Summary of the Position:
The Director, Government Programs will provide administrative oversight and management of large government or NGO-sponsored research programs. The position requires expert and detailed knowledge of international collaborations in clinical research and an in-depth understanding of the best practices and procedures involved in the execution thereof.
Essential Functions:
May serve as project director for clinical trials; oversees large, diverse, multi-country project operations to ensure clinical trials are performed on schedule, within budget and meet all quality and regulatory requirements.
Identifies resource needs, scalability of operations, and participates in recruitment to ensure selection and hiring of qualified staff.
Expertise with the financial management of large, cross-functional budgets.
Experienced working within financial and operational reporting requirement of the US government and other funding agencies.
Supports and works with staff and Business Development to provide expertise and support in the development of new business with potential clients and in building and retaining relationships with current clients. Support will consist of but not be limited to participation in bid defenses and capabilities meetings, establishing a relationship with client medical and scientific experts, identifying new areas of research and providing internal training of personnel on emergent developments in clinical research. Supports responses to Request for Proposals (RFPs) and RFIs (Information), providing input that showcases expertise in the scientific and technical aspects of clinical trials.
Makes independent decisions that represent the core business.
Builds relationships with clients by working/meeting/consulting with clients on study protocol development and help answer relevant queries from regulatory authorities by justifying study design.
Partners with Clinical Operations and other functional areas for the successful implementation and execution of clinical studies:
Provides operational expertise for selection of investigators and vendors.
Trains staff, and study site staff on the therapeutic area, investigational product, and/or clinical protocol.
Provides administrative support throughout conduct of a clinical trial; responds to clinical questions from sites, IRBs/IECs, and Health Authorities.
Interprets and presents operational metrics both internally and externally.
Contributes to or performs therapeutic area/indication research and competitor analysis
Builds strong relationships with internal experts.
Attends scientific and industry conventions gives talks/presentations and participates in professional industry groups.
Provides guidance and oversight to direct report(s) including the management of workload, special projects, performance management, salary review, and career development.
All other duties as assigned.
Knowledge, Skills and Abilities:
Experience in global drug development.
Previous participation in a government or agency-sponsored clinical development program is essential, including involvement in all stages of clinical trials
Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing.
High level of communication (written and verbal), interpersonal, organizational, and cross-functional collaboration skills.
Knowledge of GCP and ICH Guidelines.
Experience in infrastructure building in low and middle-income countries.
Flexibility to work with colleagues in a global setting.
Strategic leader with demonstrated success building, managing and developing individuals and teams.
Experience with the development of SOPs and policies.
Knowledge of industry-standard Clinical Development IT solutions.
Executive presence.
Values-based collaborator – respectful, accountable and collaborative.
Ability to relate and work with a wide range of people to achieve results, Appreciation of diversity and multiculturalism.
Impactful written and verbal scientific communication.
Successful and superior influencing skills across all levels of the organization and external collaborators.
Problem-solving and risk-mitigation skills.
Confident, positive attitude, enthusiastic and charismatic.
Strategic and creative thinker.
Ability to build working relations throughout the organization and with business partners to achieve business goals.
Strong financial management skills.
Strong time management and organizational skills.
Ability to manage multiple projects in a fast-paced environment.
Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.
Position Requirements:
Education: Bachelor’s Degree in a scientific discipline or related field of study.
Preferred Job-related Experience: 10+ years of health-related government contracting; 5+ years of supervisory or management experience. Experience working in Africa.
Additional Eligibility Qualifications: Experience and knowledge in infrastructure building including construction, electrical or other trades.
Preferences: Advanced degree (business or technical) preferred. Knowledge of GCP and working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines and the application to the conduct of clinical trials.
Special Position Requirements: Ability to read and speak English proficiently. Multi-lingual expertise preferred.
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