Director, Global Clinical Program Lead

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:

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 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

Competencies

• 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
• 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

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .