Associate Director, Clinical Trial Delivery Unit Lead, HI-Bio

Job Description

HI-Bio, Inc., a Biogen company, is seeking a Clinical Trial Delivery Unit (CTDU) Lead to assist in building and maintaining the CTDU group for HI-Bio. This includes defining, developing and embedding operational expertise across the group to secure excellence in operational strategy and execution through our CRO partners. The successful candidate will manage and develop therapeutic area expertise among a group of high functioning Clinical Trial Leads (CTLs) and embeds consistent, efficient processes amongst the CTLs group. They will collaborate with key stakeholders across clinical operations, R&D and other functions to secure alignment in direction and delivery. 

What You’ll Do:

1. Partners with CTDU Management to define, develop and embed operational expertise to secure excellence in operational strategy and execution through the evolving CRO partnership model:

• • Contributes to the development of clinical operations expertise as needed to support the evolving pipeline.
  • Oversees Clinical Trial Leads (CTLs) in the creation of an effective operational strategy in line with disease unit program strategies and incorporating operational expertise.
  • Partners with CTDU Head, Clinical Development and other functions to establish disease unit related best practices and clinical trial innovation strategies to optimize clinical trial delivery
  • Partners with clinical operations and CTDU leadership in ensuring parity and consistency of practice across the CTDUs

2. Secures operational excellence, consistency, compliance and efficiency through line management of a group of Clinical Trial Leads:

• • Oversees and manages Clinical Trial Leads in the creation of an effective operational strategy in line with program strategies and incorporating therapeutic area expertise.
  • Embodies a culture of continuous improvement by seeking consistency and efficiency in processes.
  • Works closely with the CTDU to ensure consistency in staff talent and performance review, to continue to develop and retain strong talent and expertise within the group.
  • Leverages internal and external seeking ways to continually improve and refine.

3. Influences process and Partnership evolution across clinical operations and development striving for effective, consistent, efficient and compliant processes in line with the partnership and internal roles and responsibilities by:

• • Initiates, leads and shares best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Study Leadership group. Identifies interdependencies and synergies with other trials and programs and seeks to proactively put into place process or forum to enhance excellence in planning and execution across all studies in a phase.
  • Follows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model; provides feedback via appropriate channels for opportunities to improve processes or set best practices (i.e. PON).
  • Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model.
  • Partners with clinical operations to escalate issues, sharing best practices and ensuring the CTLs leverage Vendor Operations Relationship Managers for issue resolution.

Qualifications

Required Skills:

• Bachelor's degree in a scientific discipline
• Approximately 8-10 years of clinical research / project management experience preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline, and budget expectations.
• Deep understanding of the SMT Chair role and clinical development within relevant phase area (Phase I, II, III, IV) and a working understanding of cross functional drug development. Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas. Ability to establish operational plans and support the CRO in the execution of the plans. Requires a balance of scientific and operational/project management and team leadership expertise. Must be able to build effective relationships across and up and down the organization.
• Excellent project management skills, including risk assessment and contingency planning. Must have effective prior CRO management skills.
• Able to partner with other functions and both internal and external stakeholders. Excellent leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
• Ability to line manage high functioning team members, including