Medical Director, Global Clinical Program Leader - Immunology

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 Responsibilities:

Business Development & Clinical Support for Internal Pre-Clinical Assets

• 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

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
• 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

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 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 scientific/medical writing skills
• Proficient in clinical data analysis and interpretation
• Proven problem-solving skills and the ability to think critically and make informed decisions
• Demonstrated effective communication and presentation skills
• Builds bridges and proactively improves cross-functional collaboration

The minimum and maximum base salary range that CSL expects to pay for this position at the Waltham, MA USA work location at the time of this posting is $300,000 - $376,000/yr. …