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Global Regulatory Team Leader, Oncology, Global Regulatory &

Company: Adecco Group
Location: Princeton
Posted on: February 25, 2021

Job Description:

Global Regulatory Team Leader, Oncology, Global Regulatory & Safety Sciences (D9 Senior Director-Team Leader)

  • Medical and Regulatory Affairs
  • R1533252
  • Full Time
  • 2020-12-14T00:00:00+0000 mail_outlineGet future jobs matching this search or Job Description 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. Global Regulatory Team Leader, Oncology, Global Regulatory & Safety Sciences Division R & D / GRSS / Global Regulatory Strategy and Policy (GRSP), Oncology Functional Area Description Position Summary / Objective
    Team Leadership responsibility for global regulatory strategy across multiple development teams (DTs). Position Responsibilities 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. Degree Requirements Solid scientific background, Ph.D., M.D., PharmD, MS, or BS Experience Requirements Significant experience in regulatory affairs (e.g. > 8-10 years) Key Competency Requirements
    Required: --- 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 (outlicensing, 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 Travel Required Yes 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.

Keywords: Adecco Group, Trenton , Global Regulatory Team Leader, Oncology, Global Regulatory &, Hospitality & Tourism , Princeton, New Jersey

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