Assoc Director, Clinical Project Manager & Drug Development– FSP

Thermo Fisher Scientific • OH

77d

About The Position

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. This individual will be leading the project's overall delivery, collaborating closely with their project team and ensuring that results are met (quality, cost, and time). 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. In this particular role this candidate will also be responsible for any high level plans & progress from pre-clinical into commercial. In addition, they add indication overarching activities and milestones for which they document downstream impact and justification of change to include project budget and resourcing. They partner with the Asset Strategy Lead and the function Leads constituting the EDST or AST. This individual will then compile and own the integrated cross-functional project plan, translating the corporate strategy.

Requirements

• 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.
• Must have Sponsor, Biotech experience.
• Demonstrated leadership skills.
• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.

Nice To Haves

• Strong Project Management skills.
• Understanding of pre-clinical drug development activities, CMC, regulatory and commercial activities.
• Ability to translate strategic plans into operational plans, control timelines and finances.
• Strong communication skills for working cross-functionally with both internal & external business functions.

Responsibilities

• Serves as the lead between the sponsor and the organization at the project level.
• Ensures clear delineation in responsibilities and communication pathways for secondary project leads.
• 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.
• Drives 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees