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Job Purpose: 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. The responsibilities listed below outline the scope of the position. The application of these tasks may vary, based upon evolving business needs.
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 the 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. GSK is an Equal Opportunity Employer and ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary. Please note if your enquiry does not relate to adjustments, we will not be able to support you through these channels.
Qualifications
- Bachelor's degree in a scientific discipline.
- Extensive experience in the 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 collaboration with experience building networks of partners and stakeholders and engaging broadly with expert communities.
- Experience in effective communication with ability to communicate and influence.
Preferred Qualification
- Advanced degree in a scientific discipline.