Director, Global Medical Affairs, Sponsored Phase IV Studies
Remote (US), United States
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.
General Description:
- Work with country or global teams to plan and implement Phase IV GMA-sponsored clinical trials, interventional or non-interventional
- This includes all aspects of study management and oversight, including working with the CRO, engaging with non-GMA stakeholders for alignment, project management, data management, safety planning, etc.
Essential Functions of the job:
- Create the global governance structure and implementation process for these studies.
- Build capabilities and infrastructure for GMA-sponsored studies; interventional and non-interventional.
- Build the templates, tracking and reporting process for these studies for leadership and non GMA members.
- Create a global Sharepoint site to house all required documents and oversee all data is added to the appropriate systems (GMA portal, ClinOps portal).
- Work with the responsible party (eg Country Medical Director, HEOR lead) to create the implementation and operations plan for a GMA-sponsored study.
- Create the governance structure and planning forum for each study.
- Manage and track study-specific activities and deliverables.
Education Required:
- Master's or Doctorael level degree required.
Qualifications:
- Master's or Doctorate level degree with 10 + years of experience in the pharmaceutical industry.
- 5 + years of experience in managing company-sponsored clinical trials within the pharmaceutical industry.
- Preferred: Experience conducting post-marketing company-sponsored trials (interventional & non-interventional).
Experience managing a CRO, understanding of global regulatory requirements for company-sponsored trials.
Detail-oriented, organized, excellent written & verbal communication skills.
Able to function in a fast-paced environment, self-directed.
Supervisory Responsibilities:
- Yes
Computer Skills:
- Excel, PowerPoint, Project Management Software, Smartsheet, data management databases (eg CTMS), Veeva or similar.
Travel:
- <10%
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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
BeiGene 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 BeiGene 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.
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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Annual bonus plan Continuous learning Dental Discretionary equity awards Employee stock purchase plan Equity awards FSA FSA/HSA Global competencies HSA Incentive compensation plan Life Insurance Medical Paid Time Off Vision Wellness
Tasks- Create governance structure
- Data Management
- Manage study oversight
- Plan and implement phase IV studies
- Project management
- Training
Analysis Analytical Analytical thinking Clinical Clinical trials Communication CTMS Data analysis Data Management Employee stock purchase plan Entrepreneurial Mindset Excel Financial excellence Global Regulatory Requirements Governance Initiative Leadership Marketing Medical Affairs Pharmaceutical Pharmaceutical Industry Planning PowerPoint Project Management Regulatory Regulatory requirements Reporting Safety SharePoint Smartsheet Study Management Teams Teamwork Training Veeva
Experience10 years
EducationBusiness Doctorate Master Master's Operations
Certifications TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9