Job Description

Position Overview:

Sanofi Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees.  With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve.  Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.

The Director, Lifecycle Management and Engagement Strategy (LCMES), Global Medical Affairs role is a high visibility, strategic and operational position reporting to Head MS, Neurology and Immunology Global Medical Affairs.  This is an exciting opportunity to work in a patient-centric, multi-national culture.

The Director, LCMES will be a member of the MSNI Global Medical Affairs team, providing input into life cycle management and engagement opportunities for products in the commercialized portfolio, and Sanofi’s expanding neurology development pipeline. The Director of LCMES has a crucial role in the development of annual Global Medical Plans, Integrated Evidence Generation Plans, and Scientific Communication and Engagement strategies. He/she will work in a matrix participating as a member of various Medical Affairs, Clinical Sciences & Operations (CSO), and cross-functional teams and committees to further strengthen evidence and insight generation for the MS and neurology franchise. 

The Director of LCMES will partner with Clinical Sciences & Operations (CSO) and Medical Project Management teams to oversee execution of our ongoing Phase IV and Investigator Sponsored Studies (ISS) and with the MSNI Scientific Communication team to coordinate related publication generation and review, as appropriate. He/she will support the integrated evidence generation and dissemination for Genzyme’s neurology pipeline assets through innovative approaches to assessing data and publication gaps, unmet medical needs, and competitor analyses. Further, the Director of LCMES will play a pivotal role in the department’s scientific engagement by developing and executing our Global advisory board strategy, and contributing to our scientific congress strategy.

Key Responsibilities:

Provide oversight, management, and cross-functional coordination of our ongoing Phase IV and ISS program.

Direct and execute innovative strategies to assess critical data gaps, publication gaps, unmet medical needs for Sanofi’s neurology assets, and perform analyses of relevant competitors.

Develop and execute strategies to obtain relevant data evidence from company, collaborative, and Investigator Sponsored Studies (ISS), including Real World Evidence, consistent with strategic objectives for each product. Ensure that appropriate processes are in place for review, approval, management and support of studies while maintaining investigator independence where appropriate.

Apply innovative data and publication needs assessments to the annual Global Medical and Scientific Communication and Engagement Plans.

Communicate product life-cycle management strategy to regional/local Medical Affairs experts and product managers.  Ensure that studies planned by regional and local affiliates fit into the global product strategy.

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 from conception through publication of clinical study results and take corrective actions or escalate issues as appropriate. 

Ensure financial management and reporting requirements of LCM studies and ISSs with accurate and timely data and assumptions to support budgeting, forecasting and long range planning for the business unit.

Plan, lead, and execute Global Medical and Scientific Communication advisory boards, round tables and ensure actionable insights are communicated to key Sanofi stakeholders, and are incorporated into relevant strategic plans.

Plan and execute thought leader engagements at major scientific congresses or other academic meetings to further strengthen Sanofi’s partnership with the external scientific community.

Basic Qualifications:

Advanced scientific degree (e.g. PharmD, PhD or M.D.) combined with industry experience and management skills working in related areas (e.g. LCM, Clinical Development, Project Management, etc.), preferably related to MS and neurology.

Experience in developing and/or 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.

Experience in scientific publications, medical communications, scientific engagement, and applicable guidelines that dictate these types of activities.

Basic experience in financial planning and budget management

Preferred Qualifications:

Demonstrated ability to work effectively in a matrix environment.

While this integral role would ideally be located at the Sanofi US Headquarters in Cambridge MA, the ideal candidate would have extensive experience in international markets, with diverse cultures, and fluency in multiple languages would be a plus.

Excellent skills working cross functionally, specifically partnering with all the internal and external stakeholders.

High energy, a great attitude, and an absolute commitment to a culture that operates with high ethical standards and strives to exceed all goals and objectives.

Comfort operating in a consensus building role but also able to make critical decisions and drive these decisions through the organization.