Senior Director, Clinical Strategy and Delivery

Premier Research; España; Presencial; EUR 120.000 - 180.000; Jornada completa

Descripción de la vacante

Premier Research is seeking a Senior Director, Clinical Strategy and Delivery to lead the Clinical Management team. You will help translate breakthrough science into medicines, devices, and diagnostics while driving RBM strategy and risk management.

With 12+ years in clinical research and 5+ years in leadership, you will guide start-up to close-out activities, oversee monitoring approaches, and collaborate with internal and external partners to deliver high-quality results.

Formación

• Bachelor’s degree in a related field or equivalent.
• 12+ years of clinical research experience with 5+ years in Clinical Trial Manager/Clinical Lead or Project Management.
• Expert knowledge of GCP and ICH E6 R2 guidelines and regulatory requirements.
• Experience implementing Risk Based Monitoring methodologies.
• Strong understanding of all aspects of clinical operations from start-up to close-out.
• Expertise with central monitoring approaches and systems.

Responsabilidades

• Participates in Proposal Development for Clinical Operations, shaping RBM strategy.
• Supports commercial activities such as Bid Defense meetings, representing clinical operations and RBM components.
• Collaborates with SSU staff to keep start-up activities on schedule and escalates delays.
• Creates and oversees monitoring strategy for internal teams and sponsors with justification for chosen approach.
• Maintains knowledge of industry trends and regulatory framework.
• Evaluates RACT for quality and ICH compliance, and participates in risk assessment meetings.
• Oversees management of protocol execution risks and closes loop on issue resolution.
• Coordinates with internal and external vendors to operationalize the monitoring strategy.

Conocimientos

GCP & ICH E6 R2

Risk Based Monitoring

Clinical operations delivery

Project management

Budget/financial management

Line management

Educación

Bachelor’s degree in related field

Herramientas

Central monitoring tools

Regulatory systems

Descripción del empleo

Premier Research is looking for a Senior Director, Clinical Strategy and Delivery to join our Clinical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• Your ideas influence the way we work, and your voice matters here.
• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You’ll Be Doing

• Participates in Proposal Development on behalf of Clinical Operations, ensuring an RBM strategy provided where appropriate.
• Supports commercial activities such as Bid Defense meetings, representing clinical operations and Risk Based monitoring components.
• Collaborates with SSU staff to ensure start-up activities remain within expected timelines and escalates any delays as appropriate.
• Create and oversees the monitoring strategy for internal teams and sponsors. Provides justification and rationale for selected monitoring strategy and process.
• Maintains expert knowledge and understanding of industry trends and the associated regulatory framework.
• Evaluates the Risk Assessment and Categorization Tool (RACT) for quality, consistency, and ICH compliance. Participates in the initial Risk Assessment and in the on-going Risk Review meetings for assigned projects.
• Oversees clinical teams’ management of protocol execution risks related to clinical delivery, ensuring a “closed loop” on issue resolution.
• Works with the internal and external technology vendors to ensure operationalization of the monitoring strategy is feasible and supports Central Monitoring activities.

What We Are Looking For

• Bachelor’s degree in a related field, or equivalent combination of education, training and prior work experience.
• Minimum of twelve (12) years clinical research experience with at least five (5) years of Clinical Trial Manager, Clinical Lead or Project Management experience. f Line management experience preferred
• Expert knowledge of GCP and ICH E6 R2 guidelines and other applicable regulatory requirements.
• Experience in implementation of Risk Based Monitoring methodologies and concepts.
• Must demonstrate good understanding of all aspects of clinical operations delivery, from start-up to maintenance and close-out.
• Expertise with central monitoring approaches and systems and tools.
• Strong understanding and experience with financial management of projects.