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- Tasks: Lead global clinical studies and manage cross-functional teams to ensure successful project delivery.
- Company: IQVIA is a top global provider of clinical research services, enhancing healthcare through innovative solutions.
- Benefits: Enjoy competitive pay, flexible working options, and opportunities for professional growth.
- Why this job: Join a dynamic team making a real impact in drug development and patient health worldwide.
- Qualifications: 10+ years in pharma with strong project management and clinical trial experience required.
- Other info: This role does not offer UK visa sponsorship.
The predicted salary is between 72000 - 108000 £ per year.
The Global Clinical Operations Program Director (GPD) is a core global role within the Clinical Operations function of Late Stage R&D (BioPharmaceuticals and Oncology). The span of responsibilities is broad and may support one or several products depending on scope and complexity. The products supported will be in Phase 3 development or on the market, but the program may include studies in all phases of drug development. On behalf of the Senior Global Clinical Operations Program Director (Sr GPD), the GPD provides strategic operational leadership and oversight of a suite of global clinical studies within a program covering all clinical program deliverables, covering all clinical operations deliverables to scope, quality, budget, time, resource, and risk, ensuring new innovative design and delivery models are used appropriately. The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with priorities and strategy.The GPD will develop the core clinical operations components for governance interactions with the oversight of the Sr GPD. The GPD may also act as the lead for crossfunctional teams in delivery of clinical program team (CPT) activities assigned. The GPD may provide project leadership for cross-functional clinical submission teams in support of regulatory marketing applications and post-registration product maintenance deliverables. Additionally, the GPD may lead or contribute to improvement and change projects within clinical operations and/or other business areas.We are looking for a senior-level professional to lead the development of a regulatory program in collaboration with the sponsor and IQVIA. The primary responsibility will be project management, ensuring effective coordination and execution across all stakeholders. Prior experience in clinical trial development is essential, as the selected candidate will define regulatory processes, oversee implementation, and prepare key documentation aligned with the new structure. Responsabilities:Lead cross-functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning the resource and managing risk.Work closely with global study leaders to provide appropriate strategic oversight of a program of studies on behalf of Sr GPD and Clinical Program Team (CPT)Provide clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, risks and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, quality, feasibility, risk) On behalf of CPT, responsible for managing clinical plans (cost, FTEs and timelines) in business reporting system, such as PLANITLead large or complex deliverables and the process to identify and solve/escalate operational issues and drive delivery to plan through internal or external partners (Alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)).Act as the sponsor point of escalation for study teams for external (e.g. CRO) partners for externally managed/outsourced studies as appropriate Responsible for leadership and program management of non-drug project work as assigned, e.g. cross functional improvement/change initiativesProvide project leadership & management to cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications (aligning closely with other key contributors to submission package)Lead cross-functional teams in delivery of assigned clinical program team (CPT) activitiesContribute to functional and cross-functional initiatives as Subject Matter ExpertsMentor, coach and support people development as appropriate.Actively participate in networking both within and outside the therapeutic area, sharing best practises and lesson learntBe an early adopter for new ways of working and act as ambassadors for change, driving the implementation and utilization of new initiativesQualifications:University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.Advanced degree is preferred.At least 10 from within the pharmaceutical industry or similar large multinational organizations.Proven knowledge of project management tools and processesProven experience in clinical development/drug development process in various phases of development and therapy areas.Proven ability to learn by working in multiple phases, TAs, and/or different development situations.Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).Ability to mentor, develop and educate staffProven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectivesSkilled & experienced in change managementAbility to look for and champion more efficient and effective methods/processes of delivering clinical operations components focusing on key performance metrics around reliability, productivity, cost, and qualityExcellent written and verbal communication skills, negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organizationDemonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environmentIntegrity and high ethical standardsExcellent stakeholder management skillsAdaptabilityRegulatory submission experienceProven knowledge of clinical operationsExperience with development and implementation of digital health initiatives in Clinical Studies*Please note This role is not eligible for UK visa sponsorship IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Associate Global Clinical Operations Director - Sponsor Dedicated employer: jobwache
Contact Detail:
jobwache Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Global Clinical Operations Director - Sponsor Dedicated
✨Tip Number 1
Network with professionals in the clinical operations field, especially those who have experience in late-stage R&D. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in clinical trials.
✨Tip Number 2
Familiarise yourself with project management tools commonly used in clinical operations. Being proficient in these tools can set you apart, as they are essential for managing timelines, budgets, and resources effectively.
✨Tip Number 3
Stay updated on regulatory requirements and changes in the pharmaceutical industry. Understanding the nuances of regulatory submissions will enhance your credibility and demonstrate your commitment to the role.
✨Tip Number 4
Showcase your leadership skills by discussing past experiences where you successfully led cross-functional teams. Highlight your ability to mentor and develop others, as this is a key aspect of the Associate Global Clinical Operations Director role.
We think you need these skills to ace Associate Global Clinical Operations Director - Sponsor Dedicated
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical operations and project management. Emphasise your leadership roles and any specific achievements in drug development phases, particularly Phase 3.
Craft a Compelling Cover Letter: In your cover letter, address how your background aligns with the responsibilities of the Associate Global Clinical Operations Director role. Mention your experience with cross-functional teams and your ability to manage complex projects effectively.
Highlight Relevant Skills: Clearly outline your skills in stakeholder management, change management, and communication. Provide examples of how you've successfully led teams or projects in the past, especially in a pharmaceutical context.
Showcase Your Knowledge: Demonstrate your understanding of regulatory processes and clinical trial development in your application. Mention any specific tools or methodologies you are familiar with that are relevant to the role.
How to prepare for a job interview at jobwache
✨Understand the Role Thoroughly
Before the interview, make sure you have a deep understanding of the Associate Global Clinical Operations Director role. Familiarise yourself with the responsibilities and expectations outlined in the job description, especially around project management and cross-functional team leadership.
✨Prepare for Scenario-Based Questions
Expect to be asked about specific scenarios related to clinical operations and project management. Prepare examples from your past experiences that demonstrate your ability to lead teams, manage risks, and deliver projects on time and within budget.
✨Showcase Your Leadership Skills
This role requires strong leadership capabilities. Be ready to discuss how you've motivated and empowered teams in previous positions. Highlight any mentoring or coaching experiences that showcase your ability to develop others.
✨Demonstrate Adaptability and Innovation
The company values innovative approaches to clinical operations. Be prepared to discuss how you've embraced change and implemented new processes or technologies in your previous roles. Show that you're an early adopter of new ways of working.