Clinical Development Trial Lead Assoc Dir

Clinical Development Trial Lead Assoc Dir requires:

• Stamford, CT or Indianapolis, IN
• 5+ years clinical research experience or relevant experience in a scientific or health-related field
• Experience with oncology (early & late phase clinical trials)
• Applied knowledge of project management methodology, processes and tools
• Demonstrated ability to lead and work effectively cross-culturally with global colleagues and with TPOs
• Be recognized as a leader with demonstrated ability to coach others in process expertise.
• Embrace strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered priorities
• Ability to influence without authority
• Previous experience working in cross-functional teams/ projects and/or ability to establish and maintain relationships Effective and influential communication, self-management, and organizational skills
• Demonstrated ability to handle complex situations through problem-solving, critical thinking and navigating ambiguity Other Information/Additional
• Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process
• Prior clinical trial site-level or affiliate experience
• Prior experience with local/country regional requirements
• Strong analytical skills Proficiency in use of project management tools and techniques (e.g., Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI)
• Need to travel periodically to scientific/regional meetings
• Associate Director, Clinical Development Trial Lead (CDTL)
• Clinical Trial Process Leadership and Expertise
• Leverage and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise in order to influence study design and program-level decisions considering regional needs.
• Recognize inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise across functional teams, regions, and external partners and make decisions on process and issues affecting study implementation and execution.
• Be knowledgeable on the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams.
• Project Management, and Regional Operational Knowledge

DUTIES:

• Broader responsibilities at Therapeutic Area/ Molecule/Indication level (e.g. attending relative critical chain network builds, providing input on strategy).
• Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials (CT) as described:
• Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make adjustments and changes (per change control process) as needed to meet the deliverables of the trial.
• Timeline – Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies.