Executive Director, Global Medical Affairs, Breast Disease Area Lead

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne 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.

The Executive Director Breast/Women’s Disease Area Lead, GMA, will support BeOne Medicine's Clinical and Medical assets by successful execution of Global Medical Affairs program as well as Clinical Development strategy and key deliverables. The candidate will report to the Vice President, Global Medical Affairs.

As a leader in the organization, the incumbent will be involved in developing and executing the Breast/women’s cancer clinical program strategy and help assure that activities are executed within expected scope, budget and timelines.  The incumbent will work closely with colleagues in global medical affairs, clinical development, program leadership, biometrics, clinical operations, and translational research. 

Essential Functions of the job:

• Develop, lead, and oversee the execution of a Breast and women’s Cancers Disease Area Global Medical Affairs Plan.
• Develop and execute on a data generation strategy outside of the clinical development program, including investigator -initiated programs and real world evidence programs. 
• Represent Medical Affairs in early development and clinical development team meetings with a focus on contributing regional and global medical input to the clinical development plan, clinical trial design, and support successful implementation of the clinical program. 
• Influence and support development of disease and product specific Clinical Development strategy within breast/women’s cancers. 
• Lead with the scientific communications team on a successful Disease Area publication strategy and implement successful publication plan including review and approval of relevant abstracts and manuscripts.
• Lead and work cross-functionally with Clinical Development on disease area advisory meetings.
• Interpret, and present clinical trial data both internally and externally.
• Partner with the Health Economics and Outcomes Research Team in providing technical and clinical expertise on relevant disease area evidence generation studies. 
• Executive Disease Area Global Medical Facilitate generation of, author, update, and/or review.
• Train BeOne colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocols.
• Contribute to or perform therapeutic area/indication research and competitor analysis.
• Lead and execute relevant Advisory Boards.
• Build and maintain strong relationships with key opinion leaders and institutions globally.
• Build strong alliances and relationship with internal experts. 
• When appropriate be the GMA representative at Alliance partnerships.
• Develop, track, execute and report on goals and objectives.
• Support budget planning and management.
• Be accountable for compliant business practices.

Required Experience:

• Advanced degree (MD, PharmD, PhD, or MD equivalent) with subspecialty training in oncology.
• Extensive experience in pharma/biotech specifically in breast cancer therapeutics is preferred. 
• 10 plus years of experience within other biotech/pharmaceutical company, or equivalent experience.    
• Clinical breast cancer therapeutic experience is mandatory for this role.  
• Previous experience in Clinical Development  in the role of medical director, clinical scientist, or breast cancer oncologist role is strongly preferred. 
• Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing.
• High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
• Knowledge of GCP and ICH Guidelines.
• Flexibility to work with colleagues in a global setting.
• Able to engage in work-related travel approximately 25%.
• Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred.
• Experience with the development and support of related SOPs and policies is expected.
• Knowledge of industry standard Clinical Development IT solutions expected.

Capabilities and Competencies:<