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CSL · 1 month ago

Director, Global Clinical Program Leader, Immunoglobulins

King of Prussia, PA

Full-time

Hybrid

Lead/Staff, Director/Executive

3+ years exp

CSL is a global biotherapeutics leader committed to developing therapies that make a meaningful difference worldwide. The Director of Clinical Program, Immunoglobulins will lead the Clinical Development Team and be responsible for the design and execution of the clinical strategy, ensuring high-quality clinical standards and oversight of assigned programs.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Responsibilities

You will be a critical role within Clinical Development

You are 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 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

1 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 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

“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

Advanced degree MDAdvanced degree PhDClinical development experienceRegulatory development processesProgram leadership capabilitiesStakeholder management skillsProject management proficiencyMedical monitoring expertiseScientific oversightClinical study documentation

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