Summary of the Position:

The Director of Government Programs will provide administrative oversight and management of large USG (United States 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:

1. 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.

2. Identifies resource needs, scalability of operations, and participates in recruitment to ensure selection and hiring of qualified staff.

3. Expertise with the financial management of large, cross-functional budgets.

4. Experienced working within financial and operational reporting requirements of the USG and other funding agencies.

5. Supports and works with staff and Client Solutions 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 and establishing a relationship with client medical and scientific experts. Supports responses to Request for Proposals (RFPs) and RFIs (Information), providing input that showcases expertise in the op technical aspects of clinical trials.

6. Makes independent decisions that represent the core business.

7. Partners with other functional areas for the successful implementation and execution of clinical studies:

7.1 Provides operational expertise in the management, coordinating and oversight of the specific program or projects.

7.2 Provides operational expertise for selection of investigators and vendors.

8. Interprets and presents operational metrics both internally and externally.

9. Builds strong relationships with internal and external subject matter experts.

10. May provide guidance and oversight to direct report(s) including the management of workload, special projects, performance management, salary review, and career development.

11. 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.
• Knowledge of industry-standard Clinical Development IT solutions such as EDC, CTMS, ETMF
• 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 or its international equivalent, 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 USG and NGO funded programs
• Preferences: Advanced degree (business or technical) preferred.
• Special Position Requirements: Multi-lingual expertise preferred.

Physical Expectations:

• Typical office/virtual environment.
• Ability to sit or stand for extended periods of time.
• Ability to move 5-15 lbs. or 2.26 – 6.8kg.

Travel Requirements:

• Expected travel time is up to 25% for this position. The role requires international travel as needed to support business needs.

Pay Equity and Benefits:

The anticipated salary range for this role is listed below. FHI Clinical’spay ranges represent national averages that vary by geographic location. When determining an offer amount, FHI Clinical factors in multiple considerations, including but not limited to: relevant years of experience and education possessed by the applicant, base salary of internal peers, and business sector and budget.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.

FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

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