Hoffmann-La Roche - South San Francisco, CA
posted 30 days ago
About the position
Roche's Product Development (PD) organization is dedicated to delivering outstanding therapies to patients who need them. We conduct global clinical trials, analyze results, monitor safety, and work with regulatory authorities to provide truly differentiated medicines to patients. The Global Development Leader (GDL) plays an important role to achieve PD's vision. The GDL leads the cross-functional global development team (GDT) to deliver the molecule with maximum impact for patients. The responsibilities of the GDP include developing development strategies and ensuring effective and efficient execution for the assigned molecule(s) and indication(s). The GDL is a core member of the Asset Team and represents the Asset Team on its clinical development strategy and execution plans to internal stakeholders as well as health authorities, payors, patient associations and other key external stakeholders.
Responsibilities
- Lead and oversee the strategic, scientific, executional and registrational aspects of assigned development programs.
- Demonstrate strategic perspective by leading the team on designing asset strategy and target product profile aligned with business goals.
- Demonstrate late stage clinical development expertise, including in the transition from early to late stages of development.
- Align team efforts with strategic direction, developing a 'North Star' vision, purpose, and strategy for the GDT.
- Interpret and leverage financial data to inform decision-making, budget management, and resource allocation.
- Contribute to business forecasting as an equal partner in the Asset Team.
- Key contributor to the end to end asset strategy, ensuring a robust end-to-end Asset Strategy.
Requirements
- MD, MD/PhD, or PhD and disease area expertise in multiple sclerosis is preferred.
- 10 or more years pharma/biotech industry experience with at least 5 years in early/late stage development focusing on clinical trial design/execution.
- Extensive pharma/biotech industry experience with a proven record of leading strategic level teams.
- Proven track record in managing scientific and clinical teams in a matrixed organization.
- In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and relevant regulations.
- Experience submitting INDs/NDAs/BLAs to regulatory authorities.
- Strong understanding of principles of data analysis, interpretation and clinical relevance.
- Outstanding influencing and negotiation skills with an enterprise mindset.
- Ability to train, mentor and coach team members.
Benefits
- Flexible working options
- 18 weeks of maternity leave
- 10 weeks of gender independent partnership leave
- Child-care facilities
- Medical services
- Restaurants and cafeterias
- Various employee events
