Senior Scientist, Clinical Research

Scorpion Therapeutics; Pennsylvania; On-site; USD 120,000 - 170,000; Full time

Job summary

Scorpion Therapeutics seeks an Early Clinical Scientist to coordinate design, planning, and execution of early phase trials. You will manage internal and external teams, ensure safety and data integrity, and contribute to regulatory submissions.

The role requires strong writing and regulatory knowledge, with experience in handling complex trials under accelerated timelines. Collaborations across functions are essential to drive programs forward.

Qualifications

• 3+ years as operational clinical scientist or study manager in pharma/biotech clinical research.
• Knowledge from program planning through regulatory submission; ability to learn therapeutic areas quickly.
• Manage complex operations under accelerated timelines.
• Scientific/medical/safety writing and reporting (at least one).
• Partner with internal/external teams; strong collaboration/leadership/communication/issue resolution.
• Knowledge of GCP, ICH, and regulatory requirements.

Responsibilities

• Coordinate design, planning, and execution of early phase trials with Clinical Director.
• Oversee trials within/across programs to ensure execution and data validity.
• Manage internal/external team performance; resolve project issues.
• Ensure clinical safety assessment and risk management; provide real-time oversight.
• Review and interpret trial data; may conduct on-site monitoring and site training.
• Apply GCP, ICH, and regulatory requirements for development.
• Represent Early Stage Development on cross-functional teams; develop SOPs and procedures.
• Co-author protocols, investigator brochures, clinical study reports, and monitoring plans.

Skills

Clinical trial planning

Regulatory knowledge

Cross-functional leadership

GCP/ICH compliance

Medical writing

Education

Life Sciences degree

Clinical trial mgmt experience

Job description

Early Clinical Scientist (ECS)

Responsibilities

• Coordinate design, planning, and execution of early phase clinical trials with Clinical Director and internal/external teams; oversee trials within/across programs/therapeutic areas to ensure execution/compliance, study objectives, and data validity.
• Manage internal/external team performance; resolve project performance issues.
• Ensure clinical safety assessment and risk management; provide real-time oversight to identify/mitigate patient, study design, data, or conduct issues.
• Review and interpret clinical trial data; may conduct on-site monitoring, including site training and supervision of complex/novel endpoint or biomarker collection.
• Apply GCP, ICH, and regulatory requirements for clinical development.
• Represent Early Stage Development on cross-functional teams; develop/improve job aids/SOPs/procedures and promote adoption.
• Co-author clinical documents (protocols, investigator brochures, clinical study reports, WMA/CTD sections, safety/agency updates), and develop study operational documents (e.g., monitoring plan, study operations manual, informed consent).
• Manage trial/program projects, team activities, and risk/contingency planning under accelerated timelines.

Education

• Degree in Life Sciences; or Bachelor's + 6 years, Master's + 4 years, or PhD/doctorate + 2 years (clinical trial management/execution; site training/monitoring; medical/regulatory writing).

Required Skills/Experience

• 3+ years as operational clinical scientist or study manager in pharma/biotech clinical research.
• Knowledge from program planning through regulatory submission; ability to learn therapeutic areas quickly.
• Manage complex operations under accelerated timelines.
• Scientific/medical/safety writing and reporting (at least one).
• Partner with internal/external teams; strong collaboration/leadership/communication/issue resolution.
• Knowledge of GCP, ICH, and regulatory requirements.

Preferred

• Global Phase I trials, safety reporting, and regulatory WMA submission experience.
• Immunology and/or vaccine trial experience.