Global Clinical Development Strategy Expert

Scorpion Therapeutics; Washington (District of Columbia); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Parental leave

Healthcare benefits

Job summary

Scorpion Therapeutics is seeking an experienced clinical development leader to define and drive the strategic plan from early development through licensure, aligning with global R&D and regulatory needs.

You will lead a multidisciplinary team, integrate data from monitoring, data management, and biostatistics, and coordinate with pharmacovigilance and regulatory affairs to ensure robust evidence generation for licensure and market access.

Qualifications

• MD or PhD with extensive clinical development experience
• 5–10+ years in clinical development with vaccine/therapeutics strategy
• Experience with GCP/ICH guidelines
• Regulatory submissions and health authority interactions

Responsibilities

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

Skills

Clinical leadership

Regulatory strategy

Stakeholder management

GCP/ICH compliance

Cross-functional collaboration

Medical writing

English communication

Education

MD with Dermatology/Infectious Diseases/Pediatrics/Internal Medicine

PhD in Biology/Immunology/Pharmacology

Job description

Key Responsibilities:

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

Qualifications:

• 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 demonstrated vaccine/therapeutics strategy experience.
• Experience working according to GCP/ICH guidelines.
• Proven ability to lead and manage transversal teams.
• Regulatory submissions and health authority interaction experience.

Preferred Skills/Experience:

• Clinical immunology background.
• Expertise in Dermatology, Infectious Diseases, Pediatrics, or Internal Medicine.
• Experience with therapeutic vaccines, especially for acne (and later-stage development).
• Excellent English oral/written communication.
• Autonomy, change leadership, and ability to work with diverse stakeholders.

Benefits (if explicitly stated):

• Rewards package; high-quality healthcare; prevention and wellness programs; at least 14 weeks’ gender-neutral parental leave.