About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of novel medicines for diseases with significant unmet need. KalVista announced positive phase 3 data from the KONFIDENT trial for its oral, on-demand therapy, sebetralstat for HAE in February 2024. The Company’s NDA for sebetralstat has been accepted by the FDA with a PDUFA goal date of June 17, 2025. KalVista also filed an MAA with the EMA in July 2024 and expects to file for approval in the UK, Japan, and other countries later in 2024.
For more information about KalVista, please visit www.kalvista.com or follow on social media at @KalVista and LinkedIn.
About the Role:
The Sr. Manager / Associate Director, Clinical Supplies will provide technical and strategic input regarding the clinical supply of Investigational Medicinal Product (IMP) to the KalVista clinical development program. In this critical role, you will work with external contract clinical supplies organizations (CTSOs) to supply IMP in a timely and cost-efficient manner.
Responsibilities:
- Develop clinical supply strategy in conjunction with Clinical Team
- Work with the Clinical and Regulatory Teams to ensure that the label texts for each territory involved in a clinical trial meet requirement
- Work with the Clinical and CMC Teams to ensure that the primary and secondary packaging are suitable for both the clinical trial design and the local climate
- Lead the development and implementation of Interactive Response Technology (IRT) systems
- Lead the selection of and work with external clinical trials supply organizations (CTSOs) and consultants to support KalVista clinical development program
- Ensure that appropriate quality standards are maintained
- Provide input to project teams on all aspects associated with packaging, labelling, release and distribution of IMP
- Manage CTSOs to provide IMP on time and to budget in support of KalVista clinical development program
- Produce, review and approve User Requirement Specification (URS) and User Acceptance Testing (UAT) documentation for IRT systems for randomization and allocation of IMP to clinical trials subjects
- Manage UAT on IRT systems
- Work in accordance with KalVista’s SOPs and Policies
Requirements:
- Pharmacy, chemistry or equivalent background. Alternatively, experience in Supply Chain
- Trained in GMP (GCP)
- Demonstrated experience in global clinical trial supplies, ideally including the EU
- Demonstrated experience managing external contract packaging, labelling and distribution organizations
- Demonstrated experience of the setup and use of IRT systems to control IMP assignment to patients and for supply-chain management
- Experience supporting Early Access Programs (EAP) a plus
- Bachelor’s Degree required.
- Hybrid Role – 2 days per week in office
KalVista is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
#J-18808-Ljbffr
