FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research and technology — creating a unique mix of capabilities to address today’s interrelated development challenges. FHI 360 serves more than 70 countries and all U.S. states and territories. We are currently seeking qualified candidates for the position of: Associate Director, Clinical Research
Description:
The Associate Director (AD), Clinical Operations is responsible for the cross-functional coordination and alignment of clinical research programs for the Contraceptive Technology Innovation Department, ranging from preclinical through Phase III. Works with teams to ensure compliance with all relevant regulations and guidelines to achieve strategic and operational departmental objectives. Serves as a lead for clinical operations policies and procedures as well as for regulatory authority requirements and guidelines, including but not limited to those pertaining to the International Conference on Harmonization (ICH).
Job Summary / Responsibilities:
- Provide Clinical Research operations expertise and leadership to cross functional project teams.
- Serve as an interface between senior department leadership on clinical research operations.
- Ensure that clinical projects are conducted in compliance with all relevant regulations and guidelines associated with USFDA, EMA, and other regulatory organizations.
- Develop and maintain department-specific work instructions related to regulatory processes.
- May conduct or assist other regulatory staff in the conduct of quality control visits to external service providers and investigational sites to assure regulatory compliance.
- Work closely with internal project and regulatory teams to determine whether project-specific clinical needs require additional external support.
- Coordinate cross-program activities and provide regulatory guidance across the full spectrum of clinical product development from preclinical through Phase III.
- Author and contribute to scientific publications and presentations.
- Develops and maintains strong business relationships with sponsors and key opinion leaders.
Qualifications:
- Bachelor’s Degree or its international equivalent in Biology, Chemistry, Clinical Trials, Life Science, Social Sciences, or a related field.
- At least 10 years’ experience in clinical development gained in a pharmaceutical, biotechnology, or clinical research organization; or an equivalent combination of relevant education and/or experience sufficient to successfully perform the key responsibilities of the job.
- At least 5 years’ management experience.
- Working knowledge of clinical research regulations and guidance in US, Europe and other international territories.
- Excellent knowledge of the drug development process from pre-CTA/IND status through to post approval marketing studies.
- Prior experience in an international non-governmental organization (NGO) or government research agency highly desirable.
- Prior experience working in contraceptive research highly desirable.
- RAC certification preferred.
- Working knowledge of global regulatory requirements for clinical research, including USFDA and EMA.
- Ability to think strategically and creatively to identify novel regulatory strategies for international clinical research studies.
- Proven ability to work in a team environment, providing technical expertise and leadership to cross functional project teams.
- Able to plan and organize efficiently by adhering to existing processes and procedures and by maximizing the use of available internal and external resources.
- Well-developed oral and written communication skills.
- Excellent presentation skills.
- Travel Requirements: Less than 10%
This job description 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.
We offer competitive compensation and an outstanding benefit package. Please click here to visit FHI 360’s Career Center for a list of all open positions.
FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment 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, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.
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