Senior Medical Director

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer.

About the role

The Senior Medical Director, Hematology will support BeOne Clinical and Medical Hematology assets by executing clinical development programs and deliverables in partnership across the organization, with external vendors, academicians, and collaboration partners. As a leader, the incumbent will contribute to clinical program strategy, ensuring activities are executed within scope, budget, and timelines. The role will help establish and grow Clinical Research functions to ensure best-in-class global capabilities and execution. The incumbent will collaborate closely with teams in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research.

Responsibilities

• Facilitate generation of, author, update, and/or review key documents, including:
  • Protocol concepts, synopses, protocols, and amendments
  • Informed consent documents
  • Investigator Brochures
  • Clinical study reports
  • Abstracts, posters, and manuscripts
  • Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
  • Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports
  • Risks/benefits analysis for applicable documents
  • Clinical Development Plans
• Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies.
• Provide scientific expertise for the selection of investigators and vendors.
• Train BeOne colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol.
• Provide scientific and medical support throughout the conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs.
• Review, query, and analyze clinical trial data.
• Interpret and present clinical trial data both internally and externally.
• Represent a clinical study or development program on one or more teams or sub-teams.
• Create clinical study or program-related slide decks for internal and external use.
• Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings.
• Contribute to or perform therapeutic area/indication research and competitor analysis.
• Build strong relationships with internal experts.
• Identify continuous process improvement opportunities.
• Identify incremental organizational resource needs—staff, budget, and systems.
• Develop, track, execute, and report on goals and objectives.
• Support budget planning and management.
• Be accountable for compliant business practices.

Requirements

• 6+ years of experience within biotech/pharmaceutical companies or relevant academic credentials.
• Advanced degree (MD or MD equivalent) with subspecialty training in hematology/oncology (preferred).
• Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e., from start-up to study report), ideally having taken at least one study through from start to finish in a clinical scientist role.
• Clinical oncology experience; candidates with exceptional experience in other therapeutic areas may be considered if they demonstrate clear potential to apply their existing skills to oncology.
• Expert understanding of global clinical study design and the 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.
• Strategic leader with demonstrated success building, managing, and developing individuals and teams (preferred).
• Experience with the development and support of related SOPs and policies.
• Knowledge of industry-standard Clinical Development IT solutions.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, we help get more affordable medicines to more patients around the world. The following competencies are essential:

• 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

Pay

Salary range: $299,800.00 - $369,800.00 annually. Actual compensation is determined by several factors unique to each candidate, including job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible for an incentive compensation plan.

Benefits

• Comprehensive benefits package including Medical, Dental, and Vision.
• 401(k) retirement plan.
• FSA/HSA options.
• Life Insurance.
• Paid Time Off.
• Wellness programs.
• Discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan.