Head, Program and Study Management Oncology

Scorpion Therapeutics; North Wales (Montgomery County); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a senior clinical operations leader to guide the GCTO vision and oversee end-to-end clinical program execution. You will chair cross-functional teams to align R&D and trial delivery with strategic asset objectives.

You will drive AI-enabled operational improvements, mentor global teams, and ensure regulatory readiness for late-stage reviews and inspections. Strong leadership and TA expertise are essential.

Qualifications

• 12+ years progressive pharma/biotech/CRO experience with focus on clinical trial operations/drug development.
• Proven single-point accountability for successful clinical programs including pivotal registrations and regulatory submissions.
• Track record building talent pipelines and developing future directors/program leaders.
• Expertise in designated TA and TA-specific operational challenges.
• Proven digital & AI leadership (AI, automation, predictive analytics).
• Demonstrated financial/operational stewardship and cycle time improvement.
• Strong GCP/ICH and global regulatory knowledge.
• Strong matrix influence and ability to drive alignment across global R&D teams.

Responsibilities

• Contribute to development and execution of GCTO vision, strategy, and goals; align with R&D and GCD strategy.
• Serve as single-point accountability for assigned TA(s); provide operational input into the clinical development plan.
• Translate objectives into actionable operations; guide teams on landscape, rationale, and asset vision.
• Provide end-to-end accountability for planning, execution, and delivery of the clinical program portfolio on time and budget.
• Drive cross-functional trial delivery strategies; assess risk monthly and escalate as needed.
• Ensure execution excellence via process improvements and KPI/KQI measurement across milestones.
• Use predictive analytics and AI-driven insights to mitigate operational risks.
• Act as primary escalation point for complex operational issues; ensure compliance with GCP/ICH and global regs.
• Lead readiness for late-stage reviews, ops reviews, inspections, and audits.
• Provide people leadership for a global team; build talent pipelines and succession planning.
• Champion modernization of clinical trial ops using AI/automation and quality-by-design.
• Manage TA resources (headcount and budget); govern vendor strategies with KPI/KQI oversight.
• Represent the company externally and build/maintain industry network.

Skills

Clinical trial operations

Clinical risk management

Operational excellence

Resource allocation

Stakeholder management

Change management

Innovation

KPI-driven management

Digital leadership

AI leadership

Education

Bachelor's degree in life sciences

Advanced degree (MS/PhD/PharmD)

Job description

Key Responsibilities

• Contribute to the development and execution of GCTO vision, strategy, and goals; ensure alignment with R&D and GCD strategy.


• Serve as single-point accountability for assigned TA(s); provide strategic operational input into the overall clinical development plan.


• Translate scientific/TA objectives into executable operational strategies; guide teams on competitive landscape, scientific rationale, and long-term asset vision.


• Provide end-to-end accountability for operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and to the highest quality standards.


• Drive cross-functional trial delivery strategies; assess trial delivery risk monthly and escalade via forums as needed.


• Ensure execution excellence through continuous process improvement and KPI/KQI measurement across milestone/product delivery; cycle times (FPI, Site Ready 80%, Site Activation, Database Lock); enrollment/retention/data quality; LPI on time/within budget; quality metrics (protocol deviation rate, data/query, issue management, eTMF compliance, CV/org charts, training).


• Use predictive analytics and AI-driven insights to proactively identify/mitigate operational risks.


• Act as primary escalation point for complex operational issues; ensure activities comply with GCP/ICH and global regulations.


• Lead readiness for late-stage reviews, ops reviews, inspections, and audits.


• Provide people leadership for a global team; build talent pipelines, mentorship/education, succession planning, and a culture of accountability and continuous improvement.


• Champion modernization of clinical trial operations using AI/automation and quality-by-design processes.


• Manage TA resources (headcount and budget); drive vendor strategies with KPI/KQI oversight and governance participation.


• Represent the company externally and build/maintain an industry network.

Educational Requirements

• Bachelor’s degree required (scientific discipline strongly preferred).


• Master’s/PharmD/PhD in life sciences/medicine or related field strongly preferred.

Required Experience/Knowledge/Skills

• 12+ years progressive pharma/biotech/CRO experience with primary focus on clinical trial operations/drug development.


• Proven single-point accountability for successful clinical programs (including pivotal registration and regulatory submissions).


• Track record building talent pipelines and developing future directors/program leaders.


• Expertise in designated TA and TA-specific operational challenges.


• Proven digital & AI leadership (AI, automation, predictive analytics).


• Demonstrated financial/operational stewardship and cycle time improvement.


• Strong GCP/ICH and global regulatory knowledge.


• Strong matrix influence and ability to drive alignment across global R&D teams.

Required/Relevant Skills

• Clinical trial operations/management, clinical risk management, operational excellence, resource allocation, stakeholder management/collaboration, change management, innovation, KPI-driven management.