Associate Director - Project Management - FSP - Drug Development exp
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
The PPD FSP Solution:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.
Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
Discover Impactful Work:
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:
-
Master’s or Bachelor’s degree in Life Sciences, or a related field, or equivalent experience.
-
At least 10 years of drug development experience in distinct phases of development, in different disease areas, with a broader view on drug development ( pre-clinical / commercial / scientific background)
-
At least 5 years of Program Management experience in a Pharmaceutical or Biotech environment, preferably cross-cultural.
Knowledge, Skills, Abilities
-
Explore understanding and experience of pre-clinical drug development activities and commercial activities
-
Translate strategic plans into operational plans, control timelines and finances
-
Explore natural leadership skills, leading without authority / influencing skills, ability to work within flat organisation/at ease with C-suite
-
Strong analytical skills and attention to detail to identify and resolve issues proactively.
-
Ability to work independently and cross-functionally, leading complex initiatives with minimal oversight.
-
Excellent communication, stakeholder management, and interpersonal skills.
-
Fluent in English (written and spoken).
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:
-
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
-
Able to work upright and stationary for typical working hours.
-
Ability to use and learn standard office equipment and technology with proficiency.
-
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
-
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
-
May require travel. (Recruiter will provide more details.)
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! http://jobs.thermofisher.com
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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.