Global Clinical Program Lead, Immunology (Hybrid)

CSL Plasma; Waltham (MA); Ibrido; USD 300.000 - 376.000; Tempo pieno

Descrizione del lavoro

CSL Behring in Waltham, MA offers two Medical Director, Global Clinical Program Lead positions aligned to Immunology and Immunoglobulin. This hybrid onsite role requires leading clinical development plans and cross-functional teams to drive strategic program execution.

Responsibilities include developing CDPs, due diligence support, and regulatory alignment with GCP/ICH; competitive compensation includes a base salary in the stated range with potential incentives and equity.

Competenze

• MD, PhD or PharmD in life science/healthcare.
• MD - Board Certified (or non-USA equivalent) preferred.
• Extensive clinical development pharma/biotech experience with regulatory knowledge.
• 3+ years of relevant clinical development experience.
• Demonstrated program leadership in a matrix environment.
• Stakeholder management including risk mitigation.
• Proficient in project management terminology and processes.
• Analytical thinking and scientific/medical writing skills.
• Proficient in clinical data analysis and interpretation.
• Strong communication and presentation skills; cross-functional collaboration.

Mansioni

• Business Development & Clinical Support for Internal Pre-Clinical Assets.
• Serve as clinical representative on due diligence teams; prepare CDPs and slides.
• Develop high-level target product profiles for pre-clinical assets.
• Create CDPs for internal assets and present at development stage gates.
• Provide CDT leadership and align with PST and TALT.
• Ensure regulatory compliance (GCP/ICH) and maintain CDP.
• Lead medical monitoring and provide regulatory support.
• Present results to safety and governance committees.

Conoscenze

Clinical leadership

GCP/ICH knowledge

Medical writing

Data analysis

Regulatory familiarity

Cross-functional collaboration

Project management

Communication skills

Formazione

MD/PhD/PharmD

Descrizione del lavoro

CSL Behring in Waltham, MA offers two Medical Director, Global Clinical Program Lead positions aligned to Immunology and Immunoglobulin. This hybrid onsite role requires leading clinical development plans and cross-functional teams to drive strategic program execution.

Responsibilities include developing CDPs, due diligence support, and regulatory alignment with GCP/ICH; competitive compensation includes a base salary in the stated range with potential incentives and equity.