Initiates, directs, and executes all scientific research and/or development strategies in clinical research studies and scientific projects. Investigates the feasibility of applying a wide variety of scientific principles, methods, and concepts to clinical studies, problems, and projects. Plans and executes training/training materials for clinical research studies and internal and external researchers. Makes major contributions to scientific literature and conferences. Acts as spokesperson on corporate research studies and scientific projects and advises executive management. Interfaces with various departments and serves as an internal clinical consultant.
- Develops scientifically appropriate approaches to answering a variety of clinical research questions.
- Provides scientific oversight for implementing, conducting, and managing clinical research studies and proposals.
- Drafts, edits, reviews and presents analysis of clinical research findings and reports for publication.
- Provides in-house review of clinically-relevant sections of the protocols, papers, research strategies and proposals for methodological and technological soundness.
- Serves as a clinical lead for regulatory submissions.
- Develops and improves systems, including manuals or documents that strengthen services and technical assistance efforts.
- Represents technical leadership by speaking, organizing or leading national or international conferences, serves on scientific or technical advisory boards, and gives oral presentations or teaches university course level work.
- Oversee management and budget for one or more clinical research projects.
- Serves as a medical monitor by: 1) contributing to investigator and internal team trainings, 2) assisting in medical review, assessment and interpretation of clinical and safety data and clinically-relevant protocol deviations to ensure accuracy and appropriate medical interpretation, 3) interacting directly with site investigators and study teams in review of safety data, 4) working closely with Medical Monitoring/Safety Management vendors by providing medical review of safety reporting including SAE narratives, pregnancy reports, suspected unexpected serious adverse reactions (SUSAR) reports, investigator brochures (IBs), and other relevant reports.
- As a key member of a cross-functional team (along with CMC, Preclinical, and Regulatory), ensures coordination and integration of clinical activities into product development programs.
Applied Knowledge & Skills:
- Comprehensive knowledge of theories, concepts, and practices used in analysis of scientific projects and clinical research studies.
- Significant experience in all aspects of clinical trial design, execution, data interpretation, and reporting.
- Excellent oral and written communication skills.
- Technical skills, scientific creativity, ability to collaborate with others, and independent thought.
- Project or technical leadership experience.
- Knowledge of GCP, ICH, and global guidelines pertaining to the conduct and reporting of clinical trials.
- Ability to adapt and resolve problems/issues to bring clinical research projects to completion.
- Knowledge and experience in therapeutic areas related to Women’s Health.
- Experience leading and overseeing SRA-regulated clinical trials.
- Experience representing clinical team in larger cross-functional team collaborations.
- An understanding of pharmacovigilance practices for clinical development programs.
Problem Solving & Impact:
- Works on problems that are diverse and complex requiring analysis or interpretation of factors or situation.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Decisions have major impact on the management and operations of an area within a department.
- Serves as the mentor/team lead to other scientists.
- Typically reports to a Director.
- May supervise two or more operational research staff
Doctorate Degree or its International Equivalent • Psychology, Sociology, Anthropology, Public Health, Bio statistics, Medicine or Related Field.
- M.D. (or its international equivalent) strongly preferred.
- Minimum of 8 years of combined relevant experience in various stages of drug development and/or clinical research including study concept, study initiation, implementation, data analysis, publication, and final regulatory submission OR 8-12 years of experience with relevant scientific disciplines developing strategies in clinical research studies and scientific projects.
- Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
- Must be able to read, write, and speak fluent English.
Typical Physical Demands:
- Typical office environment. Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.
Technology to be Used:
- Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, cell phones.
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.
About the Organization
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, technology, communication and social marketing — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.
As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.