Flexion Therapeutics Burlington , NC 27215
Sound good so far? It really is!
We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.
Our values focus, ingenuity, tenacity, transparency and fun form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.
Join our team as a VP, Clinical Operations and provide amazing leadership to a growing company. This is a great opportunity to make an immediate impact and work at one of the Boston Globe's Top Places to Work 2017 and Boston Business Journal's Best Places to Work 2017!
Reporting to the Chief Medical Officer, the Vice President Clinical Operations is responsible for shaping Flexion's strategic direction as well as participating in key operational decisions. This will include the design of clinical development plans, in partnership with Clinical Research, from study concept through execution, data collection/analysis and final reporting in compliance with applicable standard operating procedures, regulatory and medical standards.
The Opportunities are Endless!
Serve as a key leader in the organization and work across the organization to provide clinical development insights across the cross-functional teams
Build and maintain a clinical development team with line management of Clinical Operations, Data Management, Biostatistics and Medical Writing staff or set strategic decision to outsource certain responsibilities
Direct the development of clinical plans consistent with program objectives
Oversee the management of CRO relationships
Oversee the preparation of clinical documents, including protocols, IBs, clinical study reports, presentation of key clinical findings to internal and external constituents and clinical components of regulatory documents
Contribute in an active and ongoing manner to the scientific, clinical and commercial development of current and future products.
Ensure scientific and strategic integrity of all biostatistics deliverables
Employ innovative trial designs & statistical methodologies in the design of efficient and effective clinical trials while ensuring scientific and strategic integrity of deliverables
Identify and provide solutions to statistical issues and data analysis related to overall clinical trials & regulatory submissions
Support analysis and assembly of data for a variety of regulatory activities and publications
Oversee clinical development activities (timelines, resource planning, budget/forecast and deliverables related to clinical development projects)
Collaborate with Finance Department to develop budgets and financial projections, and monitor expenditures for the departments within Clinical Development
Communicate Clinical Development progress and issues to senior management and external parties as needed
Ensure departmental compliance with SOPs, GCP and regulatory requirements
Continue to evaluate new initiatives for the department to operate more efficiently including the development of new SOPs
Help build and maintain a highly-functional, lean, and efficient Clinical Development organization including organizational roadmap, hiring/developing new team members, and shaping the organization's culture around the world, including the assessment of new opportunities
Travel as necessary (- 10%) General Administrative
Requires a BA/BS, BSN, or related degree
Requires at least 15 years relevant clinical experience, with at least 5 years in clinical project management
Technical expertise in and/or understanding of cross-function clinical trials processes from study start-up through study closure (e.g., clinical operations, data management, safety, biostatistics, medical writing)
Working, in-depth knowledge of industry standards including ICH guidelines, GCPs and the CFR
Strong leadership and management skills, excellent teamwork and collaboration skills
Demonstrated, effective project management skills
Ability to assess complex issues and identify creative, practical solutions
Demonstrated success in meeting project timelines and budgets
Demonstrated success in identifying, negotiating and overseeing outsourced services and vendors
Ability to foster effective relationships with vendors, investigators, consultants and colleagues
Demonstrated ability to work independently, as well as in a team environment
Excellent communication, writing and presentation skills
International experience a plus
Thank you for taking the time to learn more about us. If this is something that sounds interesting, we'd love for you to apply below.