Responsibilities:
- Drive worldwide clinical development and life cycle management for a late-stage solid tumor immuno-oncology compound.
- Lead the Global Product Team (GPT) to optimize the 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.
- Partner with the Principal Clinical Lead (PCL) and Global Project Manager (GPM) to ensure end-to-end strategy planning and implementation across translational, regulatory, drug manufacturing, safety, medical, and commercial leads.
- Represent Clinical Development within the cross-functional GBT responsible for commercial brand strategy.
- Present and discuss development strategy with internal stakeholders, external investigators/advisory boards, and worldwide regulatory authorities.
- Contribute to disease area strategy; assess external BD opportunities in hematopoietic stem cell transplantation and, if applicable, implement the resulting development strategy.
Qualifications:
- MD or PhD.
- 7+ years of clinical development experience in Solid Tumor Oncology (biotech or pharma).
- 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:
- Experience leading pivotal trials for solid tumor regulatory approval.
- Experience preparing regulatory submissions and negotiating with health authorities.
- Experience collaborating with commercial/medical functions in launch or post-launch.
- Experience in a matrix environment; ability to adapt to evolving data/regulatory landscape; strong internal/external networks.
- Experience with regional alliances/co-development.
Benefits:
- At least 14 weeksβ gender-neutral parental leave; high-quality healthcare and prevention/wellbeing programs.
Application instructions:
- Not provided in the text.