|Title:||Clinical Program Director - Remote|
|Department:||Global Clinical Development|
|Job Status:||Full-time, Benefited|
Celerion is the is the leading global provider of outsourced clinical research services. Customers include the leading global pharmaceutical companies as well as a biotechnology and small to midsized pharmaceutical companies. Our focus is on the development of innovative pharmaceuticals with the goal of enabling companies to reach early decisions concerning which compounds to progress further into clinical development. Supporting our clinical work are two world class bioanalytical laboratories located in Europe and the US. Celerion is unique from other leading CROs in that our focus is on early phase clinical studies through clinical proof-of-concept, and beyond.
- Early Clinical Research and studies required to support product labeling
- Data Management and Biometrics (modeling and simulation, study design and protocol development, clinical data management, biostatistics, PK/PD, medical writing and reporting)
- Bioanalytical Services (discovery to late stage services with capabilities in small and large drug, metabolite and biomarker molecules)
- Drug Development Services (Regulatory affairs and drug development consultancy)
- Global Clinical Development including project management and monitoring
The main responsibility of the Program Director is operational management. This is achieved by leadership and oversight of one or more of the clinical project teams to accomplish high quality work and ensure sustainable relationships with sponsors on Phase 2 and Phase 3 studies.
This role will be home based anywhere in the United States. Due to our international footprint, schedule flexibility is important. This position will travel roughly 20%-25% to support client meetings and bid defenses. Travel will be primarily in the United States, but could include Europe on an as needed basis.
- Perform project lead and team lead activities; from project/study proposal and budget (pre-contract) to project/study closure within budget
- Manage Study Teams for clinical trials, in adherence to Good Clinical Practice, local and international standards and regulatory requirements
- Responsible for the supervision and the performance of the project/study with regards to the quality standards of Celerion and/or clients wherever applicable
- Responsible for the supervision and the performance of the project team with regards to budget adherence and resource allocation
- Ensure that all assigned projects/studies are managed within to ensure completion on time, in budget and in the highest quality standards
- Act as key contact point, and communicate effectively with Sponsors/Clients, Site Investigators, Vendors, and Contractors
- Oversee internal and external study contracts with investigator study sites, vendors, contractors and sub-contractors in cooperation with Senior Operational Management, and other Celerion departments as applicable (Finance, Contract Management, Quality Assurance)
- Act as mentor for direct reports such as Clinical Project Coordinators (CPC), Clinical Research Associates (CRA), and Clinical Project Managers (CPM); initiate, organize and oversee compliance to training requirements including appropriate documentation
- Represent Celerion at conferences, business development and marketing events
- Foster excellent relationships with opinion leaders and act as an ambassador for Celerion
The Program Director will take a lead role in interfacing with Sponsors/Clients and prospective Sponsors/Clients, providing both technical and business credibility; be responsive to the Sponsor/Client while assuring comprehensive management of projects/studies.
Experience and Qualifications:
- Bachelor’s degree or higher required in a biomedical-related field, life sciences or related field.
- Minimum of 10 years prior experience in clinical research (Pharma or CRO).
- Minimum 5 years of experience working in a Clinical Project Manager / Director capacity.
- 2 years of experience in project scheduling, managing resources, budgets and coordinating team activities is highly preferred.
- Experience in support of business development processes; including budgets, proposals and bid defense planning and execution.
- Knowledge of Good Clinical Practice, 21 CRF Part 11, and other relevant regulatory requirements.
Please visit www.celerion to learn more and to apply.