Head, Clinical Development & Operations Quality

Scorpion Therapeutics; New York (NY); On-site; USD 300,000 - 500,000; Full time

Benefits offered by this job

Base salary range

Bonus plan

401(k) with company match

Paid time off

Relocation support

Medical/dental/vision

Job summary

Scorpion Therapeutics seeks a senior GCP quality leader to set and drive the long-term quality, compliance and integrity strategy for CD&O. You will own enterprise quality governance, lead the GCP Oversight Committee, and ensure readiness for pivotal trials and regulatory engagements across a global Phase I–IV portfolio.

You will influence executives on high-stakes regulatory and data integrity risks, shape AI/digital quality frameworks, and advance quality by design across planning, operations,

Qualifications

• 12+ years advanced scientific/medical/pharmacy/regulatory/quality experience (or equivalent).
• Extensive leadership in GCP quality, clinical development/operations, and regulatory compliance; experience directing senior leaders in a global setting.
• Deep expertise in Phase I-IV trial conduct and applying GCP requirements across major jurisdictions.
• Enterprise accountability for quality strategy, clinical quality systems, portfolio risk management, inspections and remediation.

Responsibilities

• Set and execute the long-term GCP quality, compliance and integrity strategy for CD&O.
• Own the enterprise framework to assess, communicate and improve GCP quality state (indicators, audits, risk trends).
• Translate quality intelligence into strategic recommendations for portfolio priorities and capabilities.
• Design and lead a risk-based GCP quality-governance model with clear decision rights and escalation.
• Chair the GCP Quality Oversight Committee and elevate material risks to executive governance.
• Provide strategic oversight across global Phase I-IV portfolio focusing on participant/data integrity/regulatory risk.
• Ensure inspection readiness for pivotal trials/submissions and represent quality in sponsor inspections.
• Lead AI/digital quality frameworks: lifecycle management, explainability, data integrity and regulatory readiness.
• Embed quality by design across planning, protocol, vendor models and technology transformation.
• Establish third-party/GCP risk governance; lead due diligence, contracting expectations and oversight.
• Provide executive leadership for systemic remediation and organizational learning.
• Lead globally distributed quality organization, talent strategy and accountable delivery.

Skills

GCP quality leadership

Clinical development

Regulatory compliance

Executive influence

Quality strategy

AI quality

Governance

Audits & inspections

Cross-functional

Risk management

Quality governance

Job description

Job Responsibilities

• - Set and execute the long-term GCP quality, compliance and integrity strategy for CD&O.


• - Own the enterprise framework to assess, communicate and improve the state of GCP quality (leading/lagging indicators, regulatory expectations, audit/inspection outcomes, quality-event trends).


• - Translate quality intelligence into strategic recommendations for portfolio priorities, operating-model design, capability investment, resourcing and risk acceptance.


• - Design and lead an integrated, risk-based GCP quality-governance model with clear decision rights, escalation thresholds and accountability.


• - Chair the GCP Quality Oversight Committee and elevate material risks and remediation priorities to executive governance bodies.


• - Exercise independent judgment and challenge decisions that could compromise participant protection, data integrity, regulatory compliance, or Pfizer’s ability to defend evidence.


• - Provide strategic quality oversight across the global Phase I-IV portfolio; focus on greatest participant/data-integrity/regulatory/business risk.


• - Ensure inspection readiness for pivotal trials/submissions; act as senior CD&O quality representative in sponsor inspections and regulatory engagements.


• - Lead AI/digital quality: define frameworks for design/validation/deployment/lifecycle management; partner to ensure explainability, data integrity, risk controls and regulatory readiness; modernize quality intelligence with data/AI.


• - Embed quality by design across planning, protocol/operations, vendor models and technology transformation.


• - Establish third-party, CRO/vendor and partner GCP quality strategy; lead risk-based due diligence, contracting expectations and oversight.


• - Provide executive leadership for systemic remediation and organizational learning.


• - Lead globally distributed quality organization, capability/talent strategy, resource/investment prioritization, and a culture of integrity and accountable delivery.

Qualifications / Skills

• - 12+ years’ advanced scientific/medical/pharmacy/regulatory/quality experience (or equivalent).


• - Extensive progressive leadership in GCP quality, clinical development/operations, and regulatory compliance; experience leading senior leaders in a complex global organization.


• - Deep expertise in Phase I-IV clinical trial conduct and application of GCP requirements across major jurisdictions.


• - Demonstrated enterprise accountability for quality strategy, clinical quality systems, portfolio risk management, inspections and complex remediation.


• - Proven ability to advise/influence executives on high-stakes regulatory/participant/data-integrity/reputational/business risk.


• - Demonstrated success transforming organizational/operating models while sustaining quality and compliance.


• - Experience establishing governance/decision rights across matrix organizations and external partner networks.


• - Ability to lead through ambiguity, challenge constructively, make trade-offs, and convert complex quality information into executive decisions.

Preferred Qualifications

• - Direct experience engaging major global health authorities on inspections and evolving GCP expectations.


• - Experience shaping quality strategy for AI/digital/advanced analytics, decentralized or novel trial approaches.


• - Experience with acquisitions/integrations/alliances introducing third-party and GCP quality risk.


• - External industry leadership (forums/standards/thought leadership).


• - Track record building global leadership teams and future-facing capabilities.


• - Strong business/financial acumen (resource prioritization and investment decisions).

Benefits (explicitly stated)

• - Annual base salary: $300,100.00–$500,100.00; Global Performance Plan bonus target 30% of base; share-based long-term incentive eligible.


• - 401(k) with Pfizer matching + additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.


• - Relocation assistance may be available (business needs/eligibility).

Application Instructions

• - Candidates must be authorized to work in the U.S.; U.S. work visa sponsorship is not available for this role (now or in the future).