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Sr. Medical Director/ Sr. Scientific Director or Executive Medical Director/Executive Scientific Director, Gastrointestinal - Emeryville, United States - BeiGene
Description
General Description:
The Senior/Executive GI Disease Area Lead, GMA, will support BeiGene 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 GI cancr 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 GI 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 GI 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.
Train BeiGene 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:
For all the roles, the minimum requirement is an advanced degree (MD, PharmD, PhD, or MD equivalent) with 8 plus years of overall experience within other
biotech/pharmaceutical company
and a subspecialty training in oncology.
Extensive experience in pharma/biotech in solid tumors is required.
Clinical solid tumor oncology experience is mandatory for this role.
Industry experience and managerial track record required.
Previous experience in Clinical Development in the role of medical director or clinical scientist 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
Executive presence and ability to influence and lead.
Exceptional cross-functional collaboration within GMA and with other departments.
Accountable and results-driven.
Impactful written and verbal scientific communication.
Problem solving and risk-mitigation skills.
Confident, positive attitude
Flexibility and embracing change
Please note the salary range reflected below is tied to the Senior Medical Director MD role.
Ranges for an Executive Medical Director will be higher, and the ranges for Senior Scientific Director and Executive Scientific DEirector (non MD's) will likley be lower.
All 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.
