Vice President, Therapeutic Area Head - Oncology, Global Regulatory Sciences > Boudry > Joboolo CH :
Company : Bristol Myers Squibb Location : Boudry Neuchâtel From : Neuvoo CH
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VicePresident,TherapeuticAreaHead – Oncology,GlobalRegulatorySciences The Head of GRS Oncology is a senior executive level role considered critical to the sustainability and success of the BMS R&D pipeline.
This role reports to the Head of GlobalRegulatorySciences and is a key member of the GRS Leadership Team.
Position Responsibilities:
Providing strategic and operational leadership to all of the GRS Oncology TherapeuticArea.Leading a highly strategic team of regulatory professionals that contribute significantly to BMS’ competitive position in Oncology.
Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential.Providing overall leadership and regulatory guidance across the portfolio that shapes the direction of BMS teams (e.G., Regulatory Team, Multi-functional Development team, and Oncology Development team) based on a solid understanding of the disease, science, competition and regulations.Ensuring successful negotiation strategies and execution of interactions with US and EU regulatory agencies.
Provides global guidance to the regional strategists and collaborates in strategic meetings with health authorities outside US/EU, especially Japan and China.Representing the Company in key interactions with health authorities by overseeing and leading the preparation of effective, persuasive presentations to regulatory authorities and creates clear and concise documents regarding regulatory strategy for senior management.Providing strategic direction regarding dossier content to ensure that knowledge of the drug, disease, and specific regulatory requirements of regulatory authorities are incorporated.Building and developing the GRS global strategy organization with the overall aim to reduce development and review times and optimize labels based on in-depth understanding of the globalregulatory landscape.
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 processServing as an influential leader across R&D, and developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.Ensuring GRS representation as needed in governance or strategic teams or committees (preparatory materials, direct participation, or representative of the TA by delegation).
Reviews and endorses key development documents (target labelling, pivotal protocols/study design, analytical plans, Risk Management Plans, Pediatric Plans, and Comparability Plans as appropriate).Proposing or endorsing Regulatory consultancies/advisory boards based on clear objectives; supports the conduct ofsuch processes (preparatory material, list of questions, and communication of outcomes).Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.Fostering an open and transparent environment that encourages innovation and passion for career development and growth.
Degree Requirements:
MD or PhD preferred Experience Requirements:
Significant globalregulatory expertise and a successful track record of leading through influence and working across complex, global organizational matrices.
MD or PhD preferred, with 10+ years of relevant industry experience, as well as experience working with senior R&D and commercial leadership teams.Advanced scientific and clinical knowledge related to multiple therapeuticareas with specific expertise in Oncology, as well as a strong understanding of the drug development process.Demonstrated understanding of the science underlying relevant diseases and its impact on the regulatory process.In-depth experience in pharmaceutical product development and significant direct experience in Liaison activities.Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (CMC, preclinical, clinical, statistics, market access specialists, Legal, etc.).Broad intelligence of the regulatory environment across key regions, and anticipation of future trends and impact.Strong influential leadership and communication capabilities.
?Key Competency Requirements:
15+ years of relevant Industry experience Travel Required:
Yes If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway.
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