Medical Director, Global Clinical Program Leader - Immunology

CSL Plasma • Waltham, PA

9d • Hybrid

About The Position

The Medical Director, Global Clinical Program Leader for Immunology leads clinical development programs and serves as the lead scientific and clinical expert for cross-functional Clinical Development Teams (CDTs). The role develops and maintains Clinical Development Plans in alignment with program strategy and therapeutic-area leadership, integrates internal and external expert input, coordinates stakeholder alignment for key decisions, and ensures work follows CSL Behring processes, Good Clinical Practice, and ICH regulations.

The position provides clinical and scientific oversight for program deliverables and execution, including medical-monitoring strategy, study safety and efficacy review, and support for regulatory interactions and clinical documents. It also contributes to business development and external innovation by evaluating external assets and developing plans for internal pre-clinical assets. The role is hybrid, based onsite at one of the posted locations at least three days per week. Relocation assistance and visa sponsorship are not provided.

Requirements

• MD, PhD, or PharmD in life science or healthcare required.
• Extensive clinical development experience in the pharmaceutical or biotechnology industry and working knowledge of pharmaceutical and regulatory development processes.
• At least 3 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 to drive clinical development program risk mitigation strategies.
• Proven analytical thinking and scientific or medical writing skills.
• Proficiency in clinical data analysis and interpretation.
• Proven problem-solving skills and ability to think critically and make informed decisions.
• Effective 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

• Serve as a clinical representative on due diligence teams evaluating external assets, preparing clinical development plans, slide decks, expert feedback, and management presentations.
• Work with commercial teams to develop target product profiles and clinical development plans for internal pre-clinical assets, and present them at developmental Stage Gate meetings.
• Lead and guide cross-functional Clinical Development Teams as the lead scientific expert for clinical programs.
• Develop and maintain Clinical Development Plans in alignment with the Program Strategy Team and Therapeutic Area Leadership Team.
• Integrate internal and external expert contributions into clinical program strategy and design.
• Maintain stakeholder alignment before key decision-making forums, including the Strategic Development Committee and Scientific and Technical Review Committee.
• 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.
• Provide clinical content for CDT deliverables and ensure safe, efficient, timely, high-quality execution of assigned clinical programs.
• Maintain high clinical and scientific standards throughout program activities.
• Represent clinical development on cross-functional teams, including Study Execution, Safety Management, Benefit-Risk Assessment, Biomarker Expert, and Evidence and Access Strategy teams.
• Develop and execute Medical Monitoring Plan strategy; serve as medical monitor for trials or oversee assigned medical monitors.
• Present results to Safety Monitoring Committees and other internal and external meetings.
• Review study data to assess safety and efficacy and their implications for ongoing R&D strategy.
• Lead or contribute to authorship of key documents, including target product profiles, program and study plans, investigator brochures, protocols, informed consent forms, medical monitoring plans, committee charters, and clinical study reports.
• Lead preparation of clinical sections of regulatory interaction packages and routine reports, including briefing books, INDs, NDAs, BLAs, ODDs, and responses to information requests.
• 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.

Benefits

• Incentive compensation and equity may be included in total compensation, in addition to base salary.
• CSL benefits are referenced, but specific benefits are not listed in the posting.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree