Manager - Clinical Supplies

Sun Pharmaceutical Industries, Inc.; Mumbai; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd is seeking a Global Clinical Supply Chain professional to lead operations for one or more clinical studies. You will manage IP supply from protocol input to close-out and ensure supply is not on the critical path, while coordinating with clinical study teams.

You will develop IP demand and supply plans, manage depot inventory, packaging, IRT contracts, and ensure timely delivery to patients in line with GxP and TMF requirements. Minimal travel expected.

Qualifications

• University degree in life sciences, pharmacy, logistics, engineering or related field.
• Minimum 3 years' experience in clinical supply management, clinical operations or logistics for clinical trials.

Responsibilities

• Lead operational supply set-up and follow-up for one or more clinical studies, from protocol input through to study close-out and reconciliation, ensuring investigational product supply is not on the critical path.
• Serve as the primary supply chain interface with the clinical study team (Global Study Manager/Lead, Local Delivery Lead, Quality…), following STOM principles and supporting asset-level supply strategy in partnership with the Clinical Manufacturing and Supply Chain (CMSC) Workstream Lead.
• Review and challenge clinical protocols with respect to IP supply, ensuring supply feasibility, identifying constraints, and agreeing supply options and risks with study teams before study initiation.
• Develop, implement and maintain IP demand and supply plans for each assigned study, modelling demand from patient enrolment forecasts, treatment regimens, duration and protocol design, and keeping plans up to date as studies progress.
• Define and manage depot and pack site inventory policies and collaborate with worldwide depots to meet in-country requirements, including management of IP expiry, extensions, replenishment and destruction strategies.
• Ensure label content and data are defined in the appropriate systems; liaise with labelling and packaging experts on pack design and components; and ensure appropriate IRT contracts and study set-up are in place, including packing and distribution strategies and IVRS/IWRS specifications as applicable.
• Execute supply plans to deliver on published study milestones with consistent, on-time, compliant delivery to patients, while minimising waste and ensuring timely communication and escalation of supply issues.
• Lead complex problem solving across technical, quality, regulatory and operational dimensions without compromising quality, cost or delivery, maintaining appropriate documentation in accordance with GxP and the Trial Master File (TMF).
• Monitor study KPIs, identify trends and implement corrective and preventive actions, contributing to continuous improvement of supply chain processes and ways of working.
• Oversee externalised supply chain activities by creating study-specific technical agreements, providing inputs to vendor proposals and proactively identifying and resolving obstacles with external partners.

Education

University degree in life sciences, pharmacy, logistics, engineering or related field

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Global Clinical Supply Chain

Business Unit:

Global External Manufacturing and Supply Chain - Biologics

Job Grade

Location :

At Sun Pharma, we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys".

Key responsibilities:

• Lead operational supply set-up and follow-up for one or more clinical studies, from protocol input through to study close-out and reconciliation, ensuring investigational product supply is not on the critical path.
• Serve as the primary supply chain interface with the clinical study team (Global Study Manager/Lead, Local Delivery Lead, Quality…), following STOM principles and supporting asset-level supply strategy in partnership with the Clinical Manufacturing and Supply Chain (CMSC) Workstream Lead.
• Review and challenge clinical protocols with respect to IP supply, ensuring supply feasibility, identifying constraints, and agreeing supply options and risks with study teams before study initiation.
• Develop, implement and maintain IP demand and supply plans for each assigned study, modelling demand from patient enrolment forecasts, treatment regimens, duration and protocol design, and keeping plans up to date as studies progress.
• Define and manage depot and pack site inventory policies and collaborate with worldwide depots to meet in-country requirements, including management of IP expiry, extensions, replenishment and destruction strategies.
• Ensure label content and data are defined in the appropriate systems; liaise with labelling and packaging experts on pack design and components; and ensure appropriate IRT contracts and study set-up are in place, including packing and distribution strategies and IVRS/IWRS specifications as applicable.
• Execute supply plans to deliver on published study milestones with consistent, on-time, compliant delivery to patients, while minimising waste and ensuring timely communication and escalation of supply issues.
• Lead complex problem solving across technical, quality, regulatory and operational dimensions without compromising quality, cost or delivery, maintaining appropriate documentation in accordance with GxP and the Trial Master File (TMF).
• Monitor study KPIs, identify trends and implement corrective and preventive actions, contributing to continuous improvement of supply chain processes and ways of working.
• Oversee externalised supply chain activities by creating study-specific technical agreements, providing inputs to vendor proposals and proactively identifying and resolving obstacles with external partners.

Minimal travel

Job Requirements

Educational Qualification

University degree in life sciences, pharmacy, logistics, engineering or related field.

Experience

Minimum 3 years' experience in clinical supply management, clinical operations or logistics for clinical trials.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).