Senior Director Global Clinical Program Lead Cardiovascular & Renal

You will be 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). You are also accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrix environment and is responsible for:

• the timely development and execution of the Clinical Development Plan (CDP).

• managing the day-to-day operations of the CDT including but not limited to meeting coordination and documentation, decision making, and stakeholder management.

• ensuring that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations.

This position is accountable for the clinical & scientific oversight of the assigned program(s) and:

• ensures high quality clinical & scientific standards are met during all aspects of the program

• providing clinical oversight and expertise during development of clinical studies

• serves as medical monitor for assigned clinical trials or provides oversight to an assigned medical monitor

• serves as the Clinical Development representative on the required cross-functional Delivery Teams (DT)

This position is a “Lead Author” or “Contributing Author” for:

• key study documents, including but not limited to the Clinical Development Plan (CDP), the Project Strategy Document (PSD), Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent Forms (ICF), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR).

• the clinical sections of relevant regulatory packages (e.g. IND, NDA, annual reports) and support regulatory RFIs as needed.

• the development of abstracts, presentations, and manuscripts as appropriate.

Main Responsibilities:

1 Clinical Development Team (CDT) Leadership:

• 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.

2 Clinical & Scientific Oversight:

• 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.

3 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.

• 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. 

Qualifications and Experience Requirements:

• MD - Board Certified (or non-USA equivalent) in relevant field is preferred (Nephrology).

• Clinical development industry experience with a working knowledge of pharmaceutical and regulatory development processes is essential.

• 5+ years of relevant clinical development experience is expected including experience of study data review/evaluation in a pharmaceutical or clinical study environment