Within Sanofi, we are committed to supporting medically and scientifically sound research aimed at the advancement of disease knowledge and potential treatments in therapeutic areas of interest to Sanofi with the goal of advancing patient care. Sanofi receives, reviews, and responds to unsolicited proposals from health care professionals (HCPs), scientists, and researchers or institutions (i.e. external sponsor) for research support, including Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC).
The ISS Operations Lead is accountable for the overall leadership of the ISS Operations function for Sanofi Genzyme. This team leader has a key organizational role in driving critical operational aspects and managing a best-in-class team to advance the oversight of ISS operations for Sanofi Genzyme Specialty Care worldwide.
This individual will lead a team of ISS program managers to ensure timely and compliant study start-up, execution, completion, and tracking of key research milestones as per research agreement for ISS approved by the SGZ Scientific Review Committee. This leader ensures organizational operation excellence by providing and advancing integrated operational support, continuous optimization of our processes and systems, transparent and up- to-date integrated communications platforms, consolidated management of systems utilized to manage these programs.
The role reports directly to the Sanofi Genzyme Head of Medical Operations
KEY RESPONSIBILITIES INCLUDE:
Establish and set direction of the evolution of ISS Operations function to lead best in class team focusing on development and delivery of optimal operational models for ISS program efficiency and continued full compliance of programs.
Evolve the operational focus of the team from a TA-centric allocation of associates to a model focusing across key areas of ISS operational excellence, including (but not limited to) ISS Performance, Supply Management, Contracting, Compliance and Transfer of Value, and overall ISS Program Systems Reporting.
Lead evolution of informatics/analyses to allow both retrospective and forecasting program management approaches to inform Medical Program Management decisions across Therapeutic Areas, ensuring full compliance management of ISS per Sanofi SOPS, policies & procedures.
Works cross-functionally to improve and simplify processes that can lead to measurable improvements in efficient and timely delivery of research agreements, product supply, study milestones, and other study deliverables.
Identifies metrics, develops KPIs and other business analytics to measure progress and inform investment decisions, ensuring updates are collected, documented, tracked, and communicated to stakeholders.
Collaborates with CMO function on reporting and cross-GBU initiatives related to ISS evolution.
Ensures PM team and relevant stakeholders are properly trained on ISS systems, tools and process, and provide mentoring, guidance and coaching to the PM team.
Accountable for the selection, onboarding, talent and career development of Program Management associates; accountable for ensuring adequate project allocation across areas of focus for ISS operations. QUALIFICATIONS
6+ years of relevant experience in Medical, regulated pharmaceutical environment, or other relevant experience
3+ years of prior direct management/leadership experience highly desired. Experience across several therapeutic areas/ functions preferred.
Bachelors education at minimum. Advanced education (e.g. PhD, PharmD) and/or Business qualifications (e.g. MBA, Project Management certification) preferred.
Substantial multi-disciplinary and/or cross-functional project leadership experience required.
Excellent knowledge of Medical Investigator Sponsored Studies program requirements and understanding of the external environment and regulations that impact the conduct of such programs, including GCP, ICH standards, OIG, PhRMA code, etc. highly preferred.
Proven leadership, capacity to coordinate several activities and stakeholders (including external partners) to ensure value added activities/prioritization/and strategic impact.
Strong leadership skills with a demonstrated ability to drive change in a matrix organization by fostering alignment and decision making
Strong quantitative, analytical (technical and business) and problem solving skills
Strong understanding of operating models of large organizations (Structure, processes, governance and systems) and strong vision on how to optimize efficiency with focus on performance management and excellence in execution
Proven self-starter with experience in building capabilities and driving efficiency in processes highly desirable. CORE COMPETENCIES
Act for Change - embrace change and innovation to initiate new and improved ways of working including evolution of reporting models and process simplification.
Cooperate Transversally - collaborate effectively with peers, stakeholders and partners across the organization, within and across GBUs, to positively impact ISS program efficiency and execution.
Strategic Thinking & Decision Making ability to think and plan broadly and long-term to inspire excellence in execution and timely decision making based on information available to adjust approaches that can positively impact evolution of the ISS Operations function.
Develop People - take responsibility for developing others and self in anticipation of future business needs.
Commit to Customers - Understand, meet and excel internal and external customer expectations to create positive impact through the evolution of the ISS Operations function.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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