Head of Clinical Development
The Head of Clinical Development is an experienced clinical development executive who will be the key BridgeBio Oncology representative internally and externally on medical and scientific information and issues related to BridgeBio Oncology products. S/he is responsible for planning, implementing, directing, and managing the clinical and regulatory development/strategy of BridgeBio Oncology products. This individual will direct all clinical activities, provide medical and operational leadership for the company’s clinical programs, and will be instrumental in bringing the company’s first therapeutic from preclinical to clinical stage development.
Essential Skills & Functions:
The Head of Clinical Development will be responsible for building and leading BridgeBio Oncology clinical development operations organization. Specific responsibilities include:
- Lead, build and manage a top level clinical development team, establishing a high-achieving and collaborative culture.
- Design clinical and regulatory strategies in the context of the corporate strategy. Collaborate with management on portfolio selection.
- Develop and execute the clinical development strategy for new therapeutic candidates from preclinical through to Phase 2 studies, taking into account the constraints of a small and creative biotechnology company.
- Lead and inspire BridgeBio Oncology research groups; manage deliverables, timelines, and budget.
- Cultivate strong and transparent relationships with internal leadership, the Board of Directors, and the Scientific Advisory Board, ensuring open communication.
- Collaborate with the company’s founders and SAB; communicate advances and share scientific discussions relevant to the company’s progress to ensure success.
- Manage the global clinical safety according to all local and international requirements, ensuring GCP compliance of all clinical trials.
- Oversee resource allocation and decision-making across the portfolio of research initiatives.
Preferred Education and Experience:
- 10 years pharmaceutical/biotechnology clinical development experience
– Senior, seasoned pharmaceutical/biotechnology executive with clinical development experience at strategic and operational levels. Ideally has experience in a start-up environment.
- 7 years pharmaceutical/biotechnology operational leadership of clinical development
– Demonstrated proficiency in the implementation, monitoring, and management of clinical trials, timelines, and budgets. Expertise in clinical program administration.
- Team building and leadership experience
– Demonstrated success in hiring and building world class teams. Directly supervised and managed clinical staff.
- Experience in translational medicine in oncology, with success advancing products through the regulatory approval process
– Understanding of preclinical data and requirements to move a product into first in man studies. Track record of moving quality drug candidates into the clinic, from filing IND applications to designing and operationalizing clinical trial programs, ideally beyond IND to Phase 2 trials.
– Medical Doctor degree is required.