Associate Director Clinical Operations

About the Role

The Associate Director, Clinical Development Trial Lead (CDTL) independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within Product and budget.

Responsibilities

• Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials (CT) as described:
• Product - Understand the Product 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 Producting alignment and integrating inputs across functions and geographies. Provide consultation and guidance to CDTLs on their integrated plans.
• Risk - Assess, identify and monitor trial-level risks.
• Budget - Understand the cross-functional, trial-level budget components. Create and monitor the budget grants and non-grants, and assumptions using financial tracking tools. Routinely network with appropriate business partners on trial-level budget status and changes. Function as point of contact for other CDTLs on their clinical team as needed regarding budget items.
• Lead, influence and project manage large, complex studies and/or multiple smaller studies.
• Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).
• Independently drive and influence local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including proactive issue management, contingency planning and issue resolution.
• Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET).
• Partner with the Regional Operations to achieve regional enrollment goals.
• Anticipate and resolve complex and key technical operational or business problems with cross-functional study team (including vendors, affiliates/regions, global team members, and other business partners) with little to no need for direct management support. Evaluate and identify issues that require escalation.
• Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
• Use expertise to make timely decisions for ambiguous and complex situations.
• Manage TPO (third party organization) qualification process, selection, and oversight.
• Serve as the CRO (Clinical Research Organization) clinical development point of contact for outsourced and fully outsourced trial execution. Ensure CRO delivery of project milestones.

Qualifications

• Bachelor's degree (scientific or health-related field preferred)
• 5+ years clinical research experience or relevant experience in a scientific or health-related field

Required Skills

• 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

Preferred Skills

• 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