Associate Director Mature and Established Brands
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
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. 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.
The Mature and Established brand Associate director is responsible for the medical affairs related activities for brands in late LCM Medical Leadership.
Lead medical insight at cross-functional teams for assigned products.
Propose labeling recommendations based on proactive signal detection activities.
Provide Medical Assessments of Risk/Benefit of assigned products regarding new
indications, safety or stability issues, medical necessity/sensitivity assessments or other
actions that require reappraisal of the product Risk/Benefit.
Provide medical input for regulatory requirements including: Response to Health Authorities queries, support for registration renewals and label periodic reviews. Provide medical support to the CCDS content review and development.
Provide medical evaluation and appropriate communications to additional documents and
activities such as: Dear Health Care Professional letters, Clinical Overview for Type II
variation and coordinate expert reports.
Compliance Support delivery of medical affairs
compliance needs for the assign portfolio as appropriate. Demonstrate ability to apply BMS
operating philosophy and operate within company policies and procedures and appropriate
Collaboration: Partner with local market organizations as appropriate regarding medical deliverables and portfolio functions.
Collaborate to key cross-functional partners, GRS MP, Global Labeling,
Knowledgeable and skilled in medicine and pharmaceutical product
preferably related to both clinical trial and post-marketing safety.
Ability to provide input in cross disciplinary matrix teams, promote collegiality and teamwork among team members.
Ability to think clearly and decisively and present independent, reasoned solutions to
identified safety issues.
Demonstrated creative problem solving skills that enact change and drive continuous
Familiarity with regulatory guidelines. Seek to develop self and others. Aligns objectives with organizational goal. Excellent oral and written communication, interpersonal and time management skills. Demonstrate flexibility, open mindedness and adaptability in a rapidly changing environment.
MD or Equivalent.
Board certification and medical specialty preferred.
2-4+ years in clinical practice
1-2+ years of pharmaceutical industry experience preferred
1-2+ years of clinical safety experience preferred
Candidate should be qualified with Physician (Required).
Considerable experience in Matrix Management Experience would be an advantage.
Considerable experience in Multi-Brand Experience would be an advantage.