Director/Group Director Strategist Oncology-USL
- Employer
- Bristol Myers Squibb Company
- Location
- Princeton, NJ, US
- Start date
- Dec 13, 2018
View more
- Discipline
- Science/R&D, Oncology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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.
Responsibilities
- Develop US regulatory strategy for Oncology products in development and through life cycle management taking into account all relevant guidance, commercial needs and company objectives.
- Develop strategic direction and provide leadership for all regulatory interactions with FDA
- Anticipate and interpret key trends and changes in the U.S. regulatory environment and provide strategic guidance regarding development plans as a result.
- Foster positive relationships with FDA.
- Build and maintain a strong, collaborative relationship with all key stakeholders including U.S. Commercial, U.S. Medical Affairs, U.S. Promotion & Compliance, Global Development and other functions key to the success of product development.
- Interact routinely and will develop a strong team environment with colleagues throughout GRS, including GRT leaders and other key functions within GRS.
Qualifications
- Ph.D., M.D., PharmD. , MS or commensurate experience with significant experience in Us regulatory affairs (e.g. > 7 years)
- Expert understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval.
- Expert understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology.
- Direct experience in developing strategy and leading teams through interactions with FDA.
- Extensive experience in initiating and conducting successful interactions within FDA.
- Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals
Company
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.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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