Director, Global Regulatory Sciences, Precision Medicine and Digital Health
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
· 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 7 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.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and 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.
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