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Associate Director, TMF Management & Inspection Readiness
Job Description
This role will be a highly qualified and motivated individual who will own the TMF Management and Inspection Readiness group. The role will provide TMF SME expertise across all therapeutic areas and research phases and will be required to work closely with R&D teams and Contract Service Providers (CSPs) as clinical trials are crafted and conducted.
Primary Responsibilities- Is responsible for resource planning, including consultants, to support TMF and inspection readiness including TMF management vendor to ensure compliance with GCP and industry standards.
- Provide leadership and oversight for the Trial Master File (TMF) process, including the TMF related controlled documents/templates, ensuring compliance with regulatory requirements and organizational standards.
- Review TMF metrics across programs, analyzing TMF 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 provide 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.
- Other responsibilities as required.
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. 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.
- 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.
Physical Requirements
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.
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In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
What we offer you (US-Based Employees):
- 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
EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply - especially if the reason you are the best candidate isn't exactly as we describe it here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia's career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
Notice for California Applicants: Please see our California Applicant Privacy Notice within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. ("Acadia"). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity
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