Senior Medical Director, Global Clinical Program Lead - Immunoglobulins
About The Position
The Senior Medical Director, Global Clinical Program Leader (GCPL) is a critical role within Clinical Development, accountable for designing and executing clinical strategy for a medicine in alignment with the Project Strategy Document (PSD) and Target Product Profile (TPP). The role provides strategic leadership to a matrixed Clinical Development Team (CDT) and reports to the Global Clinical Lead (GCL). The GCPL leads cross-functional program planning and execution, maintains alignment with relevant internal and external stakeholders, and ensures program conduct follows CSL Behring processes and applicable GCP and ICH regulations. The role oversees clinical and scientific content and quality, medical monitoring strategy, study data review, regulatory interaction materials, and clinical development documentation. The position may also support due diligence for external innovation efforts. This is a hybrid position based onsite at any of the posted locations, with a minimum of three onsite days per week. 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 capabilities 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/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
- Lead and guide cross-functional CDT members as the lead scientific expert for the clinical program, ensuring appropriate functional representation in team discussions.
- Develop and maintain the Clinical Development Plan (CDP) in a timely manner and align it with the Program Strategy Team (PST) and Therapeutic Area Leadership Team (TALT).
- 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 (SDC) and Scientific and Technical Review Committee (STRC).
- Ensure programs comply with CSL Behring processes, GCP, and ICH regulations.
- Drive and document CDT decisions, facilitate issue resolution and escalation, and plan contingencies.
- Oversee clinical content for CDT deliverables to support safe, efficient, timely, and high-quality execution of assigned programs.
- Ensure high clinical and scientific standards throughout the program.
- Represent clinical development on cross-functional teams, including the Study Execution Team (SET), Safety Management Team (SMT), Benefit-Risk Assessment Team (BRAT), Biomarker Expert Team (BET), and Evidence and Access Strategy Team (EAST).
- Develop and execute the Medical Monitoring Plan (MMP) strategy.
- Typically serve as medical monitor during clinical trials 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, as applicable.
- Review study data generated during planning and execution to assess safety, efficacy, and implications for ongoing R&D strategies and development plans.
- Lead or contribute to key study documents, including the TPP, PSD, CDP, Study Concept Scenarios, Study Outlines, Investigator Brochure (IB), Clinical Study Protocols (CSP), Master Informed Consent Forms (ICF), MMPs, SRC/IDMC Charters, and Clinical Study Reports (CSR).
- Lead preparation of clinical sections of regulatory interaction packages, including briefing books, INDs, NDAs, BLAs, ODDs, RFIs, and routine reports.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
