Director, Global Clinical Program Lead

CSL

About The Position

The Global Clinical Program Leader (GCPL) is a critical role within Clinical Development, accountable for designing and executing the clinical strategy for medicine development in alignment with the Project Strategy Document (PSD) and Target Product Profile (TPP). The GCPL provides strategic leadership to the Clinical Development Team (CDT) in a matrix environment and is responsible for timely development and execution of the Clinical Development Plan (CDP), day-to-day CDT operations, decision-making, stakeholder management, and compliance with CSL Behring processes, GCP, and ICH regulations. The role provides clinical and scientific oversight for assigned programs, maintaining high standards throughout program activities and providing expertise during clinical study development. The GCPL serves as a medical monitor or oversees an assigned medical monitor, and represents Clinical Development on the Project Strategy Team and relevant cross-functional teams. The GCPL authors or contributes to key study documents, clinical sections of regulatory packages, and scientific communications. Depending on business needs, the incumbent may also contribute to business development or serve as a Clinical Study Lead. The position requires an advanced degree in life science or healthcare (MD, PhD, or PharmD), with relevant board certification preferred for MDs. Extensive clinical development industry experience and working knowledge of pharmaceutical and regulatory development processes are essential; 3–5 years of relevant clinical development experience, including study data review or evaluation, is expected.

Requirements

Advanced degree (MD, PhD, or PharmD) in life science or healthcare.
Extensive clinical development industry experience.
Working knowledge of pharmaceutical and regulatory development processes.
Expected 3–5 years of relevant clinical development experience, including study data review or evaluation in a pharmaceutical or clinical study environment.
Demonstrated program leadership capabilities in a matrix environment.
Demonstrated stakeholder management skills, including risk mitigation.
Proficiency in project management terminology and processes for driving clinical development program risk mitigation.
Excellent analytical thinking and scientific or medical writing skills.
Proficiency in clinical data analysis and interpretation.
Strong problem-solving skills and ability to think critically and make informed decisions.
Strong communication and presentation skills.
Ability to build bridges and proactively improve cross-functional collaboration.

Nice To Haves

MD board certification, or non-USA equivalent, in a relevant field.

Responsibilities

Lead and guide the cross-functional Clinical Development Team as the lead scientific expert, ensuring appropriate functional representation in team discussions.
Develop and maintain the Clinical Development Plan in alignment with the Project Strategy Team and Therapeutic Area Leadership Team.
Integrate internal and external expert contributions into the strategy and design of assigned clinical programs.
Maintain stakeholder alignment before key decision-making forums.
Ensure programs follow CSL Behring processes and comply with GCP and ICH regulations.
Drive and document CDT decisions, facilitate issue resolution and escalation, and develop contingency plans.
Oversee clinical content for CDT deliverables and ensure safe, efficient, timely, and high-quality execution of assigned programs.
Represent Clinical Development on required cross-functional teams, including study execution, safety management, benefit-risk, biomarker, and evidence and access strategy teams.
Develop and execute the Medical Monitoring Plan strategy; serve as medical monitor during clinical trials or oversee assigned medical monitors.
Present results to Safety Monitoring Committee and other internal and external meetings.
Review study data to assess safety, efficacy, and implications for ongoing R&D and development strategy.
Author or contribute to key study documents, including the TPP, PSD, CDP, study concepts and outlines, Investigator Brochures, protocols, informed consent forms, medical monitoring plans, committee charters, and clinical study reports.
Lead preparation of clinical sections of regulatory interaction packages, including briefing books, INDs, NDAs, BLAs, ODDs, responses to information requests, and routine reports.
Contribute to publication strategy and author or contribute to abstracts, presentations, and manuscripts.
Participate in or lead due diligence projects supporting CSL's external innovation efforts as appropriate.
Undertake business development contributor or Clinical Study Lead assignments as appropriate to business needs.