Sr Director, Project Management, Non-Interventional Clinical Trials Team - Remote in the US

Thermo Fisher Scientific; North Carolina; Remote; USD 120,000 - 160,000; Full time

Job summary

A leading company in clinical research is seeking a Senior Director of Project Management for the North America region. This remote role focuses on overseeing non-interventional clinical trials, ensuring efficient project delivery, and leading strategic initiatives. Candidates should have extensive experience in project management and regulatory affairs, with a strong emphasis on leadership and problem-solving skills. Join a mission-driven team dedicated to making the world healthier, cleaner, and safer.

Qualifications

• 15+ years of relevant experience, including 7+ years in management.
• Expertise in clinical trial regulations and project management.

Responsibilities

• Manage staff and oversee project delivery in clinical trials.
• Collaborate with teams to ensure successful project execution.
• Develop strategies for proposals and manage client portfolios.

Skills

Leadership

Analytical Skills

Problem Solving

Negotiation

Customer Service

Education

Bachelor's degree

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

This position REQUIRES an expertise in management and oversight of Non-Interventional Clinical Trials in a CRO/Pharma setting.

Senior Director Project Mgmt – Oversight

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.

Our Project Delivery colleagues within our PPD clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials. This includes collaborating with functional area leads to identify and evaluate fundamental issues on the project and to ensure that solutions are implemented. Project Delivery is vital to helping our customers deliver life-changing therapies.

Through our global team, you may engage in diverse initiatives and projects, or be part of a virtual international project team gaining cross-cultural experience. Therapeutic scopes include: infectious and respiratory diseases, oncology/hematology, neurosciences, cardiovascular and metabolic, general medicine and vaccines.

Discover Impactful Work:

We are seeking a Senior Director, Project Management in our Non-Interventional Oversight Team . This role is for the North America region and is remote based.

This role provides real world expertise to ensure efficient project delivery, demonstrating the ability to respond swiftly and effectively to escalations. The Director encourages critical thinking in Project Leads, particularly regarding operational execution, financial negotiations, and risk management. Additionally, they lead the development of strategies for proposals and pre-proposal opportunities, ensuring alignment with broader business objectives.

A day in the Life:

• May manage staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
• Accountable for strategic indication or client-specific portfolio management within a Therapeutic Unit.
• Serves as senior level or executive contact.
• May review financial forecasting of TA.
• Acts as a Champion for organizational changes, offerings, developments and lead workstreams.
• Expertly navigates the need to dive in/dive out of situations while ensuring the Project Lead remains empowered.
• Provokes critical thinking and drives innovation in Project Lead related to execution of delivery, financial negotiations and prioritization.
• Provides insight into proposal strategy in prep for bid defense.
• Initiates collaboration with Therapeutic Unit Head in development and implementation of business growth strategies.
• Maintains awareness and engages as appropriate in the Con Mod process.
• Communicates with People Manager(s) to support the development of the employee providing expertise and perspective related to client needs, indication and therapeutic knowledge.

Keys to Success:

Education

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years).
• 7+ years of management responsibility
• Advanced leadership skills

Knowledge, Skills, Abilities

• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc.
• Advanced understanding of medical terminology, statistical concepts, and guidelines
• Outstanding analytical, investigative, and problem-solving skills, including complex evaluations of intangible variables
• Expert financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management
• Accomplished executive presence and consultation and presentation skills
• Superior critical and strategic thinking skills that accounts for a broad impact
• Excellent coaching and leadership skills
• Exceptional customer service, relationship building and stakeholder management skills
• Expert negotiation and marketing skills with ability to influence others and drive results
• Superior judgment, decision making, escalation and risk management skills
• Proven ability to drive corporate strategies to capture, engage and retain repeat customers

Work Environment

Thermo Fisher Scientific 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.
• 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.