Global Clinical Operations Program Director - Sponsor Dedicated

The Global Clinical Operations Program Director (GPD) is a key role within the Clinical Operations function of Late Stage R&D (BioPharmaceuticals and Oncology). The GPD supports one or multiple products, primarily in Phase 3 development or on the market, but may also oversee studies across all phases of drug development. Reporting to the Senior Global Clinical Operations Program Director (Sr GPD), the GPD provides strategic operational leadership and oversight of global clinical studies, ensuring delivery within scope, quality, budget, time, resources, and risk parameters. The role emphasizes innovative design and delivery models, integrating strategy, design, feasibility, and operational planning to align with business priorities and strategies.

The GPD is responsible for developing core clinical operations components for governance interactions under the oversight of the Sr GPD. This role may lead cross-functional teams in delivering clinical program activities and provide project leadership for clinical submission teams supporting regulatory marketing applications and post-registration maintenance. Additionally, the GPD may lead or contribute to process improvement projects within clinical operations or other business areas.

Responsibilities:

1. Lead cross-functional teams in planning and delivering clinical studies within scope, quality, budget, and timelines, managing risks and resources effectively.
2. Collaborate with global study leaders to oversee a program of studies, supporting the Sr GPD and Clinical Program Team (CPT).
3. Provide expertise on clinical operations aspects such as country selection, feasibility, design input, risk management, and external partner management, utilizing innovative models for governance and startup phases.
4. Contribute to new business cases by assessing costs, timelines, quality, feasibility, and risks; manage clinical plans in business reporting systems like PLANIT.
5. Manage complex deliverables, resolve operational issues, and drive project delivery through internal and external partners, including CROs and vendors.
6. Act as a sponsor point of escalation for external study partners and lead non-drug project work or improvement initiatives as assigned.
7. Lead clinical submission teams in planning and executing clinical contributions to marketing applications, ensuring alignment with key contributors.
8. Mentor and develop team members, promote best practices, and foster networking within and outside the therapeutic area.
9. Champion new ways of working and facilitate the adoption of innovative initiatives.

Qualifications:

• University degree, preferably in medical or biological sciences; advanced degrees are a plus.
• Minimum of 10 years’ experience in the pharmaceutical industry or similar large organizations.
• Strong knowledge of project management tools and processes.
• Experience in clinical development across various phases and therapy areas.
• Proven leadership in managing clinical projects and teams, with skills in change management, stakeholder management, and strategic planning.
• Excellent communication, negotiation, and interpersonal skills.
• Experience with digital health initiatives and regulatory submissions.
• High ethical standards and adaptability.

*Please note this role is not eligible for UK visa sponsorship.

IQVIA is a leading global provider of clinical research services, insights, and healthcare intelligence, dedicated to accelerating medical innovation and improving patient outcomes worldwide. Learn more athttps://jobs.iqvia.com.
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