Global Medical Development Manager
Location
Hyderabad | India
Job description
About the role
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!
Position Purpose:
The Global Medical Development Manager (GMDM) provides medical development expertise and medical supervision to the development of products. This includes responsibility for the medical aspects of setting up / executing the development strategy (e.g. medical impact of technical as-pects), medical assessments of new opportunities to be pursued by Global Portfolio Management (Global PfM) and Business Development and Licensing (BD&L) groups, medical contribution to the overall clinical strategy and individual clinical studies in close collaboration with the clinical development team. The GMDM provides knowledge on disease state, patients’ needs, compre-hensive understanding of the medical development relevant scientific literature and treatment and development guidelines. They serve as a medical / scientific knowledge reservoir with re-spect to Sandoz products in development / life cycle management development activities. The GMDM works with a high ethical standard in compliance with GCP and all relevant internal and external guidance documents.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
• Identifies the medical development implications of pre-clinical findings, drug formulation information, regulations and any other relevant medical information. Engages in product or indication specific analysis of existing data sources (both internal and external) – where necessary / where appropriate - to develop medical insights in optimization of the formulation, medical device and medical therapy, improved clinical outcomes, enhanced value proposition, and new insights into disease pathophysiology with the aim to increase the probability of success of the product development. Includes the regular update of pharmaceutical and medical assessments (e.g. regarding efficacy and safety of medicinal products, treatment guidelines, standard of care) to support product development optimization, and to use in discussions with regulatory authorities as necessary (e.g. Scientific Advice, briefing book, PIP, including waivers and deferrals).
• Provide medical expert assessment to support selection of new product opportunities pursued by Global and Business Development and Licensing (BD&L). Provides medical input to product development teams and patent department during product development phase according to milestone guidance. Provides training of other functions in development with regard to pharmaceutical and medical issues (indications, posology, pharmacokinetics, pharmacodynamics, efficacy and safety). Active collaboration with cross-functional partners, including, but not restricted to: other functions within Product Development; Global QA (e.g. medical risk assessments for escalations) and Pharmacovigilance (e.g. RMP/pregnancy prevention program/plan, DHPC); Technical Operations (e.g. definition of MDD); Portfolio Stewardship. Collaborates with external experts as indicated by project/product requirements (e.g. KEE, etc.), other functions within Product Development (i.e. Global Portfolio Management; Regulatory Affairs); BD&L, Global Portfolio Management, Commercial Operations (i.e. Global Commercial Strategy).
• Provides input to clinical study design (including study population) and owns the preparation of scientific documents (e.g. Investigator’s Brochure and patient consent form for non-standard generics clinical development [e.g. clinical endpoint studies or BE studies in patients]), contributes to annual safety reports, Risk Management Plans. Participates in the Sandoz Study Board for applicable projects. Aligns with Clinical Development for reporting of clinical data in Clinical Overview. Represents the function Global Medical Development as subject matter expert in cross-functional initiatives or Center(s) of Excellence (e.g. Medical Devices) and development platforms across sites, and to external partners.
• Performs Medical Monitoring for clinical studies in patients according to applicable requirements. Medical interpretation of study results for clinical endpoint or safety studies. When development issues arise which could have an impact on subject / patient safety, gathers relevant information to either resolve issues and/or recommend decisions to amend / terminate the study or the development project (if applicable) in collaboration with appropriate functions e.g. patient safety.
• Identifies and engages with contract research organizations for selected GMD activities; supports Head Global Medical Development in the responsibility for drafting of contracts, cost optimization and management, professional and regulatory compliance.
• Medical writing for registration purpose: Medical and clinical documentation (including alignment with Clinical Development for reporting of clinical data in Clinical Overview) for registration dossiers for new submissions, including medical input to Registration Strategy (e.g. application type, data protection period) and responses to deficiency letters during registration phase. Medical and clinical documentation during maintenance phase (e.g. Renewals, Variations, deficiency letters), including product Life Cycle Management activities.
• Prepares Global Medical Development Product Pack for handover to Medical Affairs for preparation of medical launch material. Medical supervision of publication of study results (e.g. medical journals, clinical study registries, regulatory assessment reports). Participates in the review of submitted IIT or country level post marketing studies (e.g. post marketing clinical activities such as registry / database projects, epidemiological surveys, and post-authorization studies – including referral studies) under the guidance of the Head Post Marketing Studies. Participates in the Sandoz Study Board as necessary.
• Ability to cover several Therapeutic Areas. Contributes to continuous improvement initiatives, process optimization, development of relevant templates and processes, up-to-date with industry and health authority trends, gathering external/internal knowledge in relevant fields and bring it back to the broader organization. Other tasks, as directed by the supervisor, or based on specific appointment, or determined during the annual objectives setting process, or by relevant key performance indicators.
Role Requirements
What you’ll bring to the role:
Essential Requirements:
• Academic degree in medicine, pharmacy or life-science is required to ensure the incumbent has the necessary theoretical and practical knowledge to lead the science.
• Min 5+ years’ Product Development experience in the pharmaceutical industry in local or global roles, Background in medical development, clinical development and regulatory affairs. Understanding of drug development; knowledge of the regulatory environment; experience in overseeing or conducting clinical trials; understanding of trial design and methodology and have an advanced scientific understanding and medical knowledge.
• Experience in interacting with regulatory authorities, ability to critically review current literature, providing relevance to our products and markets. Collaborative, team-oriented approach. Being an adept at developing and supporting relationships across an organization as well as with key external stakeholders and the healthcare community at large. Experience being an active contributor to cross-functional teams and/or working in matrix organizations will be essential. Drive joint value generation (pro-actively taking ownership). Strong communication and presentation skills; experience operating in international medical environments.
• Has strategic mind-set, able to handle complexity. Agility to work on different TA areas, with ability to anticipate and plan for the future and to see a broader picture; high quality, critical thinking, process and performance orientated; anticipates issues and implements contingency plans to avoid missed deliverables / expectations; ability for continuous learning and able to apply knowledge, expertise, gained insights to business requirements. Planning and organizational ability; budget management.
• Exercises good judgment on regulatory, legal, quality and technical related compliance issues; ensures compliance obligations are met across all areas of responsibility.
• Positive and ‘can-do’ approach; biased towards finding solutions and win/wins; responsiveness and flexibility. High Integrity; trustworthy; strong compliance and quality mind-set. Excellent team playing and communication skills; strong sense of ownership and accountability.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
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.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)
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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.
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