Global Project Head, Solid Tumor Antibody Drug Conjugates (ADCs)
Sanofi
14 hours ago
Remote friendly (Morristown, NJ)
United States
$232,500 - $335,833.33 USD yearly
Clinical Research and Development
Key Responsibilities:
- Drive worldwide clinical development and life cycle management for a late-stage Solid Tumor Oncology antibody drug conjugate (ADC) compound.
- Lead the Global Product Team (GPT) to ensure optimal global compound development strategy in collaboration with the Global Brand Team (GBT).
- Own compound clinical development strategy and execution, including studies for regulatory purposes and budget planning.
- Lead cross-functional GPT planning and implementation of end-to-end compound strategy (translational, regulatory, drug manufacturing, safety, medical, and commercial compound leads).
- Represent Clinical Development within the cross-functional GBT for commercial brand strategy.
- Present and discuss development strategy with internal stakeholders, external investigators, advisory boards, and worldwide regulatory authorities.
- Contribute to Solid Tumor Oncology and cross-asset Disease Area strategies; assess external business development opportunities in Hematopoietic Stem Cell Transplantation and, if applicable, lead implementation.
Requirements:
- MD or PhD.
- 7+ years of experience in clinical development in Solid Tumor Oncology (biotech or pharmaceutical industry).
- Thorough understanding of global drug development and functional roles/responsibilities.
- Proven leadership of high-performing cross-functional clinical development teams.
- Experience with successful marketing authorization submissions.
- Excellent written and verbal communication skills.
- 20% domestic and international travel.
Preferred Qualifications:
- Experience leading pivotal trials for regulatory approval in solid tumor oncology.
- Experience preparing regulatory submissions; discussion/negotiation with health authorities.
- Experience collaborating with commercial and medical functions in launch and/or post-launch.
- Experience working in a matrix environment and in regional alliance partnerships/co-development.
- Ability to integrate new information, adapt to evolving data/external landscape, and build internal/external networks.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
Application instructions:
- Not provided.
- Drive worldwide clinical development and life cycle management for a late-stage Solid Tumor Oncology antibody drug conjugate (ADC) compound.
- Lead the Global Product Team (GPT) to ensure optimal global compound development strategy in collaboration with the Global Brand Team (GBT).
- Own compound clinical development strategy and execution, including studies for regulatory purposes and budget planning.
- Lead cross-functional GPT planning and implementation of end-to-end compound strategy (translational, regulatory, drug manufacturing, safety, medical, and commercial compound leads).
- Represent Clinical Development within the cross-functional GBT for commercial brand strategy.
- Present and discuss development strategy with internal stakeholders, external investigators, advisory boards, and worldwide regulatory authorities.
- Contribute to Solid Tumor Oncology and cross-asset Disease Area strategies; assess external business development opportunities in Hematopoietic Stem Cell Transplantation and, if applicable, lead implementation.
Requirements:
- MD or PhD.
- 7+ years of experience in clinical development in Solid Tumor Oncology (biotech or pharmaceutical industry).
- Thorough understanding of global drug development and functional roles/responsibilities.
- Proven leadership of high-performing cross-functional clinical development teams.
- Experience with successful marketing authorization submissions.
- Excellent written and verbal communication skills.
- 20% domestic and international travel.
Preferred Qualifications:
- Experience leading pivotal trials for regulatory approval in solid tumor oncology.
- Experience preparing regulatory submissions; discussion/negotiation with health authorities.
- Experience collaborating with commercial and medical functions in launch and/or post-launch.
- Experience working in a matrix environment and in regional alliance partnerships/co-development.
- Ability to integrate new information, adapt to evolving data/external landscape, and build internal/external networks.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
Application instructions:
- Not provided.