Global Development Lead, Internal Medicine (Sr. Director)

Scorpion Therapeutics; Pennsylvania; On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Relocation support

Bonus target 22.5%

Long-term incentive

Comprehensive health insurance

Paid leave

401(k) with company match

Job summary

Scorpion Therapeutics seeks a Senior Clinical Development leader to guide cross-functional teams in late-stage cardiometabolic assets, designing development plans and global submissions. The role shapes target product profiles and strategic decisions, including pediatric study plans and international regulatory considerations.

Strong leadership and communication are essential for success. Responsibilities include endorsing plans, ensuring timely delivery, and coordinating submissions with safety

Qualifications

• BS with 12 years or PhD with 7 years relevant clinical/industry experience.
• Experience leading cardiometabolic late-stage development (incl. type 2 diabetes).
• Deep knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.

Responsibilities

• Lead cross-functional Clinical Development Team for Internal Medicine/R&D assets; design, execute, and interpret studies supporting worldwide regulatory submissions.
• Create and gain endorsement for Clinical Development Plan and associated protocol design documents; ensure delivery aligned to timelines/budget.
• Accountable for clinical development plan for global approval/reimbursement (incl. China/Japan) and pediatric investigation plan/study plan.
• Provide product/program input for target product profiles; drive innovative/bold clinical development decisions.
• Develop enabling strategies (digital/innovation and patient engagement).
• Partner with trial clinicians on governance reviews and provide category/therapy-area expertise (CRF design, signal interpretation, adverse event contextualization).
• Support trial-level statistical analysis plan, TLFs/table-listings-figures, and database release (with statistics/programming).
• Develop submission deliverables (IAP/IARP/submission TLFs) including SCE/SCS; review/approve submission safety narrative plan; support label development/maintenance.
• Support regulatory submission deliverables (DSUR, PBRER) including product defense; ensure compliance with SOPs and regulatory standards.

Skills

Leadership

Cross-functional leadership

Clinical development

Regulatory knowledge

ICH/GCP

Adverse event management

Team building

Communication

Education

Bachelor's degree in a relevant field

PhD in a scientific field

Job description

Responsibilities:

• Lead cross-functional Clinical Development Team for assigned Internal Medicine/R&D assets; design, execute, and interpret studies supporting worldwide regulatory submissions.
• Create and gain endorsement for Clinical Development Plan and associated protocol design documents; ensure delivery aligned to timelines/budget.
• Accountable for clinical development plan for global approval/reimbursement (incl. China/Japan) and pediatric investigation plan/study plan.
• Provide product/program input for target product profiles; drive innovative/bold clinical development decisions.
• Develop enabling strategies (digital/innovation and patient engagement).
• Partner with trial clinicians on governance reviews and provide category/therapy-area expertise (CRF design, signal interpretation, adverse event contextualization).
• Support trial-level statistical analysis plan, TLFs/table-listings-figures, and database release (with statistics/programming).
• Develop submission deliverables (IAP/IARP/submission TLFs) including SCE/SCS; review/approve submission safety narrative plan; support label development/maintenance.
• Support regulatory submission deliverables (DSUR, PBRER) including product defense; ensure compliance with SOPs and regulatory standards.

Qualifications/Requirements:

• BS with 12 years or PhD with 7 years relevant clinical/industry experience.
• Experience leading cardiometabolic late-stage development (incl. type 2 diabetes); success in academic and/or biopharma clinical R&D.
• Deep knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.

Preferred/Additional Skills:

• Proven ability to manage/train large teams; demonstrated leadership in designing/launching large teams.
• Strong verbal/written communication; influence in complex matrix environments; accountability and conflict management.

Benefits (explicitly stated):

• Relocation support
• bonus target 22.5% and access to long-term incentive
• comprehensive health, paid leave, and 401(k) with company match (plus additional retirement contribution)