Welcome to Orano
Helping to meet current and future challenges to preserve our world and build the world of tomorrow while taking care of everyone's health is stimulating for you. For us too. By joining the Orano Group, a leading international player in the nuclear industry, you are in the right place.
Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.
Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.
Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.
Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.
Job description
General Summary:
The Sr. Clinical Scientist will be responsible for designing clinical trials, contributing to data cleaning and analysis, contributing to regulatory submissions, collaborating with internal and external stakeholders, and providing scientific leadership.
Job Duties and Responsibilities:
- Design clinical trials: Propose and ensure study designs are scientifically sound, feasible, and aligned with the clinical development strategy and any applicable regulatory requirements, advice and / or guidance. This includes defining eligibility criteria, selecting appropriate endpoints, and ensuring assessments are adequate to capture necessary data in support of endpoints.
- Author and/or contribute to clinical documents: Author clinical study protocols, contribute to clinical trial training materials (e.g Site Initiation Visit Slides), development of informed consent form and other patient materials, case report forms (CRFs) design, statistical analysis plans (SAPs) and clinical study reports (CSRs).
- Data Collection and analysis: Collaborate with clinical operations, biostatistics and data management teams to clean and analyze clinical trial data, interpret results, and prepare clinical study reports.
- Regulatory Submissions: Contribute to the preparation of regulatory documents, including Investigational New Drug (IND) applications, Investigator’s Brochures (IBs), and New Drug Applications (NDAs).
- Stakeholder Collaboration: Liaise with internal and external stakeholders, including investigators, key opinion leaders (KOLs), and regulatory authorities.
- Scientific Communication: May present clinical data and development plans to internal teams, external partners, and at scientific conferences.
- Medical Monitoring: May provide support for medical monitoring activities and/or serve as Medical Monitor for assigned trials.
Our Full-Time Benefits
- Competitive compensation
- Health, Dental, and Vision insurance – with generous employer contributions
- 401(k) with employer matching and contribution amounts
- Life insurance and Short- and Long-Term Disability insurance provided by the company
- Generous Paid Time Off and holiday schedules
- Numerous Training and Development opportunities
- and more…
Ideal qualifications
All candidates must meet the following minimum requirements in order to be considered for this opportunity.
Minimum Qualifications:
- MD or equivalent degree required.
- Minimum of 7-9 years of relevant clinical trial / clinical development experience within the pharmaceutical or biotechnology industry.
- Demonstrated experience designing clinical trials and supporting study reporting (data reviews / cleaning, study report writing).
- Experience with regulatory submissions and interactions with health authorities.
- Experience in oncology and radioligand therapy is required.
Differentiating Qualifications:
- A strong track record of scientific publications and presentations is desirable.
- Experience working on / writing clinical sections of submissions for approval.
- Prior experience with dosimetry studies and / or radioligand therapy PK.
- Prior experience in a start-up environment.
Skills and Knowledge Required:
- In-depth knowledge of clinical trial design and analysis for Phase 1 – 3 trials.
- Familiarity with regulatory requirements and guidelines (e.g., FDA, EMA) for drug development.
- Strong analytical and problem-solving skills with the ability to interpret complex clinical data. Familiarity with data cleaning and query writing. In-depth understanding of RECIST V1.1.
- Excellent written and verbal communication skills, with the ability to present data and concepts clearly and concisely.
- High attention to detail with a commitment to accuracy and quality.
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.
Orano Med
Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.
Find out more about Orano Med
Find out more about Orano Med
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