CEPI (Coalition for Epidemic Preparedness Innovations) · 7 hours ago
Director Clinical Development
United States
Full-time
Remote
Director/ExecutiveCEPI (Coalition for Epidemic Preparedness Innovations) is seeking an experienced and visionary Director of Clinical Development to lead the clinical development strategy for its vaccine portfolio. The role involves providing technical expertise and leadership in clinical investigations, developing strategic partnerships, and supporting disease outbreak responses.
Research
Responsibilities
Establish, maintain (revising as necessary), the overall strategy for the clinical development functional area within CEPI R&D
Oversee and manage the tactical implementation of the clinical development plan, to include maintaining relationships with relevant contract research organisations, other implementing partners, and investigative sites
Manage the clinical development plans of outsourced work from initial feasibility assessment through to project completion, ensuring compliance with SOPs, relevant regulatory regulations (e.g., FDA, EMA, and others), and current ICH GCP guidelines
Contribute to specific vaccine clinical development plans including evaluation of vaccine candidates in outbreak settings, along with evaluation of safety, immunogenicity, and efficacy data resulting from ongoing and completed clinical trials
Ensure that the expected results of clinical trials are clear, measurable, and consistent with CEPI’s policies and mission
Coordination with organisations participating in CEPI’s Clinical Research Preparedness Program
Lead and mentor a multidisciplinary team with accountability for the team’s performance, to include resource management
Management of remote teams and third-party project workers and consultants so that timelines are met and project continuity is maintained
Key clinical development advisor to the Executive Director, Research and Development and CEO
Represent CEPI at international meetings, conferences and forums
Other duties as assigned
Qualification
Required
Medical degree (MD or the equivalent) with extensive experience in clinical development, clinical trials, clinical study plan design, integrated product development/lifecycle management plans in a global setting; industry experience preferred but not required
Internationally recognized clinical expert with demonstrated history of productive engagements with relevant external partners and investigators
Demonstrated personnel leadership and management skills at a senior management level
Proven ability to work in a fast-paced, international and multidisciplinary environment and operate and adapt successfully in an ambiguous and frequently changing ecosystem
Outstanding technical written, verbal, and interpersonal communications skills with an ability to motivate co-workers and subordinates
Benefits
The opportunity to work together with leading experts on solutions for global challenges
Experience in the international effort on developing vaccines against emerging infectious diseases and accelerating vaccine development response to outbreaks
A diverse and inclusive working environment
Company
CEPI (Coalition for Epidemic Preparedness Innovations)
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need.
Founded in 2017
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Mats Olsen
Access and Private Partnerships | Business Development Senior Manager
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