ISS Operations Lead
Posted on: October 13, 2019
POSITION DESCRIPTION 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 OperationsKEY
- 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 KPI?s and other business analytics
to measure progress and inform investment decisions, ensuring
updates are collected, documented, tracked, and communicated to
- 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
- 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. ?
- Bachelor?s 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
- 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
- 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
- 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
- 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.#GD-SG#LI-GZAt 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.
Keywords: SANOFI, Boston , ISS Operations Lead, Other , Cambridge, Massachusetts
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