Associate Director, External Sponsored Research
3 days ago
We are seeking an experienced Associate Director to lead the execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research initiatives. The successful candidate will ensure strict adherence to Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, EU Directives, and International Conference on Harmonization (ICH) guidelines.
Key Responsibilities- Lifecycle Management: Oversee and manage the complete lifecycle of externally sponsored research, including both IIS and collaborative studies, ensuring projects align with strategic goals and compliance standards from initiation through completion.
- Operational Strategy: Develop and implement ESR team operational strategies for externally sponsored studies, serving 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, providing clear direction and guidance to project teams.
- 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, working 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, presenting 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 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, ensuring effective communication and issue resolution.
- Communication and Collaboration: Foster and maintain effective communication channels within a global, multi-disciplinary team environment, ensuring 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, demonstrating experience in various types of studies across all phases, with a preference for oncology.
- Bachelor's Degree in the Life Sciences required
- Master's Degree in Life Sciences preferred
- 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
- Ability to travel up to 10% In-house office position that may require travel (global)
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