Director, Global Clinical Program-Hematology

CSL; United States; Hybrid; USD 150,000 - 200,000; Full time

Job summary

A global biopharmaceutical organization is seeking a Director for Global Clinical Program in Hematology. This hybrid position requires leadership in clinical strategy design and execution, with responsibilities including oversight of Clinical Development plans and managing a cross-functional team. Strong clinical development experience with an advanced degree in life sciences is essential. Competitive compensation and a flexible work environment offered.

Qualifications

• 3+ years of relevant clinical development experience expected.
• Demonstrated program leadership capabilities in a matrix environment.
• Proficient in project management terminology and risk mitigation strategies.

Responsibilities

• Design and execute clinical strategy aligned with project goals.
• Manage day-to-day operations of the Clinical Development Team.
• Ensure compliance with all regulatory standards.

Skills

Clinical development experience

Pharmaceutical knowledge

Project management

Strategic leadership

Education

Advanced degree (MD or PhD) in life science/healthcare

Job description

Director, Global Clinical Program-Hematology

Join to apply for the Director, Global Clinical Program-Hematology role at CSL

Could you be our next Director of Clinical Program, Hematology? The job is in our King of Prussia, PA, Waltham MA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week.

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.

Qualifications

• Advanced degree (MD or PhD) in life science/healthcare expected.
• MD - Board Certified (or non-USA equivalent) in relevant field is preferred.
• 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.
• Proficient in project management terminology and processes to drive clinical development program risk mitigation strategies.

Seniority level

• Director

Employment type

• Full-time

Job function

• Research