Director, Global Clinical Program Lead

CSL; Maidenhead; On-site; GBP 140,000 - 180,000; Full time

Job summary

CSL Behring is seeking a Global Clinical Program Leader (GCPL) for the design and execution of the clinical strategy in a matrixed Clinical Development Team. The role ensures alignment with GCP/ICH and CSL Behring processes, with responsibility for the Clinical Development Plan and cross-functional collaboration.

The GCPL provides medical oversight, acts as lead author for key study documents, and leads scientific discussions with internal and external stakeholders.

Qualifications

• Advanced degree in life sciences (MD/PhD/PharmD).
• 3–5 years of clinical development experience.
• Demonstrated program leadership in a matrix environment.
• Excellent scientific writing and communication skills.

Responsibilities

• Provides leadership as lead scientific expert for the clinical program.
• Ensures timely development and maintenance of the Clinical Development Plan (CDP).
• Leads integration of internal and external expert contributions to strategy and design.
• Serves as clinical development representative on cross-functional teams.
• Prepares clinical sections of regulatory interaction packages and publications.

Skills

Clinical development

Leadership

Medical writing

Analytical thinking

Communication skills

Education

MD/PhD/PharmD

Job description

The Global Clinical Program Leader (GCPL) is a critical role within Clinical Development. The GCPL is 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 Project Strategy Team (PST)
• serves as the Clinical Development representative, or provides oversight to an assigned representative to cross-functional delivery teams (eg, Study Execution Team, etc.)
• undefinedThis 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. The incumbent may also be assigned as a Business Development (BD) Contributor, or a Clinical Study Lead as appropriate for projects as assigned per business need.

Main Responsibilities and Accountabilities:

• 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.

2. 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.

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.

Position Qualifications and Experience Requirements:

Education

Advanced degree (MD, PhD or PharmD) in life science/healthcare expected.

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

Experience

• Extensive clinical development industry experience with a working knowledge of pharmaceutical and regulatory development processes is essential.
• 3-5 years of relevant clinical development experience is expected including experience of study data review/evaluation in a pharmaceutical or clinical study environment.
• undefined
• Demonstrated program leadership capabilities in a matrix environment
• Proficient in project management terminology and processes to drive clinical development program risk mitigation strategies
• Excellent analytical thinking and scientific/medical writing skills
• Proficient in clinical data analysis and interpretation
• Strong problem-solving skills and the ability to think critically and make informed decisions
• Strong communication and presentation skills
• Builds bridges and proactively improves cross-functional collaboration

The role can be based in Glattbrugg, Switzerland/ King of Prussia, USA / Waltham, USA/Maidenhead, UK and requires an onsite presence of 3 days per week.