CSL · 2 months ago
Director, Global Clinical Program Leader, Immunoglobulins
Americas, US-PA, King of Prussia, CSL Behring
Full-time
Hybrid
Lead/Staff, Director/Executive
3+ years expCSL Behring is a global biotherapeutics leader committed to developing innovative therapies for patients. The Director of Clinical Program, Immunoglobulins will lead the clinical strategy and execution for the development of medicines, ensuring compliance with regulations and high-quality standards throughout the clinical development process.
BiotechnologyHealth CareHealth DiagnosticsMedical
Responsibilities
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 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, and timely 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 Delivery Teams (DT) including but not limited to the 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
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
Qualification
Required
Advanced degree (MD or PhD) in life science/healthcare expected
Clinical development industry experience with a working knowledge of pharmaceutical and regulatory development processes is essential
3+ years of relevant clinical development experience is expected 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
Preferred
MD - Board Certified (or non-USA equivalent) in relevant field
Company
CSL
CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$111M2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO
Leadership Team
Jeffrey Ball
Chief Sustainability Officer
Joy Linton
Strategic Advisor
Recent News
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