Associate Director, US Study Start-Up

About the role

The Associate Director, Study Start-up is responsible for providing leadership in the execution of operational strategy and management of start-up activities for all clinical trials, across all therapy areas. This includes, but is not limited to, the overall management and oversight of the following processes: preparation and submission of CTA for EC and CA, site contracts and TPRM for core and CRO-managed countries. The role is accountable for the study start-up metrics (which can be shared with other directors/managers depending on local leadership roles, where appropriate).

Responsibilities

• Ensure timely start-up of all clinical studies across multiple therapeutic areas to agreed start-up timelines according to set metrics, budget, and quality target, working according to country/regional (where appropriate) regulations, GSK SOPs, and ICH GCP.
• Support operations between the central GSK study team, global SSU team, and within-country study team for study start-up activities.
• Accurately forecast critical study timelines related to study start-up activities within-country.
• Maintain clear internal team communication and documentation to ensure site activation timelines are met.
• Manage country feasibility, site selection, recruitment planning, site training, and/or regulatory package completion.
• Work with stakeholders to simplify/optimize processes as it relates to their area of expertise. Identify and share best practices.
• Connect with local internal and external experts to stay updated with changes in site start-up requirements. Learn from past site activations and continuously improve future activities.
• Consult for the LOC CRO’s oversight (operational aspects) when studies are delivered through the FSO (Fully Study Outsourced) Model.
• Leverage AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations.
• Represent GSK in key events (i.e., Forum, Symposium, Trade Association, etc.) and discussions related to the improvement of clinical research activities in the national environment.
• Lead Study Start Up Leads and/or Local Clinical Operations Specialists to ensure timely start-up, operational management, completion, and delivery of all clinical studies across multiple therapeutic areas to agreed start-up timelines according to UQ (Upper Quartile), budget, and quality target, working according to country/regional regulations, GSK SOPs, and GCP.
• Manage resource allocation to maintain business performance and a sustainable workload.

Qualifications

• University degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area.
• 5+ years of experience in clinical operations or similar positions in the pharmaceutical industry.
• Solid knowledge of ICH-GCP, local regulations, and regulatory processes.
• Experience managing study start-up activities across multiple sites in the US.

Preferred Qualifications

• Advanced degree such as Master’s, PharmD, or PhD.
• Demonstrated leadership skills and experience working in matrix teams.
• Experience in budget control and monitoring of performance indicators.
• Analytical skills and a results-oriented mindset, with a focus on operational efficiency and quality.
• Proven track record of reducing study start-up timelines or improving activation metrics.
• Strong stakeholder engagement, negotiation, and influencing skills.
• Experience leading cross-functional projects or process improvement initiatives.