Executive Director, U.S. Regulatory Hematology Lead

General Description: 

The Executive Director, Hematology North America Lead will be responsible for managing a team of NA leaders within the Hematology franchise and supporting the development of North America Strategy across the hematology programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of at least 2 strategist) who are responsible for the regulatory aspects of compounds through all phases of development, post-approval, and life-cycle of the product. The incumbent will provide leadership, guidance and strategic regulatory oversight for the hematology portfolio ensuring that the latest requirements and standards are met while leveraging expedited pathways where appropriate.  

The individual will have regulatory affairs and cross-functional influence within the hematology development portfolio and will act as an advisor/liaison to the NA project leaders and project teams to support the planning, evaluation and recommendation of regulatory strategy. The individual will have extensive experience with the United States FDA, oncology division, leading key interactions including supporting advisory committee (ODAC) meetings, will have had people management experience and a reputation of collaborative approach when interfacing with business partners regarding development, regulatory, and registration strategies. He/she will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies. 

Essential Functions of the job:  

• Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically and operationally to support the development of the hematology portfolio and projects, and regulatory issues to support corporate goals. 

• Provides high level strategic and operational regulatory direction and leadership on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory strategic development plans and risk assessments, critical issue management and advice on FDA interactions. 

• Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission documents in support of clinical trials and marketing applications, and their amendments to support investigational and marketing registration packages within the US and Canada. 

• Supports the NA hematology regional team to negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes. 

• Maintains awareness of the US regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of these regulations. 

• Integrates functional expertise with business knowledge to solve problems and makes good decisions for the overall business. 

• Trains, develops, and manages an effective regulatory team via direct and indirect reporting structure. 

• Builds partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise. 

• Manages critical issues in collaboration with the NA region, taking leadership for the regulatory contribution especially when more than one region is impacted. 

• Responsible for assisting with the development and implementation of regulatory processes. 

• Recruits, develops, manages and mentors regulatory professionals and helps create a goal oriented culture. 

Required Qualifications: 

• BA/BS Degree with 14 plus years of experience in the biotechnical or pharmaceutical industry, and a minimum of 12 years’ experience in a Regulatory capacity with a broad background. 

• Preferred candidates will have extensive experience working with the US FDA in the oncology therapeutic area. 

• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends and able to identify and proactively respond to emerging regulatory trends anticipating future challenges and opportunities in strategy, able to identify scientific and/or clinical advances that impact drug development and regulations. 

• Integrates market needs and prioritization into strategy development. Is considered expert in US FDA strategy development and execution with successful track record including extensive regulatory experience with INDs, NDAs/BLAs, lifecycle management, interactions with US FDA, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record. 

• Strong business acumen and ability to make sound decisions that contribute positively to the business. 

• Strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and opportunities to expedite development and regulatory processes, and the ability to balance short-term needs with long-term vision. 

• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism. 

• Strong people management skills, able to encourage, support and empower a team of NA strategists. 

Required Communication & Interpersonal Skills:  

• Excellent interpersonal, oral and written communication skills. Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders. 

• Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion. 

• Strong negotiating skills and ability to think creatively and develop innovative solutions. 

• Proven ability to build trust and respect within the organization. 

• Ability to prioritize and handle multiple projects simultaneously. 

• Interacts with BeiGene employees and senior management. 

• Interacts with external business partners and Regulatory Agencies. 

Behavioral Competencies: 

Integrity - Ability to demonstrate ethical behavior, understand and comply with legal and regulatory requirements, recognize and resolve unethical behavior or non-compliant situations. 

Global and Strategic Thinking - Able to understand the overall picture, to think and plan holistically in order to develop a NA regulatory position consistent with business needs. 

Managing Relationships and Leading People – Able to develop and foster productive relationships with team members, internal and external partners, and stakeholders. Able to lead people and influence team members across the broader organization including outside of reporting line. 

Driving for Results – Able to break down complex problems, assess risks/opportunities, prioritize and execute tasks in order to solve problems and achieve goals. 

Managing Change and Ambiguity - Ability to learn, adapt, and develop. 

Computer Skills: 

• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) 

• Ability to work on a computer for extended period of time. 

Travel:  

• Must be willing to travel approximately 10-20%.