Director of Global Regulatory Strategy
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
- Global Regulatory Strategy Lead (GRTL) Oncology will have leadership responsibility for global regulatory strategy on the oncology and immuno-oncology early development teams (EDTs).
- Provide leadership to the global regulatory team (GRT) (e.g., communicate issues, execute against action items) and establish one regulatory voice. Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies. Create an asset specific global health authority (HA) interaction strategy, integrating regional/local objectives and strategies.
- Propose innovative approaches to resolve complex regulatory issues and increase speed to patients
- Support the preparation of, and participate in (as appropriate), key HA interactions. Assure consistent positions on common issues are presented to global HA. Drive the development and on time completion of HA background documents and responses to queries from HAs.
- Provide strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs.
- Experience in successfully leading teams and the ability to broadly represent the GRS functions on project teams.
- Demonstrated matrix leadership skills and the ability to work effectively across multiple disciplines internal and external to the organization.
- Understanding of science in oncology and impact on the regulatory process
- Strong understanding of the drug development process and global regulatory requirements for drugs in development
- Advanced technical degree, e.g., PhD, MD, PharmD, M.S. is preferred. Specific regulatory experience within Oncology is preferred.