Global Project Head, Solid Tumor Antibody Drug Conjugates (ADCs)
Sanofi
18 days ago
Remote friendly (Cambridge, MA)
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 the optimal global compound development strategy in collaboration with the Global Brand Team (GBT).
- Own compound clinical development strategy and execution, including regulatory-focused studies and budget planning.
- Lead cross-functional GPT (translational, regulatory, drug manufacturing, safety, medical, and commercial compound leads) to ensure end-to-end compound strategy planning and implementation.
- Represent Clinical Development within the cross-functional GBT for commercial brand strategy.
- Partner with the Principal Clinical Lead (PCL) to 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 support implementation if applicable.
Requirements:
- MD or PhD.
- 7+ years of clinical development experience in Solid Tumor Oncology (biotech/pharma).
- Thorough understanding of global drug development and functional roles.
- Proven leadership of cross-functional clinical development teams.
- Experience with successful marketing authorization submissions.
- Excellent written and verbal communication skills.
- Ability to travel (20% domestic and international).
Preferred Qualifications:
- Experience leading pivotal trials for regulatory approval in solid tumor oncology.
- Experience preparing regulatory submissions and negotiating/discussing with health authorities.
- Experience collaborating with commercial/medical functions in launch and/or post-launch settings.
- Experience working in a matrix environment.
- Ability to adapt to evolving data/external landscape (CI, regulatory, etc.).
- Experience in regional alliances/co-development.
- 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 the optimal global compound development strategy in collaboration with the Global Brand Team (GBT).
- Own compound clinical development strategy and execution, including regulatory-focused studies and budget planning.
- Lead cross-functional GPT (translational, regulatory, drug manufacturing, safety, medical, and commercial compound leads) to ensure end-to-end compound strategy planning and implementation.
- Represent Clinical Development within the cross-functional GBT for commercial brand strategy.
- Partner with the Principal Clinical Lead (PCL) to 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 support implementation if applicable.
Requirements:
- MD or PhD.
- 7+ years of clinical development experience in Solid Tumor Oncology (biotech/pharma).
- Thorough understanding of global drug development and functional roles.
- Proven leadership of cross-functional clinical development teams.
- Experience with successful marketing authorization submissions.
- Excellent written and verbal communication skills.
- Ability to travel (20% domestic and international).
Preferred Qualifications:
- Experience leading pivotal trials for regulatory approval in solid tumor oncology.
- Experience preparing regulatory submissions and negotiating/discussing with health authorities.
- Experience collaborating with commercial/medical functions in launch and/or post-launch settings.
- Experience working in a matrix environment.
- Ability to adapt to evolving data/external landscape (CI, regulatory, etc.).
- Experience in regional alliances/co-development.