Vertex Pharmaceuticals
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Cambridge,
MA
This leadership role will be responsible for heading up the newly formed Global Trial Activation Group (GTAG) at Vertex Pharmaceuticals. The Director will be to define a long term strategy and scope for this group and develop a plan to build to that vision. The mission of the Global Trial Activation Group is to oversee and manage clinical trial site activation inclusive of study start-up strategies and clinical documentation within a rapidly changing global environment. The primary objectives of GTAG include: improving current best practices for site activation approval, compressing site activation timelines, and developing new opportunities for partnerships with sites, CROs and other Vertex departments across the global development portfolio.
This role is additionally focused on strategically working across Clinical Development Operations to support the facilitation of evidence-based planning for the successful implementation and conduct of global clinical trials inclusive of country selection, site identification, and investigator (regulatory) document management. He/she will partner with management to identify and prioritize initiatives related to the optimization of all study start-up activities.
Key Responsibilities:
* Oversees global clinical trial activation leveraging internal and external resources, develops best practices
* Develops performance metrics and targets for study activation, and ensures continuous improvement in processes to support department and company goals around study start-up
* Work within Vertex to define roles and responsibilities and implement with a sustainable, consistent methodology.
* Works closely with key departments to ensure exchange of information, knowledge, and deliverables. Some departments to include:
* Clinical Operations – Country and Site Selection criteria, Site Activation Timelines, ICF development
* Regulatory - Harmonization of Clinical Trial Applications and EC/IRB submissions, documents for Clinical Trial Applications
* Site Agreements Group- Harmonization of timing of full IRB approval and executed Clinical Trial Agreement, compensation for injury, subject stipends, reimbursement language
* Responsible for Resource Planning and Procurement:
o Recruit, align and integrate internal staffing headcount to meet the business needs
o Define resource needs and sourcing strategy based on expected fluctuations in workload
o Adopt effective strategies with other departments to leverage shared resource model when possible
* Responsible for Training and Staff Development
* Build department in people and expertise to accomplish mission
* Ensure proper training for all staff members
* Provide career development opportunities for staff members where possible
Minimum Requirements
Minimum Requirements:
· Bachelor’s degree required, advanced degree preferred ,with 7+ years of relevant industry experience
· Extensive experience strategizing and implementing global study execution activities
· Excellent verbal and written communication skills, superb oral presentation skills
· Ability to thrive in a fast-paced, evolving environment with experience in a matrix organization
· Solid working knowledge of ICH/GCP guidelines
· Successful track record managing direct reports and contractors
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain
Cambridge, MA
Cambridge, Massachusetts
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