Associate Director, Global Regulatory Science, Precision Medicine and Digital Health
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.
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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us
· Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas
· Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
· Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers.
· Ensure consistent positions are presented in responses to global Health Authority (HA) queries.
· Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global Regulatory sub-team, develop global submission plans and HA interaction plans.
· Provide input into the development of protocol synopses and protocols.
· Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
· Contribute in the developing of target labeling.
Degree / Experience Requirements
· Bachelor’s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Regulatory Affairs experience
· Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance. Experience utilizing leadership techniques to drive a team through the stages of team development.
· Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
· Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience coordinating communications within teams and across functions.
· Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies.
· Ability to apply project management techniques within teams and effectively manage meetings.
· Demonstrated ability to breakdown complex, scientific content into logical components.
· Ability to coordinate global activities, facilitate issue resolution and conflict management.
· Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks.
· Demonstrated ability to negotiate with and influence others.
· Understanding of strategic and tactical role for the drug development process.
· Understanding of general global regulatory requirements for drugs in development.
· Understanding of R&D process and specific regulatory responsibilities/deliverables for the company decision points.
The starting compensation for this job is a range from $141,000-$200,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed. Final individual compensation will be decided based on demonstrated experience. For more on benefits, please visit our https://careers.bms.com/working-with-us. Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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