The Senior Disease Area Lead, GMA, will support BeOne 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, Solid Tumors. As a leader in the organization, the incumbent will be involved in developing and executing gynecologic cancer as well as other future solid tumor 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 gynecologic Global Medical Affairs Plan as well as future other solid tumor plans based on pipeline data advancement.
- 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 thoracic 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 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.
Qualifications and Experience: - Advanced degree (MD, PharmD, PhD, or MD equivalent) with subspecialty training in oncology.
- Extensive experience in pharma/biotech in solid tumors is required.
- 8 plus years of experience within other biotech/pharmaceutical company.
- Clinical solid tumor oncology experience is mandatory for this role.
- 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.
Other Qualifications: - 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.
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Salary Range: $296,600.00 - $376,600.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
