Global Project Head, Solid Tumor Immuno-Oncology

About the role

Join the engine of Sanofis mission where deep immuno-science meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Responsibilities

• Drive worldwide clinical development and life cycle management for a late-stage Sanofi immunotherapeutic compound within Solid Tumor Oncology.
• Lead 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.
• 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.
• Represent the Clinical Development function at the cross-functional GBT responsible for commercial brand strategy.
• Partner with the PCL to present and discuss development strategy with key internal stakeholders, external investigators and advisory boards, and worldwide regulatory authorities.
• Essential contributor 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.

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
• 20% travel domestic and international

Qualifications

• Basic Qualifications:
• 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
• 20% travel domestic and international
• Preferred Qualifications:
• 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 to 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

Benefits

• Comprehensive health and wellness benefits including high-quality healthcare, prevention, and wellness programs
• At least 14 weeks gender-neutral parental leave
• Additional benefits information can be found here

Pay

Compensation will be determined commensurate with demonstrated experience.

Schedule

Full time