Global Immunology Clinical Program Lead

Biopharma Careers; Cambridge, Northern (MA, KY); On-site; USD 288,000 - 432,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Equity-based incentive program

Paid vacation and holidays

Job summary

Biopharma Careers is seeking a Global Clinical Product Leader in Immunology to provide medical and scientific input across small molecules, biologics or cell therapy programs in late-stage development. You will drive cross-functional activities, shape development plans, and ensure studies meet regulatory expectations.

The role requires an MD/MD-PhD with 5+ years of pharma experience, strong communication, and leadership of global study teams, with a commitment to patient safety and ethical

Qualifications

• Medical degree (MD or MD-PhD) required with specialty in gastroenterology/gastrointestinal diseases and/or clinical immunology.
• Minimum of 5 years in pharma industry, with experience leading clinical trials to support approval (Phase 2-4).
• Knowledge of biostatistics, global regulatory environment, and pharmacovigilance relevant to the role.
• Experience leading or reviewing a clinical program to support an indication: design, development plan, and Target Product Profile.

Responsibilities

• Provide medical and scientific input into programs of small molecules, biologics or cell therapy for clinical stage assets.
• Lead governance interactions and co-lead study/program strategy for publications.
• Accountable for safety surveillance and for documents like protocol, SAP, informed consent, CSRs.
• Deliver clinical, scientific, and medical information to Regulatory Agencies, Ethics Committees, MCs and investigators.
• Induction and education of new Global Study Team members.

Skills

Clinical trial leadership

Regulatory knowledge

Biostatistics understanding

Cross-functional collaboration

Presentation skills

Education

MD or MD-PhD

Job description

Biopharma Careers is seeking a Global Clinical Product Leader in Immunology to provide medical and scientific input across small molecules, biologics or cell therapy programs in late-stage development. You will drive cross-functional activities, shape development plans, and ensure studies meet regulatory expectations.

The role requires an MD/MD-PhD with 5+ years of pharma experience, strong communication, and leadership of global study teams, with a commitment to patient safety and ethical