Associate Director TMF Management & Inspection Readiness
Acadia Pharmaceuticals
4 months ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Associate Director, Trial Master File (TMF) Oversight & Inspection Readiness (IR)
Position Summary
Lead operational oversight of the Trial Master File (TMF) and help ensure TMF integrity, sustained inspection readiness, and regulatory compliance within Clinical Operations. Serve as Clinical Operations lead for inspection defense by advancing consistent standards, proactive risk visibility, and clear insight into TMF integrity and inspection readiness.
Primary Responsibilities
- Establish TMF health oversight framework across studies to ensure compliance with GCP and industry standards.
- Monitor TMF quality metrics (completeness, timeliness, accuracy); escalate metrics outside KPIs for resolution and corrective action.
- Lead and share TMF best practices; oversee TMF risk trending and remediation plans.
- Maintain inspection-readiness documentation standards.
- Develop and maintain inspection readiness model, tools, reference materials, and staff training guidance for health authority inspections.
- Lead inspection storyboarding/narrative development; coordinate inspection preparation and lead designated Clinical Operations activities during regulatory inspections.
- Support post-inspection CAPA alignment with Quality.
- Support inspection commitments and responses; implement corrective/preventive actions, provide lessons learned, and ensure portfolio-level visibility of inspection risk.
- Partner cross-functionally to align audit/inspection strategy and TMF platform integrity; align with study teams on TMF accountability.
Qualifications
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- At least 8 years in pharmaceutical industry and/or clinical research organization experience, including at least 5 years of TMF experience in a leadership role.
- Health Authority inspection and eTMF experience required. Equivalent education/experience may be considered.
Key Skills (Required/Preferred)
- Thorough understanding of GCP and ICH guidelines; drug development process.
- Knowledge of global regulatory requirements (e.g., FDA, EMA, MHRA).
- Thorough understanding of the CDISC TMF Reference model; direct experience with the TMF Reference Model working group preferred.
- Veeva Vault eTMF/CTMS experience preferred.
- Strong leadership to lead/motivate/influence stakeholders (preferred).
- Analytical, planning/negotiation, technical/admin and project management skills.
- Strong interpersonal, organizational, workload planning, and verbal/written communication skills.
- Cross-functional collaboration; ability to manage multiple assignments; strong problem-solving and attention to detail.
- Able and willing to travel domestically and internationally.
Benefits (as listed)
- Discretionary bonus and equity awards (eligible; amounts vary).
- Medical, dental, and vision insurance; employer-paid life, disability, business travel and EAP coverage.
- 401(k) with fully vested company match 1:1 up to 5%.
- Employee Stock Purchase Plan with a 2-year purchase price lock-in.
- 15+ vacation days; 13–15 paid holidays (including office closure between Dec 24 and Jan 1).
- 10 days paid sick time; paid parental leave; tuition assistance.
Application/Location Notes
Hybrid role (average 3 office days/week) based in San Diego, CA OR San Francisco, CA OR Princeton, NJ.
Physical/Work Requirements
- Regular work in standard office environment; occasional lifting/moving up to 20 pounds.
- Ability to travel independently overnight and work after hours if required by travel schedule or business needs.
Position Summary
Lead operational oversight of the Trial Master File (TMF) and help ensure TMF integrity, sustained inspection readiness, and regulatory compliance within Clinical Operations. Serve as Clinical Operations lead for inspection defense by advancing consistent standards, proactive risk visibility, and clear insight into TMF integrity and inspection readiness.
Primary Responsibilities
- Establish TMF health oversight framework across studies to ensure compliance with GCP and industry standards.
- Monitor TMF quality metrics (completeness, timeliness, accuracy); escalate metrics outside KPIs for resolution and corrective action.
- Lead and share TMF best practices; oversee TMF risk trending and remediation plans.
- Maintain inspection-readiness documentation standards.
- Develop and maintain inspection readiness model, tools, reference materials, and staff training guidance for health authority inspections.
- Lead inspection storyboarding/narrative development; coordinate inspection preparation and lead designated Clinical Operations activities during regulatory inspections.
- Support post-inspection CAPA alignment with Quality.
- Support inspection commitments and responses; implement corrective/preventive actions, provide lessons learned, and ensure portfolio-level visibility of inspection risk.
- Partner cross-functionally to align audit/inspection strategy and TMF platform integrity; align with study teams on TMF accountability.
Qualifications
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- At least 8 years in pharmaceutical industry and/or clinical research organization experience, including at least 5 years of TMF experience in a leadership role.
- Health Authority inspection and eTMF experience required. Equivalent education/experience may be considered.
Key Skills (Required/Preferred)
- Thorough understanding of GCP and ICH guidelines; drug development process.
- Knowledge of global regulatory requirements (e.g., FDA, EMA, MHRA).
- Thorough understanding of the CDISC TMF Reference model; direct experience with the TMF Reference Model working group preferred.
- Veeva Vault eTMF/CTMS experience preferred.
- Strong leadership to lead/motivate/influence stakeholders (preferred).
- Analytical, planning/negotiation, technical/admin and project management skills.
- Strong interpersonal, organizational, workload planning, and verbal/written communication skills.
- Cross-functional collaboration; ability to manage multiple assignments; strong problem-solving and attention to detail.
- Able and willing to travel domestically and internationally.
Benefits (as listed)
- Discretionary bonus and equity awards (eligible; amounts vary).
- Medical, dental, and vision insurance; employer-paid life, disability, business travel and EAP coverage.
- 401(k) with fully vested company match 1:1 up to 5%.
- Employee Stock Purchase Plan with a 2-year purchase price lock-in.
- 15+ vacation days; 13–15 paid holidays (including office closure between Dec 24 and Jan 1).
- 10 days paid sick time; paid parental leave; tuition assistance.
Application/Location Notes
Hybrid role (average 3 office days/week) based in San Diego, CA OR San Francisco, CA OR Princeton, NJ.
Physical/Work Requirements
- Regular work in standard office environment; occasional lifting/moving up to 20 pounds.
- Ability to travel independently overnight and work after hours if required by travel schedule or business needs.