Associate Director, TMF Management
2 days ago
We are a leading biopharmaceutical company dedicated to developing innovative treatments for central nervous system disorders. With a strong commitment to advancing breakthroughs in neuroscience, we strive to elevate life for those affected by these conditions.
Our team is passionate about delivering high-quality solutions that make a meaningful difference in the lives of our patients. We are seeking a highly skilled and motivated individual to join our team as an Associate Director, TMF Management.
Job SummaryThe Associate Director, TMF Management will be responsible for leading the Trial Master File (TMF) Management and Inspection Readiness group. This role will provide expertise in TMF management across all therapeutic areas and research phases, working closely with R&D teams and Contract Service Providers (CSPs) to ensure compliance with GCP and industry standards.
Key Responsibilities- Oversee resource planning, including consultants, to support TMF and inspection readiness, ensuring compliance with GCP and industry standards.
- Provide leadership and oversight for the TMF process, including controlled documents/templates, ensuring compliance with regulatory requirements and organizational standards.
- Review TMF metrics across programs, analyzing performance indicators and identifying trends or deviations from Key Performance Indicators (KPIs).
- Escalate any TMF metrics falling outside of KPIs to appropriate stakeholders for resolution and corrective action.
- Serve as a key point of contact for TMF-related inquiries and provide SME guidance to internal stakeholders on TMF processes and requirements.
- Lead the development and maintenance of comprehensive inspection readiness plans, tools, reference materials, and training, coordinating activities and providing guidance to staff on preparation efforts for health authority inspections.
- 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.
- Assist the liaison between Acadia and regulatory agencies, facilitating communication and information exchange during inspections and providing leadership to staff in inspection preparation and response strategies.
- Lead and share TMF best practices with internal and external stakeholders, as appropriate.
- Maintain awareness of industry trends and developments to help define the future strategic direction for TMF and Inspection Readiness.
- Bachelor's degree in the life sciences or related field; advanced degree preferred.
- Targeting at least 8 years pharmaceutical industry and/or clinical research organization experience, with at least 4 years TMF experience in a leadership and oversight role.
- Health Authority inspection experience is required.
- 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.
- eTMF experience required; Veeva Vault eTMF/CTMS experience preferred.
- Demonstrated problem-solving abilities, with strong attention to detail.
- Adept at creating and communicating a clear vision among direct reports, effectively aligning resources and motivating stakeholders to achieve goals.
- Demonstrated analytical abilities and proficient planning and negotiation skills.
- 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 technical, administrative, and project management capabilities.
- Ability to travel approximately 25% of the time.
- Competitive base, bonus, new hire, and ongoing equity packages.
- Medical, dental, and vision insurance.
- 401(k) Plan with a fully vested company match 1:1 up to 5%.
- Employee Stock Purchase Plan with a 2-year purchase price lock-in.
- 15+ vacation days.
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st.
- 10 days of paid sick time.
- Paid parental leave.
- Tuition assistance.
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