Orano Med:

Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.

Job Description:

Orano Med is seeking a Senior Director, Clinical Operations to lead the Clinical Operations team.

The Primary duties and responsibilities of the Senior Director, Clinical Operations include including but are not limited to:

• Anticipate project requirements and institute appropriate actions to ensure timelines and project goals are met.
• Oversight of designated activities outsourced to CROs, external consultants, central and specialist labs and other vendors.
• Participates in developing and drafting protocols, amendments, CRF, informed consent forms, Investigator Brochures, annual progress reports, clinical study reports and other documents as needed or requested.
• Review required clinical documents.
• Responsible for the development of, and the oversight for, clinical study milestones to support program objectives.
• Oversee study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation for domestic and international clinical studies.
• Ensures that clinical studies are properly resourced, managed, and executed following the study plan and in accordance with established timelines and quality standards.
• Provides high level oversight of clinical study data, i.e., flow from the sites (CRF completion) to data entry (data entered into database) to data listings/tables/figures.
• Ensures that clinical studies follow guidelines and necessary processes and procedures, as applicable (e.g., Code of Federal Regulations, ICH Guidelines and Good Clinical Practices, FDA, EMA, PMDA) and appropriate industry standards.
• Develops work processes or fosters an environment that enhances the cross-functional effectiveness of clinical operations with other functions such as biostatistics, data management, CMC, medical writing, regulatory, finance, and legal, whether these functions are internal or external to Orano Med
• Ensures audit readiness at all times.
• Ensures adherence to vendor/partner scopes of work, including timelines and budgets, while providing insight and guidance around potential study changes to ensure efficiency and mitigate against fluctuating study costs or study delays.
• Creates a positive and productive work environment for attracting and retaining highly qualified clinical professionals.
• Perform other duties as assigned by management.

All candidates must meet the following minimum requirements in order to be considered for this opportunity. 

• Bachelor’s Degree, science related degree preferred
• Pharmaceutical, biotechnology, or clinical research experience for a minimum of 12 years, among which, more than 6 years are in Pharmaceutical and Biotechnology industry including demonstrated skills and competency in monitoring and clinical project management tasks.
• Thorough knowledge of ICH Guidelines, GCP and the clinical trial process.
• International clinical trial management experience.
• Insight of study budget process including vendor and Investigator agreements and contracts, CRO budgets, invoicing and payments, site budgets and payment administration.
• Experience with clinical protocol design, clinical trial operations, clinical trial bio-specimen logistics, and vendor interactions.
• Demonstrated ability to think strategically and creatively while contributing to multiple projects.
• Ability to manage clinical projects with minimum supervision.
• Ability to train / supervise and mentor junior staff.

Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.