Executive Director, Grs International Oncology Lead
vor 16 Stunden
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Executive Director, GRS International Oncology Lead
**Functional Area Description**
Responsible for providing International regulatory strategic support to global development programs and executing Health Authority negotiations in line with BMS strategy for assigned projects in the defined therapeutic area.
**Position Summary**
The GRS Int Oncology Lead is a member of the Global Regulatory Sciences (GRS) International Leadership Team, reporting to the VP of GRS International. This leader will collaborate with the GRS International LT and broader regional and global TA organization to enable and drive portfolio delivery for regions including EU and Intercon.
**Position Responsibilities**:
- Integrates the European and Intercon regulatory, legal, scientific/medical and business perspectives to achieve the optimal regulatory outcomes in accordance with company objectives.
- Translates strategy into operational goals and objectives, identifies resources and leads to organization to focus on objectives.
- Ensures that organization follows through to achieve high quality execution of plans.
- Contributes and adds value to the writing of scientific documents for regulatory purpose.
- Executes negotiations with EMA and ensure negotiations with HA in Intercon markets are in line with BMS strategy and provides strategic directions and supervises negotiations with other relevant regulatory agencies for assigned project.
- Provides direction for maximizing opportunities within projects (e.g. life-cycle) and across the geographical area to support the productivity priorities.
- Participates actively in and represents Global Regulatory Sciences for their project on various multifunctional committees or teams.
- Communicates actively and timely with Global Regulatory Sciences colleagues in European countries, and countries in the International region, including through direction of International Regulatory Teams.
- Active participation in regional organizational activities for the regulatory regional Lead function (across projects).
- Develops strong working relationships with key stakeholders both within and outside the company.
- Builds and maintains strong relationships with alliance partners when applicable.
- Watches, anticipates and acts on trends and changes in the European.
- Integrates cross-country regulatory issues/feedback, cross-asset regulatory issues/events to resolve issues.
- Closely monitors the evolving external environment for specific topics as assigned, liaises with appropriate internal stakeholders, raises awareness internally and participates in issue resolution
- Represents GRS International in internal and external regulatory strategy meetings and participates in issue resolution, as appropriate and as agreed.
**Core BMS Leadership Values**
**Integrity**
We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
**Innovation**
We pursue disruptive and bold solutions for patients
**Urgency**
We move together with speed and quality because patients are waiting
**Passion**
Our dedication to learning and excellence helps us to deliver exceptional results
**Accountability**
We all own BMS’ success and strive to be transparent and deliver on our commitments
**Inclusion**
We embrace diversity and foster an environment where we can all work together at our full potential.
**Degree Requirements**
Strong scientific/medical background/university scientific degree
**Experience Requirements**
Experience in Oncology is required
Minimum of 5 to 10+ years of global regulatory experience and drug development expertise
**Key Competency Requirements**
- Conducted prior negotiations with (a) regulatory authority(ies)
- Contributed to scientific documents developed for regulatory purposes, established credibility and respect during previous exposure with regulatory authorities and peers
- Demonstrated ability to react appropriately in difficult, possibly adverse, conditions and/or in crisis situations
- Demonstrated ability to integrate regulatory, scientific/medical and business perspectives and to translate this analysis into practical recommendations and operational goals
- Developed working relationships and/or built a team resulting in a performant network or organization
- Managerial experience (e.g. prior team leadership)
- Strong und
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