Director Clinical Development, Medical Monitor

Computer Skills

• Skilled in Microsoft Office Suite

Other Qualifications

• M.D. with relevant medical experience in Oncology area required. Academic/teaching background is a plus.
• Can effectively contribute to development of disease strategies.
• 5+ years pharma/biotech industry experience OR is a recognized expert in the field.
• 5 years experience with clinical trials, Oncology trials preferred.
• Strong orientation to teamwork.
• Clinical leadership: is regarded as an expert in his/her field, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results.
• Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such.
• Outstanding communication skills, both written and verbal.
  

Global Competencies

• 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

Clinical Development Planning

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s).
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects.
• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups.
• May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance.
• Responsible for creating and implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs together with CST and other relevant teams.
• Communicates with HAs, as and when needed, or otherwise appropriate. Ethically, effectively and professionally represents the interests of BeOne and patients.

Clinical Development Plan Implementation

• Provides clinical oversight across all relevant studies and programs; leads and/or otherwise participates in ongoing TT and relevant study team meetings, other interactions and communications.
• Designs and develops clinical studies; collaborates with others in the development of the product safety profile and clinical sections of investigator brochures, presentations and other materials.
• May participate in the identification and selection of appropriate external investigators and sites.
• Ensures investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study. Acts as a medical monitor for assigned studies.
• Conducts ongoing reviews of medical/safety data.
• Collaborates with relevant teams and other groups to measure and monitor study progress against objectives, proactively communicate any issues, challenges and potential strategies to resolve such.
• Collaborates with other groups to ensure timely and appropriate completion of interim and final study reporting; accountable to ensure correct medical/scientific data interpretation for interim and final study reporting.
• Plays a lead role in the development and implementation of communications strategies to support existing and concluded studies, including KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials.
• Works with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes.
• Develops and delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities.
• Drives ongoing data generation to address unmet medical needs and recommend new or extended CD studies or other programs to his/her manager and others in the relevant therapeutic area of assignment.
• Completes and/or leads other special projects, as and when assigned, or otherwise requested.
• Consistently complies with, and ensures the same among relevant CST members, all governing laws, regulations, BeOne Standard Operating Procedures (SOPs) and other guidelines.

• Medical

• Dental

• Vision

• 401(k)

• Paid Time Off

• Annual bonus plan

Travel

• Up to 20%. Ability to travel domestically and internationally.