Employment Classification : Regular/Permanent
Job details :
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.

N/A
Adress : Indianapolis, Indiana