LDLs operating in a highly complex environment due to scale (number of subjects/sites per study) and volume (number of studies assigned to contry) of studies conducted, providing training, coaching, mentoring, line and performance management.
- Responsible for effectively managing capacity utilisation of LDL resources and contributes to resourcing solutions including multi-country support by LDLs, 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 utilisation of resources and best practice.
- Accountable for ensuring the completion of all project management deliverables for all studies assigned to the LOC to agreed timelines, budget and quality standards. The LDL manager 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 LOC / region and representing local/regional clinical operations on global and cross functional initiatives. Ability to understand and respond to unique challenges in managing workload due to size and scale of studies.
- 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.
- In collaboration with Clinical Operation Director and Local/Regional Quality, Capability & Risk Manager identifies management monitoring process checks linked with LDL activities that require inclusion in the local quality plan to ensure quality and integrity of clinical studies conducted in the LOC.
- 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. Serves as an expert in ICH GCP and GSK written standards for LDLs.
- 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.
- At least 5 years of experience delivering oncology clinical trials in the US, including studies with large site networks, complex protocols, and competitive enrollment environments.
- At least 3 years of experience leading delivery of a portfolio of oncology studies across multiple asset teams.
Preferred Qualifications:
- 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.
- Experience leading delivery across late phase and/or registrational oncology studies is highly valued.
- Familiarity with oncology specific operational challenges, such as:
o High protocol complexity and amendment frequency
o Specialized site types and networks
o Competitive enrollment and site capacity constraints
· Experience operating across multiple oncology indications or programs within a portfolio.
Skills
Agile Thinking, Business Acumen, Clinical Data Management, Clinical Development, Clinical Research, Clinical Trials, Communication, Creativity, Decision Making, Pharmaceutical Industry, Project ManagementThe US annual base salary for new hires in this position ranges from $169,500 to $282,500. 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