Assoc Director, Clinical Project Manager & Drug Development– FSP
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Job Location:
Cambridge, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
AD Project Management/Senior Project Manager Drug Development
At Thermo Fisher Scientific youll 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 yourelooking for a place where your work in partnership with others can have real impactand where youre encouraged to challengeyourself and contribute to breakthrough solutions this rolecould be a great fit.
Discover Impactful Work:
This individual will be leading the projects 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. this particular role this candidate will also be responsible for any high level plans & progress from pre-clinical into 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
- Bachelors 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.
Required Experience:
Director
Key Skills
- Business Development
- Project Management
- Process Management
- Product Management
- Autocad
- Project Management Software
- Microsoft Project
- Customer relationship management
- Budgeting
- Product Development
- Project Implementation
- Google Suite
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
