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BeiGene Vice President, Global Safety Operations and Innovation in Topeka, Kansas

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Company Overview:

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 7,700 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients

General Description:

The Vice President, Global Safety Operations and Innovation is a global executive role that provides leadership to drug safety in the areas of PV Operations, international operations, business capabilities and innovation. The incumbent also oversees functional strategy planning and ensures effective development, implementation and execution of processes and standards to ensure patient safety.

Context and Responsibilities:

The Vice President, Global Safety Operations and Innovation Global Patient Safety is a global role, which can be based in Ridgefield Park, NJ, San Mateo, CA, Emeryville, CA or US Remote (West Coast Preferred)

Responsible for:

Pharmacovigilance Operations

  • Global Compliance

  • Quality

  • Standards

  • PV Agreements

  • PSMF Management

  • Inspection readiness & oversight

  • Safety Systems

  • Safety Data Science & Analytics

International Operations

  • Regional & Local Office Governance

  • International Strategy & Excellence

Functional Strategy & Planning

  • Functional Strategy & Planning

  • Budget Management

  • Resource Planning

  • Organizational Development

  • Strategic Projects

  • Contracts Management

Business Capabilities & Innovation

  • Project Enablement

  • PV Innovation

  • PV Intelligence

  • Process Optimization

  • Publications

  • Communications & Change Mgmt

  • Learning & Dev

  • Performance Insight & Reporting

Essential Functions of the Job:

Functional Strategy Planning:

Plans and directs administrative, contractual, financial, and operational activities for drug safety department on behalf of the SVP, Chief Safety Officer. Organizes and prioritizes critical issues and required information for the drug safety leadership team, to facilitate efficient decision making. This capability provides oversight and guidance to drug safety department projects of high importance and supports establishment of goals to support broad functional objectives

PV Operations

(Compliance, Quality, Standards, PV Agreements, PSMF Management, Inspection readiness & oversight):

Ensure that the company’s pharmacovigilance system is enabled with a fully compliant quality management system (QMS) and governed via a GVP compliant PV System master file. Elements of the QMS include but are not limited to the management of compliance, quality, training, standards, PV agreements and inspection oversight/readiness.

PV Operations

(Safety Systems, Safety Data Science & Analytics) :

Ensure that the drug safety department’s scientific evaluations are fully enabled through the provision of safety data science and analytics services to enable rapid synthesis of safety information and generation of insights to support decision making. In addition, ownership of the strategy, implementation and maintenance of the global safety database and associated pharmacovigilance tools in collaboration with corporate IT services.

International Operations:

Establishment of the blueprint and operating model for Regional and Local affiliate drugs safety. Provide governance and ongoing strategic direction into the set up and maintenance of the worldwide drug safety network to ensure effective support for the functioning of the QPPV. Lead strategic imperatives and oversee projects that impact on global and/or international operations

Project Enablement:

Provision of project management services, including development of standards & resources to support the execution of projects globally across drug safety department.

PV Innovation Incubator:

Manage drug safety department innovation roadmap and process which includes business need identification, proof of concept execution, and partnership identification to ensure drug safety department scientific and operational capabilities evolve in keeping with the ever changing healthcare landscape.

PV Intelligence:

Intelligence gathering and communication to inform and prioritize business strategies; includes analysis and contextualization of best practices and trends across industries, emerging regulations and legislation, new technologies, capabilities and partners, as well as internal business needs.

Process Optimization:

Collaboration with drug safety department sub-functions to establish understanding of business processes and business needs, based on data driven insights, in order to improve business outcomes.

Strategic Partnerships:

Management of processes involving strategic partner, vendor, service provider evaluation, identification, initiation and relationship management to enable drug safety department achievement of functional and strategic imperatives.

Publications Management:

Publication strategic planning and management to support scientific evidence generation and dissemination across the industry to inform evidence-based healthcare decision making

Communications:

Development and execution of drug safety department internal and external communication strategies, content assets and multi-channel engagement based on stakeholder needs and business strategies to ensure stakeholder awareness, adoption and advocacy of drug safety department value proposition

Change Management:

Develop change management plans, communications and stakeholder engagement strategies to understand impact of change(s) on people, process, and technology, and enable drug safety department to thrive in periods of change.

Learning & Development:

Delivery of compliance based training in addition to the continuous assessment of professional development/skillset needs across drug safety department to create opportunities for development and staff augmentation to maximize engagement, talent potential and organizational performance.

Performance Insights & Reporting:

Establishment, monitoring and communication of drug safety department key performance indicators to track organizational performance, and areas for improvement.

Key Relationships:

  • SVP, Chief Safety Officer, Global Product Safety

  • Lead Product Safety MDs

  • Post-market and Trials Safety Staff

  • ICSR Management and Medical Review Staff

  • Clinical, Medical Affairs, Regulatory and Commercial Teams

  • Corporate IT and Innovations teams

  • Direct Reports: Global Safety Operations & Innovation Staff

Minimum Requirements – Education and Experience:

  • Bachelors or higher in a relevant scientific discipline

  • Fifteen (15) years relevant experience, including training

  • Ten (10) years industry pharmacovigilance experience

  • Demonstrated track record of safety operations excellence

Other Qualifications:

  • Prior, successful innovation project implementations

  • Global PV Regulatory Requirements

  • IT system design and deployment

  • Demonstrated leadership skills

Supervisory: Yes, Global Team of 40 staff

Travel: 5%

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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