The Associate Director, Clinical Operations provides clinical operational strategy and oversight of multiple indications, and programs to ensure clinical programs are conducted to meet project milestones, with close attention to budget and quality in close partnership with internal and external stakeholders. The Associate Director will provide oversight and direction within the Clinical Operations department while mentoring and developing junior department members and project team partners.
Specific Responsibilities and Skills for Position (included but not limited to):
- Provide leadership and oversight for the successful management of international clinical trials (Phase I - IV) across multiple indications through clinical study teams and through the use of CROs or internal resources.
- Provide strategic direction in development and implementation of process changes
- Lead and partner in the development and presentation of clinical operational strategy to senior/executive leadership.
- Responsible for financial oversight, managing spend as planned and ensuring appropriate communication with finance and leadership.
- Leads the development, review and implementation of departmental SOPs and processes. Participates in development and implementation of cross-departmental SOPs and processes.
- Contribute to Clinical Study Reports, INDs, NDAs and other clinical/regulatory/safety documents.
- Function as sponsor for preferred vendor relationships.
- Serve as a primary point of contact for Clinical Operations in cross-functional processes and disseminate information appropriately across the department.
- Collaborate with regulatory, medical affairs and commercial to assist with life cycle management of approved drug products.
- Initiate and oversee continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams.
- Manages a team of people, including other managers. Provides mentoring and coaching of direct reports regularly and provides leadership to the entire team.
Required & Preferred Experience and Knowledge:
- The ability to solve complex problems and use highly developed independent judgement relating to national and international regulations, guidelines, investigator interactions, and timelines.
- A demonstrated excellence in complex project management and the effective management of multiple projects/priorities
- The ability to initiate and lead departmental or interdepartmental strategic initiatives
- The proven ability to think critically and creatively, and to be able to work independently to determine appropriate resources for resolution of complex problems
- The ability to effectively use interpersonal skills to manage people managers and mentor and develop junior staff
- A demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials
- The ability to influence across a matrix and create a clear sense of direction
- Prior experience in the oversight and management of regulatory inspections (eg, FDA, EMA, MHRA) in collaboration with Regulatory Compliance is preferred.
- This position may require national or international travel as required (valid travel documents must be obtainable).
Education and Experience Requirements:
- At a minimum, a bachelor’s degree in nursing, science or health related field
- At least 9 years of related clinical trial management experience
- Knowledge of oncology, transplant patient care, and apheresis collection a plus.