Sr. Manager/Associate Director, Clinical Trial Supplies

 

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. In the U.S., KalVista markets EKTERLY^®, the first and only oral on-demand treatment for hereditary angioedema (HAE). The Company has multiple regulatory applications under review in key global markets.

For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram.

About Sebetralstat

Sebetralstat is a novel plasma kallikrein inhibitor approved in the United States and United Kingdom for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. It is the first and only oral on-demand treatment for HAE. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, sebetralstat has the potential to become the foundational therapy for HAE management worldwide.

 

About the role:

The Sr. Manager/Associate Director, Clinical Trial Supplies will provide technical and strategic input regarding the clinical supply of Investigational Medicinal Product (IMP) to the KalVista clinical development and EAP programs. In this critical role, you will work with external Contract Development Manufacturing organizations (CDMOs) to supply IMP in a timely and cost-efficient manner.

 

Responsibilities:

• Manage end to end Clinical supply with a focus on Global Clinical programs including EAP
• Develop global distribution plans, including depot inventory management, site seeding and supply strategy with appropriate lead time, expiry dates, and replenishment quantities via IRT or manually
• Partner with Clinical and CMC Teams as the Supply Chain point person to ensure that primary and secondary packaging are suitable for the clinical trial design
• Manage CDMOs to provide IMP on time and to budget in support of KalVista clinical development program
• Author, review and/or approve related clinical and technical documents, including label text, master batch records, clinical trial protocols, pharmacy manuals, INDs, IMPDs, etc
• Initiate / support quality events such as deviations and investigations by providing technical expertise and process impact evaluations as needed
• Provide input to project teams on all aspects associated with packaging, labelling, release and distribution of IMP
• Produce, review / approve User Requirement Specification (URS) and User Acceptance Testing (UAT) documentation for IRT systems for randomization and allocation of IMP to clinical trials subjects
• Collaborate with Finance to reconcile plan vs. actual budget based on purchase orders and invoices
• Lead key process optimization initiatives as needed while partnering with cross-functional teams for support
• Ensure eTMF is always up to date for trials
• Work in accordance with KalVista’s SOPs and

 

Qualifications:

• Pharmacy, chemistry or equivalent background. Alternatively, experience in managing clinical Supply Chain trials
• Trained in GMP (GCP)
• Demonstrated experience in global clinical trial supplies, ideally including the EU
• Ability to work independently and cross functionally/culturally in a fast-paced environment. Strong accountability and flexibility required.
• 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 – 3 days per week in office

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Important Notice to Third-Party Recruiters & Staffing Agencies:

The current job openings advertised on this website are for the sole purpose of candidates to apply directly. Unsolicited and anonymous CVs submitted in any manner to KalVista employees, including to employee personal e-mail accounts, are considered to be the property of KalVista and will not qualify for a fee to be paid. Referral fees will only be payable where KalVista has agreed with an agency to work on a specific appointment, and then only in conjunction with a fully-executed contract for service.

If any Agency representative contacts a KalVista Hiring Manager or company employee, other than a member of the KalVista Talent Acquisition team, to solicit an appointment to engage on a job opening, that Agency will not be considered for that specific job opening or future opportunities with KalVista.

Thank you for your understanding and cooperation.