Global Clinical Development Strategy Lead

CSL; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

CSL seeks a senior professional to provide scientific input to clinical development strategies across multiple therapeutic areas and programs. You will shape the scientific strategy for clinical development plans, design trial documents, and oversee clinical trial science.

Role requires leadership in developing Clinical Development Program, authoring study documents, contributing to publications, and mentoring project teams, with close collaboration across departments.

Qualifications

• Bachelor's degree or equivalent in Science, Allied Health or Engineering.
• 8+ years experience in the biotechnology or pharmaceutical industry.
• 5+ years managing projects.
• In-depth knowledge in the drug development and manufacturing processes for pharmaceuticals (CMC, non-clinical, clinical, Regulatory Affairs).

Responsibilities

• You will be responsible for scientific input to clinical development strategies and therapeutic areas.
• Provide scientific and clinical development input for the safe and efficient execution of assigned programs, ensuring the highest quality and full compliance of all outputs.
• Will contribute to the development of the scientific strategy of the clinical development plan, the design of trial related documents and the scientific oversight of clinical trials.
• You will facilitate a team to define and deliver the clinical strategy within programs.
• Define scientific strategy for multiple program components.
• You will lead the development of Clinical Development Program.
• Author clinical study documents and assists with development/critical review of submission documents.
• Contribute to authorship and review of manuscripts and conference abstracts.
• Collaboratively develop the clinical development strategy with project teams, providing input, guidance and mentorship for project teams.
• Contribute to the scientific analysis and interpretation of clinical data and the writing of clinical study reports, internal and external scientific meeting presentations and peer-reviewed publications, and all regulatory submission documents.
• Will foster close collaboration with other departments, defining and improving interfaces to other departments.

Skills

Project management

Cross-functional collaboration

Education

Bachelor's degree or equivalent in Science, Allied Health or Engineering

Job description

CSL seeks a senior professional to provide scientific input to clinical development strategies across multiple therapeutic areas and programs. You will shape the scientific strategy for clinical development plans, design trial documents, and oversee clinical trial science.

Role requires leadership in developing Clinical Development Program, authoring study documents, contributing to publications, and mentoring project teams, with close collaboration across departments.