Global Clinical Program Lead, Late Respiratory & Immunology

Regulatory Jobs; Gaithersburg (MD); On-site; USD 288,000 - 432,000; Full time

Benefits offered by this job

401(k) retirement plan

Health benefits (medical, prescription

Paid vacation and holidays

Equity-based long-term incentive

Job summary

Regulatory Jobs is seeking a Global Clinical Program Lead to advance late respiratory and immunology programs. You will supervise a team of Global Development Medical Directors and collaborate across functions to design, conduct, monitor and interpret complex studies.

You will ensure data supports benefit-risk decisions for global markets. You will lead the program strategy, interact with health authorities, and guide publication plans while maintaining high ethical standards and regulatory

Qualifications

• MD, PhD or equivalent medical/scientific qualification.
• 5-8 years of relevant clinical development experience.
• Experience in clinical development and cross-functional teams.
• Knowledge of biostatistics, global regulatory requirements, pharmacovigilance, GCP, and trial safety.
• Strong analytical, problem-solving, teamwork, and influencing skills.
• Excellent written and verbal English communication skills.
• Strong presentation and stakeholder engagement capabilities.
• Ability to travel globally.

Responsibilities

• Clinical, scientific, and ethical oversight of studies in compliance with Good Clinical Practice.
• Scientific medical input to study documents and risk-based monitoring plans.
• Scientific medical content at international investigator meetings and support to country activities.
• Safety surveillance on study/program level including AE reporting.
• Reviews of Clinical Study Reports and contribution to key sections.
• Induction and education of new Global Study Team members.
• May contribute to trial improvement workstreams for Clinical function.
• Identify risks and propose mitigation strategies to deliver successful studies.
• Delivery of clinical, scientific, and medical information to Regulatory Agencies and investigators.
• Represent the program at health authority interactions and publications.
• Co-leads study and program strategy for publications with GCH.
• Line management of project study physicians and scientists.

Skills

MD/PhD or equivalent

Cross-functional collaboration

English communication

Analytical skills

Problem-solving

Presentation skills

Travel readiness

Education

MD/PhD or equivalent medical qualification

Tools

GCP (Good Clinical Practice)

Job description

Regulatory Jobs is seeking a Global Clinical Program Lead to advance late respiratory and immunology programs. You will supervise a team of Global Development Medical Directors and collaborate across functions to design, conduct, monitor and interpret complex studies.

You will ensure data supports benefit-risk decisions for global markets. You will lead the program strategy, interact with health authorities, and guide publication plans while maintaining high ethical standards and regulatory