Thermo Fisher Scientific

Compensation

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Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description AD Project Management/Senior Project Manager, Drug Development 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. Position: Associate Director/Senior Project Manager, Drug Development, FSP Location: Fully Remote, US Our client, a global mid-sized biotech company, focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing, international organization has a strong scientific foundation. If you'relooking for a place where your work, in partnership with others, can have real impact—and where you're encouraged to challenge yourself and contribute to breakthrough solutions , this role could be a great fit. ​​ Discover Impactful Work: 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. Etc. 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. 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 (POST Clinical / commercial / scientific background). This candidate must have Sponsor, BIotech experience Demonstrated leadership skills Bachelor's degree or equivalent and relevant formal academic / vocational qualification Expectations: This candidate must have strong Project Management skills Must understand pre-clinical drug development activities, CMC, regulatory and commercial activities Translate strategic plans into operational plans, control timelines and finances Strong communication skills are 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.