Global Regulatory Team Leader Oncology Global Regulatory Safety amp Biometrics

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

Team Leadership responsibility for global regulatory strategy across multiple development teams (DTs).

Leadership responsibility for global regulatory strategy across multiple DTs, including the Early and/or Full Development Teams across indications. This requires coaching and mentoring of Global Regulatory Leads (GRL) responsible for the leadership of their respective DTs and US lead (USL) responsible for their assigned US submissions.

Provides guidance to the regional strategists and collaborates in strategic meetings with health authorities.

Represents BMS in key interactions with Health Authorities.

Provides ongoing feedback, coaching, and career development support to staff in order to maximize their potential.

Remains on the forefront of the relevant science and competitive landscape including detailed competitive intelligence and is viewed as an expert in its application to the regulatory process.

Provides guidance on planning, writing, review of key dossier documents for submission globally; signs off on integrated summary documents

Ensure Global Regulatory Sciences representation as needed in governance or strategic teams or committees.

Solid scientific background, Ph.D., M.D., PharmD, MS, or BS

Significant experience in regulatory affairs (e.g. > 8-10 years)

Requirements

Understanding of scientific content and complexities and good knowledge of Oncology drug development is desired.

Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.

Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval.

Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.

Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks.

Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.

Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.

Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.

Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.

Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.

Experience as a member of GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions).

Experience utilizing leadership techniques to drive a team through the stages of team development.

Proven ability to coach and mentor other leaders as a coach, while being an individual contributor to projects.

Successful track record of leading through influence and working across complex, global organizational matrices.

Experience working with senior R&D and commercial leadership teams

Other Qualifications

Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals.

Communicates opinions, facts and thoughts with clarity, transparency and honesty

Sets clear and high expectations and holds self and others accountable for decisions and results achieved.

Seeks multiple perspectives and listens openly to others’ points of views.

Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.

Demonstrates ownership of results within (and beyond) area of responsibility.

Sets clear and high expectations and holds self and others accountable for decisions and results achieved.

Looks for opportunities for continuous improvement.

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com