Director, GCO Process Management

GSK

15h • Hybrid

About The Position

The Director Process Management will be accountable for overseeing and optimizing clinical trial supply management and protocol deviation management processes within Global Clinical Operations (GCO). The Director of Process Management will be a senior leader with expertise in process design, leading complex projects, and operating effectively within a matrix organization.

Requirements

• Bachelor’s degree in Scientific discipline.
• Extensive experience in Pharmaceutical or Biotech industry working in Clinical Operations, Operational Excellence, or a related field.
• Proven experience in designing and managing clinical operations processes such as clinical trial supply management and protocol deviation management, and knowledge of ICH/GCP and global regulatory guidelines for drug development and approval processes.
• Experience leading major projects to completion and driving cross-functional improvements.
• Experience in strategic and critical thinking, problem solving, influencing and decision-making.
• Demonstrated a forward-thinking and visionary approach to modernizing clinical processes and leveraging technology to drive efficiency and innovation
• Demonstrated experience in matrix team leadership to deliver results.
• Demonstrated cross-functional collaborator with experience in building networks of partners and stakeholders and broadly engaging with expert communities.
• Experience in effective communication with ability to communicate and influence.

Nice To Haves

• Advanced degree in Scientific discipline

Responsibilities

• As the Global Process Owner for assigned processes lead the design, maintenance, and continuous improvement of end-to-end clinical processes. Ensure these processes are well defined, comply with regulatory requirements, are aligned with GCO’s strategies, implement innovative approaches being developed in the industry and support effective work. Ensure that written standards are developed and maintained as needed to support the process and that written standards can be clearly understood by end-users. Provide necessary information and training to help users understand and implement these processes effectively.
• Define and implement process oversight strategy with key performance indicators, in-process controls, management monitoring and end-user feedback. Establish benchmarks and conduct periodic review of performance metrics to ensure effectiveness, efficiency, and compliance. Report process health and compliance to the relevant stakeholders proactively and take appropriate measures where deficiencies are identified.
• Influence and engage with the organization by building a strong network with stakeholders, partners, and subject matter experts to understand their drivers and needs along with broader organizational goals. Use these insights to craft alignment, drive meaningful change and improve end-user experience.
• Define and manage process change roadmaps, aligning priorities with system updates and innovations to address evolving business needs, manage risks or interdependencies, and implement improvements at scale.
• Lead strategy, planning, execution, and implementation of process change projects, ensuring improvements are achieved through a combination of process-people-system solutions. Partner with subject matter experts and support roles to deliver a comprehensive solution package that includes the end-to-end process itself, written standards, training, communication, change management, implementation, and monitoring plans.
• Maintain current knowledge of global regulations and guidance, global regulatory expectations, regulation intelligence and industry standards pertaining to the assigned processes. Proactively assess impact of any new regulations on assigned process and ensure ongoing compliance.
• Proactively educate themselves in evolutions and innovations across the industry and evaluate how they could positively benefit the effectiveness, efficiency or compliance of the process. Develop and align proposals with the appropriate stakeholders to drive process innovation that is aligned with GCO’s strategic priorities and stakeholder needs.
• Maintain personal readiness to respond to internal audits and regulatory inspections, be the point of contact and interact with inspectors, and provide expert advice to respond to audit observations.
• Represent GSK in external forums to influence the external ecosystem in shaping industry-leading practices and development of innovative methodologies

Benefits

• We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees