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:
- 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 committees, wherever required. Contributes to integration, analysis and evaluation of internal and external safety information during product development and supports appropriate communication and mitigation of identified medical or patient safety risks. Supports preparation and delivery of development-phase safety deliverables for assigned products, including DSURs and other required safety documents, ensuring appropriate medical input, quality and timeliness within assigned responsibilities. Provides medical input into responses to Health Authority inquiries for development projects and products, including safety-related questions, deficiency letters and registration-phase interactions.
- Provides expert medical evaluation of the clinical context of adverse event reports, relevant medical conditions and potential implications for Sandoz products in development. Contributes to medical and clinical documentation for registration dossiers for new submissions, including medical input to registration strategy, clinical overviews and responses to deficiency letters during the registration phase.
- Prepares Global Medical Development Product Packs for handover to Medical Affairs and supports preparation of medical launch materials, as applicable. Provides medical supervision of publication-related activities for study results, including medical journal publications, clinical study registries and regulatory assessment reports, where applicable. Identifies and engages contract research organizations or external service providers for selected medical activities and supports the Group Head, Global Medical Development, in contract-related, cost, quality and compliance activities as assigned.
Ideal Background
- Minimum 5 years of relevant experience in pharmaceutical product development, preferably including generics drug development and global or multi-country development activities.
- Background in medical development, clinical development, patient safety/pharmacovigilance and regulatory affairs, with understanding of drug development requirements, clinical study design and methodology, clinical data interpretation, benefit-risk principles and the regulatory environment for development and registration of pharmaceutical products.
- Experience contributing to regulatory interactions and Health Authority responses, including development- or registration-phase questions related to clinical, medical or safety topics.
- Ability to critically review scientific literature, treatment guidelines, clinical and nonclinical evidence, safety information and other relevant data sources, and to translate findings into clear medical insights for assigned products, development strategies and patient safety evaluation
Why Sandoz?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
#Sandoz
Skills Desired
Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Internal Medicine, Job Description, Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)
