Clinical Supply Program Manager

Clinical Supply Program Manager

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This is a full-time salaried position: Monday – Friday, 1st shift.
 

Demand Led and Decentralised Trial Supply are two of the most exciting clinical trial supply innovations in recent times.  Catalent is at the forefront of both advancements within the industry, and the Clinical Supply Program Manager is central to our continued success.

The Clinical Supply Program Manager will be a key member of the Strategic Supply Solutions team, scoping, planning and leading the continued development of these initiatives. You will have significant input in continuous improvement, designing processes, contributing to SOP preparation and technology solutions.

The Clinical Supply Program Manager has overall responsibility and accountability for providing Global Leadership and proactive Client Relationship management to a client or group of clients as appropriate ensuring appropriate communication, business engagement, implementation and service delivery to enable retention, growth and long term mutual business partnership. This will be achieved through leading global teams comprised of Global Project Managers and Project Managers across Demand-Led and Direct To Patient trials.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Work with Director and other SMEs to gain a thorough understanding of Decentralized Trials, Direct to Patient shipping requirements, Site to Patient, DCT technologies, and industry trends; become an SME capable of training others, while staying current with trends and customer needs

• Work with Director to manage DCT activities for new opportunities to achieve sales and new business goals from identification through contract award

• Work with Project Managers to set up projects for success and act as point of escalation for all DTP and DCT related activities once in execution mode. Provide project oversight and solutioning, as needed

• Work with Director to expand DTP and DCT services in Europe and ROW - audits of partners, process mapping and SOP creation. Train internal teams on capabilities and process

• Work with PM and BD to respond to customer inquiries and requests for information from both internal and external customers in a timely manner

• Lead the identification, development, implementation and control of Continuous Improvement activities required by the Program

• Develop, maintain and train Global SOPs relating to DLS Program and Project Management

• 25% travel expectations (global)

• Other duties as assigned

The Candidate:

• Bachelor's degree in Science or related discipline with 2+ years of relevant experience, preferred

• High school diploma or equivalent with 8+ years of relevant experience, required

• Pharmaceutical experience, required 

• In depth understanding of clinical trials and other business services

• Thorough knowledge of GMP

• Good knowledge of drug development process and GCP requirements in clinical development

• Proficiency with MS Office Programs, including MS Project, WorkFront

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

Why You Should Join Catalent:

• Defined career path and annual performance review and feedback process 

• Diverse, inclusive culture 

• 152 hours of PTO + 8 paid