Job Summary

Responsibilities

Operational Strategy: Develop and implement ESR team operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and outcomes, addressing potential issues proactively and ensuring adherence to timelines.

Program Leadership: Lead and manage multiple research programs, demonstrating expertise in both strategy formulation and operational execution in the field of externally sponsored research. Provide clear direction and guidance to project teams.

Committee Facilitation: Facilitate review committee meetings, ensuring comprehensive documentation of meeting outcomes, decisions, and action items. Coordinate with stakeholders to ensure timely follow-up and resolution of issues.

Clinical Trial Management: Oversee clinical trial functions including CTA negotiations, Fair Market Value evaluations, milestone follow-ups, study enrollment updates, study reports, and closeout procedures. Work closely with study site operational staff to ensure timely and accurate updates.

Project Management: Demonstrate advanced project management skills, facilitating discussions with internal and external cross-functional teams. Present findings and project statuses to cross-functional leadership and alliance management teams.

Budget Management: Exhibit strong budget management experience, including forecasting, reforecasting, and managing plan vs. actuals. Preferably, have experience managing global studies involving multiple currencies and complex financial tracking.

Vendor and Site Management: Direct and enhance interactions with investigator sites and other external vendors to ensure projects are delivered on time, within budget, and meet high-quality standards. Ensure effective communication and issue resolution.

Communication and Collaboration: Foster and maintain effective communication channels within a global, multi-disciplinary team environment. Ensure alignment and collaboration across functions, regional ESR and Medical teams as well as alliance partners, promoting a cohesive team approach.

Regulatory and Safety Compliance: Understand study conduct from supply chain/drug forecasting to safety and regulatory requirements related to studies using investigational drugs and commercial products. Demonstrate experience in various types of studies across all phases, with a preference for oncology.

This position may require the supervision of functional and/or direct reports by providing instruction and direction of daily activities in support of goals.

Assume potential line management responsibilities for ESR Managers focused on the tactical aspects of study execution. In their absence, take on both strategic and tactical responsibilities to ensure study continuity and success.

Qualifications

Education Qualifications
Bachelor's Degree in the Life Sciences required Master's Degree Life Sciences preferred

Experience Qualifications
4 or more years relevant working experience in externally sponsored research, including IIS and collaborative studies required 
4 or more years in a clinical management setting required 
A robust background in navigating complex regulatory environments and achieving study objectives efficiently and effectively required
Strong understanding of Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines required
Excellent communication, organizational, and problem-solving skills required
Proven people management experience, demonstrating effective leadership and team development preferred


Travel Requirements
Ability to travel up to 10% of the time. In-house office position that may require travel (global).