The Foundation for the National Institutes of Health (FNIH) is seeking a full-time Clinical Operations Manager to help manage a large, multidrug Phase II-III oncology trial under a public-private partnership managed by FNIH that includes participation by the National Cancer Institute (NCI) and its Cooperative trials management group, the Southwest Oncology Group (SWOG); the Food and Drug Administration (FDA); the biopharmaceutical industry, and non-profit patient advocacy groups.
The Clinical Operations Manager will report to the FNIH Cancer Program Manager, will directly support the trial's Principal Investigators and will work collaboratively with project management staff at SWOG to ensure both the strategic and the operational success of the trial. This is a high level management position that also involves liaising with the government and private sector partners in the trial. The position will be based in FNIH's Bethesda, Maryland offices, but will require extensive U.S. travel (e.g., San Antonio, Houston, New Haven) for meetings related to this project.
- Works closely with the trial's Principal Investigators in maintaining the appropriate scientific and strategic direction of the trial, including drug and biomarker selection, trial amendments, and managing relationships among investigators, including running regional investigator meetings.
- Provides project management support for NCI and FDA filings, and related issues, working among the stakeholders.
- Works collaboratively with the SWOG Project Manager to ensure smooth and successful execution of the trial, including accrual, data management, safety reporting, sample and assay processes, human subjects issues, etc.
- Interacts directly with the sites where requested, including telephone contact with site Principal Investigators and Clinical Research Associates to assess and troubleshoot site activation and accrual issues.
- Tracks project timelines and the overall trial budget, particularly with respect to collection and distribution of private sector funds contributed to the trial through the FNIH.
- Facilitates meetings and interacts with the clinical project team to identify issues that might delay the project, and makes recommendations about how most efficiently to achieve project completion.
- Supports the Trial Oversight Committee and public-private partners to provide communication on trial progress and issues and insure satisfaction of all stakeholders in the conduct of the trial.
- Provides organizational support for webinars, educational meetings and conferences related to this or future protocols.
Work requires a Master's Degree or higher (PhD preferred) in biomedical science or a related field and at least five years' experience in clinical trial project management; or any equivalent combination of education and experience that provides the following knowledge, abilities and skills:
- Knowledge of clinical trials logistics and policies, with 3+ years of experience managing clinical trials in a pharmaceutical company (or CRO on behalf of a company), or NCI cooperative group.
- Experience with and knowledge of oncology clinical trials a plus
- Experience in working collaboratively with professionals from diverse sectors (government, academia, and/or private industry);
- Superior interpersonal and communications skills
- Ability to multitask, including working across complex projects;
- Ability to learn quickly, make difficult decisions independently in order to meet tight deadlines;
- Attention to detail;
- Ability to conduct succinct presentations;
- Strong analytical and organizational skills;
- Ability to demonstrate diplomacy as well as initiative when working with others.
LICENSES, CERTIFICATION AND OTHER REQUIREMENTS
Fully paid medical and life insurance, 11 paid holidays, fully paid short-term and long-term disability insurance, and a generous 403(b) retirement plan. Salary is competitive and commensurate with experience.
The FNIH is an equal opportunity employer and does not condone or tolerate discrimination based on race, color, religion, sex, national origin, age, physical or mental disability, or sexual orientation.
The Foundation employs only United States citizens and those non-U.S. citizens authorized to work in the United States in compliance with the Immigration Reform and Control Act of 1986.
How to Apply
Email your cover letter, resume, three references and your salary requirements to Subject: Scientific Program Manager, Cancer at firstname.lastname@example.org.