Medical Director, Global Clinical Program Leader - Immunology

*** 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.

• Serve as a clinical representative on one or more due diligence teams evaluating external assets creating timely CDPs, slide decks, clinical input, expert KOL feedback and presentations to management
• Working with commercial, develop high-level target product profiles for pre-clinical internal assets
• Develop CDPs for these pre-clinical internal assets and present at developmental Stage Gate meetings

• 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
• Is 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)
• Responsible for 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

• 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

• 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

• MD, PhD or PharmD) in life science/healthcare required
• MD - Board Certified (or non-USA equivalent) in relevant field preferred
• Extensive clinical development pharmaceutical/biotechnology industry experience with a working knowledge of pharmaceutical and regulatory development processes is essential
• 3+ years of relevant clinical development experience including experience of study data review/evaluation in a pharmaceutical or clinical study environment
• Demonstrated program leadership capabilities in a matrix environment
• Demonstrated stakeholder management skills including risk mitigation
• Proficient in project management terminology and processes to drive clinical development program risk mitigation strategies
• Proven analytical thinking and…