Sr. Director, Compound Operational Lead(m/w/x)

Requirements

• US work authorization eligibility
• Minimum BA or BS degree
• Advanced degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals) or equivalent medical background (preferred)
• 12-15 years direct experience leading complex global clinical trial programs in pharmaceutical industry
• 5-7 years senior leadership experience directing large-scale global team operations
• Experience developing and mentoring junior/mid-level team members in matrix environment
• Extensive project management experience in diverse settings
• Deep and broad expertise with in-depth knowledge of competitors
• In-depth knowledge of industry challenges and developments
• Ability to identify business opportunities
• Strong leadership competencies
• Influencing skills with senior and cross-functional leaders
• Effective oral and written communication skills
• Ability to influence, inform, and guide large global operational team
• Broad clinical operations experience
• Strong project management skills
• Proven teambuilding skills
• Ability to foster partnerships across projects and multidisciplinary teams
• Comprehensive expertise in drug development
• Profound knowledge of clinical development interfaces and interdependencies

Tasks

• Provide operational oversight and leadership for clinical programs
• Provide strategic input for clinical program planning and execution
• Lead clinical programs from First-in-human to launch
• Drive faster, cost-efficient, patient-centric trials
• Ensure trials meet industry standards
• Apply state-of-the-art project management methodologies
• Align trials with global drug development processes
• Prepare and present operational content for governance discussions
• Provide critical operational input for strategic discussions
• Lead development of clinical operational strategies
• Deliver clinical development plans
• Ensure plans meet budget, timeline, and quality standards
• Represent GDO within the Global Program Team
• Serve as key GDO operational contact for programs
• Contribute to developing annual program objectives
• Communicate objectives to line management
• Drive and lead execution of global clinical programs
• Oversee, review, and deliver quality program CAPAs
• Ensure CAPAs meet corporate compliance and timelines
• Provide expert leadership for program budget operations
• Oversee individual trial budgets and forecasts
• Ensure adherence to R&D financial standards
• Review and provide input on clinical trial documents (e.g., protocols, CSRs)
• Contribute to and review compound level documents (e.g., Investigator Brochures, DSURs, briefing books)
• Provide guidance and leadership to Global CTLs and cross-functional members
• Filter, prioritize, analyze, and validate complex information
• Respond to technical and organizational challenges
• Support department initiatives and provide input on SOPs, processes, and workstreams
• Manage large, complex projects
• Lead diverse project teams
• Ensure successful project execution and organizational learning
• Control sizable resources
• Work independently
• Define team organization, roles, responsibilities, and budget
• Contribute to overall program strategic decisions
• Drive clinical operations strategy within teams
• Develop innovative clinical operation strategies, including patient access and feasibility plans
• Serve as subject matter expert for drug development, clinical trial management, regulations, and therapeutic knowledge
• Lead Clinical Operations Teams
• Ensure team performance and results
• Assess and recommend program resource allocations
• Set team member objectives
• Coach and develop employees
• Provide performance appraisal feedback

Work Experience

Education

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