Senior Medical Director, Global Clinical Program Lead - Immunoglobulins

Position Overview:

The Senior Medical Director, Global Clinical Program Leader (GCPL) is a critical role within Clinical Development. The Senior GCPL is

accountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP). The GCPL is accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrixed environment. Reports to the Global Clinical Lead (GCL).

Work Environment:

*** This is a hybrid position based onsite at any of the posted locations with a minimum of 3 days onsite weekly. Relocation assistance and visa sponsorship are not provided.

Key Resonsibilities:

Clinical Development Team (CDT) Leadership:

• Provides leadership and guidance to all members of the cross-functional CDT acting as the lead scientific expert for the clinical program, while ensuring appropriate functional representation in team discussions
• accountable for the timely development and maintenance of the Clinical Development Plan (CDP) in alignment with the Program Strategy Team (PST) and Therapeutic Area Leadership Team (TALT)
• Leads the integration of internal and external expert contributions to strategy and design of the assigned clinical program(s)
• Maintaining alignment across critical stakeholders prior to key decision making forums (e.g. Strategic Development Committee (SDC) or Scientific and Technical Review Committee (STRC) for study outline approval)
• Ensures that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations
• Responsible for driving and documenting decision making within the CDT, facilitating issue resolution and escalation, as well as contingency planning

Clinical & Scientific Oversight:

• Accountable for the clinical content for all CDT deliverables to ensure safe, efficient, timely and quality execution of assigned clinical programs
• Ensures high quality clinical and scientific standards are met throughout all aspects of the program
• Serves as the clinical development representative on the required cross-functional teams, including but not limited to the Study Execution Team (SET), Safety Management Team (SMT), the Benefit-Risk Assessment Team (BRAT), the Biomarker Expert Team (BET), and the Evidence and Access Strategy Team (EAST) for assigned programs
• Develops and executes the Medical Monitoring Plan (MMP) strategy
• Typically serves as the medical monitor for clinical trials during study conduct or provides oversight to assigned medical monitors
• Presents results to Safety Monitoring Committee and other internal and external meetings
• May participate or lead Due Diligence projects in support of CSL’s external innovation efforts

Document Authorship:

• Reviews the data generated during the planning and execution of a study to gather a clinical understanding of the safety and efficacy results and the impact of the data on ongoing R&D strategies and provides support in defining the development strategy
• “Lead Author” or “Contributing” Author for key study documents, including but not limited to: the TPP, PSD, CDP, Study Concept Scenarios, Study Outlines, the Investigator Brochure (IB), Clinical Study Protocols (CSP), Master Informed Consent Forms (ICF), Medical Monitoring Plans (MMP), Safety Review Committee (SRC)/Independent Data Monitoring Committee (IDMC) Charters, and Clinical Study Reports (CSR)
• Leads preparations of clinical sections of relevant regulatory interaction packages including but not limited to briefing books, INDs, NDAs. BLAs, ODDs, RFIs, and routine reporting
• Contributing author the publication strategy. Author or contributing author for abstracts, presentations, and manuscripts as appropriate

Minimum Qualifications:

• MD, PhD or PharmD in life science/healthcare discipline expected. MD - Board Certified (or non-USA equivalent) in relevant field is preferred.
• 5+ years of relevant clinical development experience in the pharmaceutical industry is expected including experience with study data review/evaluation
• Clinical development industry experience with a working knowledge of pharmaceutical and regulatory development processes is essential
  Demonstrated program leadership capabilities in a matrixed environment
• Demonstrated stakeholder management skills including risk mitigation
• Proficient in project management terminology and processes to drive clinical development program risk mitigation strategies
• Excellent analytical thinking and scientific/medical writing skills
• Proficient in clinical data analysis and interpretation
• Proven effective problem-solving skills and the ability to think critically and make informed decisions
• Demonstrated effective communication and presentation skills
• Proven ablility to build bridges and proactively improve cross-functional collaboration

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