Associate Director TMF Management & Inspection Readiness

Acadia Pharmaceuticals•Princeton, NJ

5d•Hybrid

About The Position

The Associate Director, Trial Master File (TMF) Oversight & Inspection Readiness (IR) is responsible for leading the operational oversight of the TMF and supporting the framework that ensures Trial Master File integrity, sustained inspection readiness, and regulatory compliance within Clinical Operations. This role leads TMF health governance, inspection preparedness, and risk identification processes to safeguard the organization during regulatory inspections and audits. The Associate Director serves as the Clinical Operations lead for inspection defense, by advancing consistent standards, proactive risk visibility, and clear organizational insight into TMF integrity and inspection readiness.

Requirements

Bachelor’s degree in life sciences or related field; Advanced degree preferred.
Targeting at least 8 years pharmaceutical industry and/or clinical research organization experience, with at least 5 years TMF experience in a leadership role.
Health Authority inspection and eTMF experience is required.
An equivalent combination of relevant education and experience may be considered.
Thorough understanding of GCP and ICH guidelines; thorough understanding of the drug development process.
Knowledge and understanding of the current regulatory requirements (e.g., FDA, EMA, MHRA) in a global environment.
Thorough understanding of the CDISC TMF Reference model; direct experience with the TMF Reference Model working group is preferred.
Veeva Vault eTMF/CTMS experience preferred.
Ability to lead, motivate, and influence others, including prior leadership experience, is strongly preferred.
Adept at creating and communicating a clear vision among, effectively aligning resources and motivating stakeholders to achieve goals.
Demonstrated analytical abilities and proficient planning and negotiation skills.
Demonstrated technical, administrative and project management capabilities.
Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output.
Demonstrated problem-solving abilities, with strong attention to detail.
Able and willing to travel both domestically and internationally.

Responsibilities

Establish TMF health oversight framework across studies, ensuring compliance with GCP and industry standards.
Monitor TMF quality metrics across programs, ensuring completeness, timeliness, and accuracy of essential documents; Escalate any TMF metrics falling outside of KPIs to appropriate stakeholders for resolution and corrective action.
Lead and share TMF best practices with internal and external stakeholders, as appropriate.
Oversee TMF risk trending and remediation plans.
Maintain inspection-readiness standards for documentation.
Develop and maintain a sustainable inspection readiness model, including development and maintenance of comprehensive inspection readiness tools, reference materials and coordinating training guidance to staff on preparation efforts for health authority inspections.
Lead inspection storyboarding and narrative development.
Coordinate inspection preparation activities.
Lead designated Clinical Operations activities during regulatory inspections.
Support post-inspection CAPA alignment, in partnership with Quality.
Support Clinical Operations team on all inspection commitments, responses, post-inspection activities and implementation of corrective and preventative actions; provide lessons learned from mock and actual inspections.
Ensure portfolio-level visibility of inspection risk.
Partner cross-functionally to align on audit and inspection strategy, as well as TMF platform integrity.
Align with functional study teams on TMF accountability expectations.
Maintain awareness of industry trends and developments to help define the future strategic direction for TMF and Inspection Readiness.
Other responsibilities as required.