Director, Clinical Supply Chain

Regular/Permanent
USA

Remote Options

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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.

Job description

General Summary:

The Director of Clinical Supply will be responsible for overseeing the planning, coordination, and management of clinical trial materials and supplies. This role requires a strategic thinker with strong leadership skills, who can ensure the efficient and timely delivery of clinical supplies to support our clinical development programs.

Job Duties and Responsibilities:

Strategic Planning and Management:

Develop and implement clinical supply strategies to support clinical trial timelines and objectives.
Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs and CMC, to ensure alignment on clinical supply needs and priorities.
Oversee the demand forecasting and supply planning, for clinical trial drugs.

Operationalization and Oversight:

Manage the procurement, packaging, labeling, and distribution of clinical trial comparator products.
Ensure compliance with all regulatory requirements and Good Manufacturing Practices (GMP) standards.
Oversee the selection and management of third-party vendors and contract manufacturing organizations (CMOs) involved in the clinical supply chain.
Create applicable trial documentation (e.g. pharmacy manual, labels) with input from relevant functions.
Set-up and oversight of Interactive Response Technology (IRT) platforms used on clinical trials.
Ensure timely and accurate financial reporting and forecasting related to clinical supplies.

Quality and Compliance:

Implement and maintain robust quality systems and processes to ensure the integrity and quality of clinical trial materials.
Ensure compliance with all applicable regulatory guidelines, including FDA, EMA, and ICH guidelines.
Lead the investigation and resolution of any quality issues related to clinical supplies.

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

Minimum Qualifications:

Bachelor's degree in a relevant field (e.g., Supply Chain Management, Pharmacy, Life Sciences). Advanced degree (e.g., MBA, PharmD) preferred.
Minimum of 10 years of experience in clinical supply chain management within the pharmaceutical or biotechnology clinical trial industry.
Demonstrated experience in managing the end-to-end clinical supply chain for multiple global clinical trials.
Proven track record of success in a leadership role within a start-up environment.
Experience with regulatory submissions and inspections related to clinical supplies is a plus.

Differentiating Qualifications:

Prior experience with radiopharmaceuticals strongly preferred.

Skills and Knowledge Required:

Strong understanding of clinical trial supply chain management and logistics within the (radio)pharmaceutical industry.
In-depth knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and regulatory requirements for clinical supplies.
Strong project management skills, with the ability to manage multiple projects and priorities simultaneously.
Excellent problem-solving and decision-making skills, with a strategic and analytical mindset.
Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
Proficiency in supply chain management and IRT software and tools.

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.

Director, Clinical Supply Chain

Ref: 2024-17822

Regular/Permanent

Indianapolis, Indiana

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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