Global Project Head, Solid Tumor Antibody Drug Conjugates (ADCs)
Sanofi · Cambridge, MA · 2 wk ago
On-siteManagementFull-time
About the role
The Global Project Head (GPH) drives worldwide clinical development and life cycle management for a late-stage Sanofi Antibody Drug Conjugate (ADC) 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).
Key Responsibilities
- Drive the compound clinical development strategy and execution, focusing 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), ensuring 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.
- Contribute to Sanofi Solid Tumor Oncology and cross-asset Disease Area strategies, assessing external business development opportunities in Hematopoietic Stem Cell Transplantation, and implementing these strategies if applicable.
About You
- 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
Why Choose Us
- Bring the miracles of science to life alongside a supportive, future-focused team
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave