Senior Associate, Clinical Development Trial Lead; CDTL

Purpose

The Clinical Development Trial Lead (CDTL) Associate leads cross-functional study teams to develop and execute clinical trials; accountable regionally and globally to deliver quality, on-time, within-scope and within-budget trial(s.

• Understand trial scope; monitor status and implement changes via change control to meet deliverables.
• Timeline: develop and track global milestones with alignment across functions/geographies.
• Risk: assess/identify/monitor trial-level risks and create an integrated mitigation/contingency plan.
• Budget: manage trial-level grants/non-grants and assumptions using financial tracking tools.
• Coordinate ISSTs/ASTs/Investigator Engagement Meetings with partner organizations.
• Lead/coordinate study teams through implementation, execution, and closure (issue management, contingency planning, issue resolution).
• Own trial/regional enrollment strategy from country allocation through Last Patient Entered Treatment (LPET); partner to achieve enrollment goals.
• Serve as single point of contact for trial communication with Clinical Design and Delivery, cross-functional teams, and Third Party Organizations (TPOs).
• Apply problem-solving to daily cross-functional/vendor/regional/global issues; identify trends for continuous improvement.
• Manage TPO qualification, selection, and oversight.
• Lead clinical trial process activities: drug development process understanding, operating model/regional input, Trial Master File accountability, proactive risk reduction, and coaching.
• Apply GCP/global/regional regulations and local regulatory requirements in conduct of trials.

• Provide technical consultation for clinical/regulatory documents and regulatory meetings; draft responses to questions.
• Apply clinical trial operational/process expertise to design, feasibility, implementation, and execution.

• Bachelor’s degree (scientific/health-related preferred) OR advanced degree.
• 3+ years clinical research or relevant clinical trial experience OR advanced degree.
• Authorized to work in the U.S. on a full-time basis; no visa sponsorship/support.

• Immunology therapeutic experience.
• Trial execution methodology/process/tool knowledge.
• Cross-cultural experience with global colleagues and TPOs; influence without authority.
• Strong leadership, networking, communication, self-management, organization.
• Problem-solving, critical thinking, ambiguity navigation; flexibility to adjust priorities.

• Periodic travel to AST/ISST/Investigator Engagement meetings and potentially other symposiums.

• Company-sponsored 401(k); pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance/death benefits; time off/leave; well-being benefits (e.g., EAP, fitness, clubs/activities).