Associate Director - Project Management - FSP - Drug Development exp

Job Opportunity At Thermo Fisher Scientific

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

May serve in a Project Lead role, Oversight Director role or People Manager role within the Project Delivery Organization. Serves as the Project Lead and primary sponsor contact. Accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Establishes and communicates customer expectations to the project team with minimal direction. Ensures that escalation pathways are adhered to internally and externally. Leads the cross-functional project team to meet or exceed deliverables. Manages project(s) of increasing complexity (such as but not limited to : multi-service, multiregion / country, therapeutic complexity, financial scope). The Oversight Director is accountable for strategic indication or client-specific portfolio management within a Therapeutic Unit. Provides therapeutic expertise in project delivery execution, demonstrating the ability to react quickly and appropriately to escalations. Provokes critical thinking in the Project Lead related to delivery operations, financial negotiations and risk mitigations / issue management for a project. Contributes to overall strategy development for proposals and pre-proposal opportunities. The People Manager directs a team of Project Delivery direct reports of differing levels of experience and project roles within a Therapeutic Unit. Accountable for the career development and performance management of their team, providing coaching in both soft skills and technical skills as related to the use of organization systems, tools and processes. Adept at identifying and addressing training gaps, while maintaining employee motivation and trust. The people manager fosters the ability to collaborate and balance business need with career development opportunities.

A day in the Life :

• Serves as the primary contact between the sponsor and the organization at the project level.
• Lead cross-functional teams in the development, optimization, and execution of eCOA frameworks to ensure efficiency, compliance, and seamless trial execution.
• Serve as the eCOA SME across the organization, providing expert guidance throughout the end-to-end (E2E) process to ensure best practices and regulatory compliance.
• Ensures financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process / negotiations and team execution to timelines.
• Establishes, communicates and manages customer expectations to achieve optimal delivery during the project.
• Drives Risk Identification and Issue Resolution at project level (RBQM / RESOLVE).
• Ensures project team compliance with organization policies, SOPs, ICH-GCP, regulatory and project specific requirements
• Oversee third-party vendors for copyright, translations, and library services, ensuring compliance with licensing agreements and regulatory requirements.
• Design and implement a comprehensive training program to enhance internal expertise on eCOA processes, compliance requirements, and industry best practices.
• Ensure continuous regulatory inspection readiness, maintaining complete documentation (including eCOA training), audit trails, and compliance with global regulatory requirements (ICH-GCP, FDA, EMA, and industry guidelines).

Keys to Success :

Knowledge, Skills, Abilities :

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment / requirements for this role :

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO / Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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