Responsibilities:
- Drive worldwide clinical development and life cycle management for a late-stage immunotherapeutic compound in Solid Tumor Oncology.
- 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 regulatory-focused studies and budget planning.
- Lead cross-functional GPT planning and end-to-end execution (translational, regulatory, drug manufacturing, safety, medical, and commercial leads).
- Represent Clinical Development within the cross-functional GBT for commercial brand strategy.
- Partner with the Principal Clinical Lead to present development strategy to internal/external stakeholders, investigators, advisory boards, and worldwide regulatory authorities.
- Contribute to Solid Tumor Oncology and cross-asset Disease Area strategies; assess external BD opportunities in Hematopoietic Stem Cell Transplantation and implement development strategy if applicable.
Qualifications:
- 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.
- 20% domestic/international travel.
Preferred:
- Experience leading pivotal trials for regulatory approval in solid tumor oncology.
- Regulatory submission preparation; discussion/negotiation with health authorities.
- Launch/post-launch collaboration; matrix experience; ability to adapt to evolving data/external landscape.
- Experience with regional alliances/co-development; strong cross-cultural communication.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention/wellness programs, and at least 14 weeksβ gender-neutral parental leave.