Global Project Head, Solid Tumor Immuno-Oncology

Sanofi•Morristown, MA

3d•Onsite

About The Position

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.

Requirements

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 Haves

Experience leading pivotal trials to support submission for regulatory approval in solid tumor oncology.
Strong 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 strong networks internally and externally.
Experience in regional alliance partnerships or co-development
Strong 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.

Responsibilities

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.
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, and, if applicable, become responsible for the implementation of this Development strategy.