Global Clinical Development Strategy Expert

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

Benefits offered by this job

Health benefits

Parental leave

Job summary

Scorpion Therapeutics seeks a Global Clinical Development Strategy Expert to lead clinical development strategy and execution for acne-related vaccines and new targets. You will oversee cross-functional teams across monitoring, data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs, aligning with R&D strategy and regulatory expectations.

The role requires 5–10+ years in vaccine/therapeutics development, familiarity with GCP/ICH, and proven leadership in

Qualifications

• MD specializing in Dermatology, Infectious Diseases, Pediatrics, Internal Medicine, or related field.
• 5–10+ years in clinical development with vaccine/therapeutics experience.
• Experience with GCP/ICH and regulatory submissions.

Responsibilities

• Define and present a strategic clinical development plan aligned with global R&D strategy and regulatory needs for governance endorsement.
• Lead the Clinical Team and cross-functional areas (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs).
• Manage clinical development from early-stage through licensure; provide clinical leadership for evidence generation supporting licensure and commercialization.
• Partner with pharmacovigilance to define safety surveillance processes and design the safety risk management plan.
• Lead preparation of clinical trial documents (protocols, reports), CTD submissions, and interactions with governance bodies, external experts, and competent authorities.
• Ensure operational processes align with Sanofi SOPs and help review/improve existing SOPs.
• Build and maintain networks of internal/external collaborators, opinion leaders, investigators, and competent authorities.

Skills

Immunology background

Dermatology expertise

Infectious diseases

Pediatrics

Internal medicine

Regulatory experience

GCP/ICH knowledge

Leadership skills

English communication

Education

MD or PhD in related field

Job description

Role Summary:

Global Clinical Development Strategy Expert in Global Clinical Development, leading clinical development strategy and execution for clinical trials, primarily in Acne therapeutic vaccine development and New Targets projects.

Key Responsibilities:

• Define and present a strategic clinical development plan aligned with global R&D/franchise strategy and regulatory needs for governance endorsement.
• Lead the Clinical Team and support cross-functional areas (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs).
• Manage clinical development from early-stage through licensure; provide clinical leadership for evidence generation supporting licensure and commercialization.
• Partner with pharmacovigilance to define safety surveillance processes and design the safety risk management plan.
• Lead preparation of clinical trial documents (protocols, reports), CTD submissions, and interactions with governance bodies, external experts, and competent authorities.
• Ensure operational processes align with Sanofi SOPs and help review/improve existing SOPs.
• Build and maintain networks of internal/external collaborators, opinion leaders, investigators, and competent authorities.

Qualifications & Experience:

• MD specializing in Dermatology, Infectious Diseases, Pediatrics, Internal Medicine (or related); or PhD (Biology, Immunology, Pharmacology, or related) with extensive clinical development experience.
• 5-10+ years in clinical development with expertise in vaccine/therapeutics development and clinical strategy (academia, non-profit, government, or industry).
• Experience with GCP/ICH.
• Proven ability to lead transversal teams; strong interpersonal skills.
• Experience with regulatory submissions and interactions with health authorities.

Skills (Preferred/Welcome):

• Background in clinical immunology (welcome).
• Expertise in Dermatology, Infectious Diseases, Pediatrics, or Internal Medicine (preferred).
• Therapeutic vaccine experience, especially dermatology (Acne) and later-stage development (highly valued).
• Excellent English oral/written communication.
• Autonomy, ability to drive change and empower others; work effectively with diverse stakeholders.

Benefits:

• Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave.