Global Medical Development Manager

sandoz; Telangana; On-site; INR 3,000,000 - 5,200,000; Full time

Job summary

Sandoz is seeking a Global Medical Development Manager to lead medical development strategies for assigned products during development. You will oversee study design, evidence generation, regulatory interactions, and safety oversight, integrating medical, clinical, regulatory, and patient safety perspectives.

The role emphasizes high ethics, GCP compliance, collaboration across cross functional teams, external engagement with health authorities, and the preparation of scientific submission

Responsibilities

• Provides medical development input for assigned products and projects, including assessment of preclinical findings, formulation information, device-related considerations, pharmacology, pharmacokinetics, pharmacodynamics, clinical evidence, treatment guidelines, standard of care, regulatory expectations and other relevant medical information.
• Contributes to product- or indication-specific analysis of internal and external data sources to generate medical insights that support formulation, device, therapy and clinical development decisions and increase the probability of successful product development.
• Provides medical and development-phase patient safety input to product development teams and relevant development milestones; where required, provides training to other functions on pharmaceutical and medical topics including indication, posology, pharmacokinetics, pharmacodynamics, efficacy and safety.
• Collaborates with cross-functional partners to support aligned, compliant and timely development deliverables.
• Engages with external experts, Health Authorities and external service providers as required for assigned products or projects, in alignment with project needs and applicable internal processes.
• Represents the medical aspects of Clinical Development & Patient Safety, Generics as a subject matter expert in assigned product-, platform- or process-related initiatives, development forums and interactions with external partners.

Job description

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

The Global Medical Development (GMD) Manager provides medical development expertise and medical supervision for assigned products and projects during the development phase. The role supports pipeline selection, development strategy, clinical development planning, study design, evidence generation, regulatory interactions and key development deliverables by integrating medical, clinical, scientific, regulatory and patient safety perspectives.

The GMD Manager contributes to scientifically justified, patient-focused and efficient development approaches, including lean clinical strategies where appropriate. The position holder serves as a medical and development-phase patient safety knowledge resource for Sandoz products in development, ensuring that decisions are informed by disease understanding, patient needs, treatment guidelines, standard of care, relevant scientific literature, clinical and nonclinical evidence, benefit-risk considerations and applicable regulatory expectations.

The GMD Manager works to high ethical and compliance standards, including GCP and relevant internal and external guidance. The role contributes to the identification, evaluation, communication and mitigation of medical and patient safety risks for assigned development products, with the objective of protecting patients and supporting successful product development and regulatory submissions.

Job Description

Major accountabilities:

Major accountabilities

• Provides medical development input for assigned products and projects, including assessment of preclinical findings, formulation information, device-related considerations, pharmacology, pharmacokinetics, pharmacodynamics, clinical evidence, treatment guidelines, standard of care, regulatory expectations and other relevant medical information. Provides medical expert assessment to support selection and evaluation of new product opportunities, with the aim of enabling scientifically justified, patient-relevant and efficient development strategies, including lean clinical strategies where feasible.
• Contributes to product- or indication-specific analysis of internal and external data sources to generate medical insights that support formulation, device, therapy and clinical development decisions and increase the probability of successful product development. Maintains and updates medical assessments, including efficacy, safety, treatment guidelines and standard of care, to support development optimization and regulatory discussions such as scientific advice, briefing books and paediatric investigation plan-related activities, as applicable.
• Provides medical and development-phase patient safety input to product development teams and relevant development milestones; where required, provides training to other functions on pharmaceutical and medical topics including indication, posology, pharmacokinetics, pharmacodynamics, efficacy and safety. Collaborates with cross-functional partners, including Product Development, Portfolio and Platforms, Global Medical Affairs, Quality, Pharmacovigilance, Regulatory Affairs, BD&L, SDCs, relevant governance forums and external partners, to support aligned, compliant and timely development deliverables.
• Engages with external experts, Health Authorities and external service providers as required for assigned products or projects, in alignment with project needs and applicable internal processes. Provides input to clinical study design, including study population, and contributes medical and patient safety input to scientific and regulatory documents such as investigator brochures, clinical development plans, clinical study protocols, informed consent documents, annual safety reports, DSURs, risk management plans, clinical study reports and key submission documents, as applicable.
• Represents the medical aspects of Clinical Development & Patient Safety, Generics as a subject matter expert in assigned product-, platform- or process-related initiatives, development forums and interactions with external partners, as appropriate. Performs medical monitoring or sponsor medical oversight for clinical studies in patients, where required, according to applicable requirements and assigned responsibilities.
• Provides medical interpretation of clinical endpoint and safety study results for assigned products and projects. Monitors and interpret clinical safety information for development projects and products, including literature review, evaluation of relevant individual cases or line listings, signal-related information, medical evaluation of quality defects, investigator notifications and periodic medical assessments for ethics committee