Senior Medical Director, Global Clinical Program Lead - Immunoglobulins

CSL Plasma • Waltham, MA

8d • Hybrid

About The Position

The Senior Medical Director, Global Clinical Program Leader (GCPL) is a critical role within Clinical Development, accountable for designing and executing the clinical strategy for a medicine in alignment with the Project Strategy Document (PSD) and Target Product Profile (TPP). The role provides strategic leadership to the Clinical Development Team (CDT) in a matrixed environment and reports to the Global Clinical Lead (GCL).

The position leads scientific and clinical oversight across assigned programs, supports high-quality study execution, develops medical monitoring strategy, and contributes to key clinical, regulatory, and scientific documents and communications. The position is hybrid, based onsite at any of the posted locations, with a minimum of three days onsite weekly. Relocation assistance and visa sponsorship are not provided.

Requirements

• MD, PhD, or PharmD in a life science or healthcare discipline.
• At least 5 years of relevant clinical development experience in the pharmaceutical industry, including study data review and evaluation.
• Clinical development industry experience and working knowledge of pharmaceutical and regulatory development processes.
• Demonstrated program leadership in a matrixed environment.
• Demonstrated stakeholder management skills, including risk mitigation.
• Proficiency in project management terminology and processes to drive clinical development program risk mitigation strategies.
• Excellent analytical thinking and scientific or medical writing skills.
• Proficiency in clinical data analysis and interpretation.
• Effective 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

• Board certification (or non-USA equivalent) in a relevant field for candidates with an MD.

Responsibilities

• Lead and guide members of the cross-functional Clinical Development Team as the program’s lead scientific expert, ensuring appropriate functional representation.
• Lead the timely development and maintenance of the Clinical Development Plan in alignment with the Program 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, including the Strategic Development Committee and Scientific and Technical Review Committee.
• Ensure programs comply with CSL Behring processes, Good Clinical Practice, and ICH regulations.
• Drive and document CDT decision-making; facilitate issue resolution and escalation, and develop contingency plans.
• Oversee clinical content in CDT deliverables and ensure safe, efficient, timely, high-quality program execution and appropriate scientific standards.
• 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 the Medical Monitoring Plan strategy; typically serve as a clinical-trial medical monitor or oversee assigned medical monitors.
• Present results to Safety Monitoring Committees and other internal and external meetings.
• Participate in or lead due diligence projects supporting CSL’s external innovation efforts.
• Review study data to assess safety and efficacy findings and their implications for ongoing R&D strategies, and support definition of development strategy.
• Lead or contribute to authorship of key study and program documents, including the TPP, PSD, CDP, study concepts and outlines, Investigator Brochure, protocols, informed consent forms, medical monitoring plans, committee charters, and clinical study reports.
• Lead preparation of clinical sections of regulatory interaction packages and routine reporting, including briefing books, INDs, NDAs, BLAs, ODDs, and RFIs.
• Contribute to publication strategy and author or contribute to abstracts, presentations, and manuscripts as appropriate.

Benefits

• Incentive compensation and equity may be included in total compensation in addition to base salary.
• CSL provides employee benefits; further details are available through the company’s benefits information.

What This Job Offers

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