Senior Director Team Leader Regulatory Strategy Oncology

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.

Job Description

Team Leadership responsibility for global regulatory strategy across multiple development teams (DTs). Develop regulatory strategy for Oncology products from early development through life cycle management taking into account all relevant guidance, commercial needs and company objectives.

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.

Qualifications

Ph.D., M.D., PharmD. , MS or commensurate experience.

Understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA or other health authorities for drug development and approval.

Understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology.

Direct experience in developing strategy and leading teams through interactions with FDA and other health authorities.

Experience in initiating and conducting successful interactions within FDA or other health authorities.

Ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals.

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