Global Project Head, Solid Tumor Immuno-Oncology
Sanofi
19 days ago
Remote friendly (Morristown, NJ)
United States
$232,500 - $335,833.33 USD yearly
Clinical Research and Development
Role Responsibilities:
- Drive worldwide clinical development and life cycle management for a late-stage solid tumor oncology immunotherapeutic 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, 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.
- Assess external business development opportunities in Hematopoietic Stem Cell Transplantation for Clinical Development; support implementation as applicable.
Qualifications:
- MD or PhD.
- 7+ years of clinical development experience in Solid Tumor Oncology (biotech or pharmaceutical).
- 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 and negotiating with health authorities.
- Experience working in matrix environments and collaborating with commercial/medical functions in launch/post-launch settings.
- Ability to adapt to evolving data/regulatory/CI landscape.
Benefits:
- Health and wellbeing benefits including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Drive worldwide clinical development and life cycle management for a late-stage solid tumor oncology immunotherapeutic 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, 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.
- Assess external business development opportunities in Hematopoietic Stem Cell Transplantation for Clinical Development; support implementation as applicable.
Qualifications:
- MD or PhD.
- 7+ years of clinical development experience in Solid Tumor Oncology (biotech or pharmaceutical).
- 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 and negotiating with health authorities.
- Experience working in matrix environments and collaborating with commercial/medical functions in launch/post-launch settings.
- Ability to adapt to evolving data/regulatory/CI landscape.
Benefits:
- Health and wellbeing benefits including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.