Sanofi
biopharma
GlobalProjectHead,SolidTumorImmuno-Oncology
Neural analysis suggests this role is
optimal for Senior candidates.
“Global Project Head, Solid Tumor Immuno-Oncology at Sanofi. Skills: clinical development, Solid Tumor Oncology, global drug development, cross-functional clinical development teams, marketing authorization submissions. Drives worldwide clinical development and life cycle management for a late-stage Sanofi immunotherapeutic compound within Solid Tumor Oncology.. Leads the GPT (global product team) to ensure optimal development of the global compound development strategy in collaboration with the ”
What You'll Achieve.
Ensure optimal development of the global compound development strategy.; Ensure correct planning and implementation of end-to-end compound strategy.; Successful submissions for marketing authorization.; Support submission for regulatory approval in solid tumor oncology.; Prepare regulatory submissions, and discussion / negotiation with health authorities.
Industry & Context.
Ability to integrate new information, adapt, and change direction in response evolving data and/or external landscape (CI, regulatory, etc).
20% travel domestic and international
What They're Looking For.
Must Have
MD or PhD, 7 or more years of experience in clinical development in Solid Tumor Oncology, in the biotech or pharmaceutical industry, Thorough understanding of global drug development and functional roles and responsibilities, Proven effective leadership of high-performing cross-functional clinical development teams, Experience in successful submissions for marketing authorization, Excellent written and verbal communication skills
Nice to Have
Experience leading pivotal trials to support submission for regulatory approval in solid tumor oncology., leadership and clinical expertise in the field, to enable effective international collaboration with external and internal stakeholders., Experience preparing regulatory submissions, and discussion / negotiation with health authorities., Experience collaborating with commercial and medical functions in launch and/or post-launch settings, Experience working in a matrix environment, Ability to integrate new information, adapt, and change direction in response evolving data and/or external landscape (CI, regulatory, etc)., Ability to develop networks internally and externally., Experience in regional alliance partnerships or co-development, interpersonal, cross-functional, and cross-cultural communication skills, Ability to define clear and challenging, but realistic, goals., Ability to assess the balance of investment and deliverables., Results and customer focused., Organizational awareness.
What You'll Do.
Drives worldwide clinical development and life cycle management for a late-stage Sanofi immunotherapeutic compound within Solid Tumor Oncology.
Leads the GPT (global product team) to ensure optimal development of the global compound development strategy in collaboration with the GBT (global brand team).
Accountable for the compound clinical development strategy and execution
with a focus on studies for regulatory purposes and including budget planning.
Collaborates with the Principal Clinical Lead (PCL) and Global Project Manager (GPM) to lead the cross-functional GPT (which includes translational
medical and commercial compound leads)
to ensure correct planning and implementation of end-to-end compound strategy.
Represents the Clinical Development function at the cross-functional GBT responsible for commercial brand strategy.
Partners with the PCL to present and discuss development strategy with key internal stakeholders
external investigators and advisory boards
and worldwide regulatory authorities.
Contributes to Sanofi Solid Tumor Oncology and cross-asset Disease Area strategies.
Responsible for the Clinical Development assessment of external business development opportunities in Hematopoietic Stem Cell Transplantation
become responsible for the implementation of this Development strategy.
How You'll Work.
Team & Collaboration
Leads the GPT (global product team) in collaboration with the GBT (global brand team).; Collaborates with the Principal Clinical Lead (PCL) and Global Project Manager (GPM) to lead the cross-functional GPT.; Represents the Clinical Development function at the cross-functional GBT.; Partners with the PCL to present and discuss development strategy with key internal stakeholders, external investigators and advisory boards, and worldwide regulatory authorities.; Effective leadership of high-performing cross-functional clinical development teams.; Experience working in a matrix environment.; interpersonal, cross-functional, and cross-cultural communication skills.
Communication Scope
Excellent written and verbal communication skills; interpersonal, cross-functional, and cross-cultural communication skills
Process & Methodology
global drug development, compound development strategy, budget planning, end-to-end compound strategy, planning and implementation
Full Job Description
**Job Title:** Global Project Head, Solid Tumor Immuno-Oncology **Location:** Cambridge, MA, or Morristown, NJ **About Job** Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. **** The Global Project Head (GPH) drives worldwide clinical development and life cycle management for a late-stage Sanofi immunotherapeutic compound within Solid Tumor Oncology. The GPH leads the GPT (global product team) to ensure optimal development of the global compound development strategy in collaboration with the GBT (global brand team). In this assignment the GPH will be accountable for the compound clinical development strategy and execution, with a focus on studies for regulatory purposes and including budget planning. The GPH will collaborate with the Principal Clinical Lead (PCL) and Global Project Manager (GPM) to lead the cross-functional GPT (which includes translational, regulatory, drug manufacturing, safety, medical and commercial compound leads), to ensure correct planning and implementation of end-to-end compound strategy. The GPH will represent the Clinical Development function at the cross-functional GBT responsible for commercial brand strategy. The GPH will partner with the PCL to present and discuss development strategy with key internal stakeholders, external investigators and advisory boards, and worldwide regulatory authorities. **** The Global Project Head is also an essential contributor to Sanofi Solid Tumor Oncology and cross-asset Disease Area strategies. The GPH will be responsible for the Clinical Development assessment of external business development opportunities in Hematopoietic Stem Cell Transplantation, and, if applicable, become responsible for the implementation of this Development strategy. **** **About Sanofi** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering
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