Senior Associate, Clinical Development Trial Lead (CDTL)

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

401(k)

Pension

Health, dental, vision

Life insurance

Job summary

Scorpion Therapeutics in Indianapolis seeks a Clinical Development Trial Lead Associate to guide cross-functional study teams through clinical trials, ensuring quality, on-time delivery and regulatory compliance.

You will own enrollment strategies, manage budgets, and coordinate with ISSTs/ASTs and third parties, applying GCP and global/regional regulations while advancing drug development.

Qualifications

• Bachelor’s degree (scientific/health-related preferred) or advanced degree.
• 3+ years clinical research or trial experience.
• Authorized to work in the U.S. on a full-time basis; visa sponsorship not offered.

Responsibilities

• Lead cross-functional study teams to develop and execute trials.
• Monitor scope, timeline, and budget; implement changes via change control.
• Develop global milestones with alignment across functions/geographies.
• Assess trial risks and create integrated mitigation plans.
• Coordinate ISSTs/ASTs and Investigator Engagement Meetings.
• Oversee enrollment strategy from country allocation through LPET.

Skills

Immunology

Trial execution

Leadership

Communication

Education

Bachelor’s degree

Advanced degree

Job description

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.

Primary Responsibilities

• 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.

Scientific Expertise

• 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.

Minimum Qualifications

• 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.

Highly Desired Skills

• 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.

Additional Preference

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

Benefits (if eligible)

• 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).