Cambridge, Massachusetts, USA
1 day ago
Associate Director/Senior Project Manager, Drug Development, FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

AD Project Management/Senior Project Manager (Delivery)

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.

Position: Associate Director/Senior Project Manager, Drug Development, FSP

Location: Remote, US

Discover Impactful Work:

This individual will be leading the project's overall delivery, collaborating closely with their project team and ensure that results are met (quality, cost, and time) expectations on behalf of the organization. Leads the cross-functional project team to meet or exceed deliverables. Responsible for project(s) of increasing complexity (such as but not limited to: multi-service, multi-region/country, therapeutic complexity, financial scope).

A day in the Life:

Serves as the lead between the sponsor and the organization at the project level.

On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).

Drives and leads the overall delivery of the cross-functional project (time, cost, quality).

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 handles 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.

Experience & Education

At least 5-8 years of Program or Project Management experience in a Pharmaceutical or Biotech environment, preferably cross-cultural.

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)

Shown leadership skills

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

Expectations:

This candidate must have strong Clinical Project Management skills

Must have an understanding of pre-clinical drug development activities and commercial activities

Translate strategic plans into operational plans, control timelines and finances

Strong communication skills is vital for this role, this person will be responsible for working cross functionally with both internal & external business functions.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

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