Medical Evidence Generation (MEG) Lead
Cambridge, Massachusetts, Gentilly, France, Chilly-Mazarin, France, Amsterdam, Netherlands, Diegem, Belgium
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Medical Evidence Generation (MEG) Lead
About the Opportunity
Join Sanofi Genzyme as Medical Evidence Generation (MEG) Lead responsible for supporting the Global Medical Affairs Life cycle plan for caplacizumab and rilzabrutinib and the implementation of the evidence generation activities. This role includes leading or participating to several committees: SRC, CSS, LCM, GMT.
Possible locations for the role: Amsterdam (NL), Diegem (BE), Gentilly & Chilly Mazarin (FR), Cambridge (US).
About Sanofi Genzyme
Sanofi Genzyme, the specialty care business unit of Sanofi, focuses on rare diseases, multiple sclerosis, oncology, and immunology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat.
Our approach is shaped by our experience developing highly specialized treatments and forging close relationships with physician and patient communities. We are dedicated to discovering and advancing new therapies, and to providing hope to patients and their families around the world.
About growing with us
In this role you will…
- Provide leadership to phase IV programs to define life-cycle management strategy, identify needs for high value post-marketing clinical trials and registries, and oversee their management and execution. Ensure alignment across clinical trials, RWE studies and HEVA studies
- Provide input into novel life cycle management opportunities for caplacizumab and rilzabrutinib in phase IIIb to improve therapeutic and compliance benefits of the products. Define the strategies for ISS with other Team members, ensuring that they are aligned with strategic objectives for the products
- Lead the development of the LCM portion of the yearly Global Medical Affairs Plan, making sure that the Evidence Generation and LCM strategy is aligned with the identified strategic imperatives / critical success factors and data gaps. Develop medical strategies to obtain relevant data evidence from company and Investigator Sponsored Studies (ISS), including Real World Evidence, consistent with strategic objectives for each product
- Ensure and oversee the planning, execution and reporting of clinical studies as defined in the Global Medical Affairs plan and in accordance with established budgets and timelines. Monitor performance of phase IV activities (e.g. value creation) from conception through publication of clinical study results and take corrective actions or escalate issues as appropriate. Contribute to continuous improvement of phase IV study related processes and best practices
- Responsible for financial management and reporting requirements of LCM studies, ISSs, other Medical activities with accurate and timely data and assumptions to support budgeting, forecasting and long-range planning for the business unit
- Establish a strong network within the Medical Affairs organization (Global, Regional and local) and also with other stakeholders namely the R&D, the Clinical Sciences & Operations (CSO), RWE, HEVA and Pharmacovigilance teams. Partnering with and providing input to Product Lead(s) and Launch/Commercial Team(s) to define global product launch and life cycle management strategy
- Lead/co-chair DAC (Data Analytics Committee) responsible for peri-/post-approval data analyses (and evaluations to ensure appropriate prioritization of resources and effort towards generation of medical-scientific results. Represent Global Medical Affairs team at medical meetings, advisory boards, outreach meetings at key institutions and/or patient associations, and in interactions with KOLs related to LCM
Qualifications/ Education & work experience
- Biological Sciences degree combined with industry experience working in related areas (e.g. LCM, Clinical Development, Project Management, etc.), preferably related to Hematology
- 3+ years’ experience in managing clinical trials in a pharmaceutical or equivalent environment is strongly desired. Firm working knowledge of GCP, scientific and clinical methodology, protocol design, project management, regulatory requirements and compliance for conduct of clinical research essential
- Strong understanding of the pharmaceutical/biotech drug development and commercialization process
- Experience working within an international company with a matrix environment
- Ability to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena
- Leadership, communication, sense of urgency, team spirit, entrepreneurial skills
- Travel required up to 30%
- Oral and written fluency in English, another language is an asset
Inspire your Journey: what Sanofi can offer you:
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
- An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management)
- An individual and well-structured introduction and training when you onboard
- You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully
- As a globally successful and constantly growing company, Sanofi provides international career paths as well
This is our Sanofi. Discover yours.
If you feel you have the required experience please apply, alternatively contact firstname.lastname@example.org directly for more details.
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