Global Development Lead, Internal Medicine (Sr. Director)

Scorpion Therapeutics; Tampa (FL); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior leader to drive worldwide clinical development programs for internal medicine assets. You will guide cross-functional teams, shape development plans, and ensure regulatory readiness across lifecycle stages.

You will oversee pediatric strategy, contribute to product profiles and regulatory documents, and engage with trial clinicians, boards, and regulators to optimize safety and efficacy outcomes. Travel up to 30% may be required.

Qualifications

• BS with 12+ years of industry experience or PhD with 7+ years in clinical development.
• Proven track record leading large development teams and cross-functional programs.
• Extensive knowledge of global regulatory frameworks (ICH/GCP) and submissions.

Responsibilities

• Lead cross-functional Clinical Development Team for assigned internal medicine assets and drive clinical strategy and interpretation for worldwide regulatory submissions.
• Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across study lifecycle.
• Lead/oversee pediatric investigation plan/study plan and protocol design for pediatric feasibility and optimized execution.
• Provide input to target product profiles and regulatory deliverables (e.g., product labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
• Partner with trial clinicians on governance reviews; provide category strategy and therapy area/indication expertise (CRF design, signal interpretation, AE contextualization).
• Support trial statistical analysis plan (tables/listings/figures, database release) and submission-level deliverables (IAP, IARP, submission TLFs; SCE, SCS, safety narrative plan).
• Support medical monitoring (if required), external stakeholder engagement (Ad boards, Steering Committees, DMC, adjudication committees, patients/advocates), product label development/maintenance, and regulatory disclosure and product defense.

Job description

Responsibilities

• Lead cross-functional Clinical Development Team for assigned internal medicine asset(s); accountable clinical point for design, execution, interpretation of studies supporting worldwide regulatory submissions.
• Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across study lifecycle.
• Lead/oversee pediatric investigation plan/study plan and protocol design for pediatric feasibility and optimized execution.
• Provide input to target product profiles and regulatory deliverables (e.g., product labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
• Partner with trial clinicians on governance reviews; provide category strategy and therapy area/indication expertise (CRF design, signal interpretation, AE contextualization).
• Support trial statistical analysis plan (tables/listings/figures, database release) and submission-level deliverables (IAP, IARP, submission TLFs; SCE, SCS, safety narrative plan).
• Support medical monitoring (if required), external stakeholder engagement (Ad boards, Steering Committees, DMC, adjudication committees, patients/advocates), product label development/maintenance, and regulatory disclosure and product defense.

Basic Qualifications / Requirements

• BS with 12 years or PhD with 7 years relevant clinical/industry experience.

Experience

• Lead cardiometabolic late-stage development (including type 2 diabetes); track record in academia/biopharma clinical R&D.
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
• Demonstrated clinical/medical, administrative, and project management; effective communication.
• Manage and train large clinical development teams; designing/launching large teams preferred.

Competencies (high level)

• Medical/scientific excellence; matrix leadership and influence; leadership and conflict management; team building; accountability; adaptability.

Other

• Up to 30% travel may be required.