Post-Trial Access Manager, Continued Access is accountable for the execution of multiple global PTA programs, of mild and moderate complexity, with minimal supervision.
PTA here refers to the provision of investigational product for the intent of treatment, in a non-trial setting and under the care of a physician, following participation in a trial. PTA by this definition is governed by local laws and regulations and may be provided by established regulatory mechanisms such as early access, named patient programs, and other pre-approval access and managed access programs.
Summary of the Essential Functions of the Job
- Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
- Ensure compliance with regulatory requirements and company Policies/SOPs
- Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs
- Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation
- Drive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts)
- Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders; with support as needed
- Ensure alignment across PTA program decisions, documentation, plans, and implementation
- Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products
- Manage requests for investigational product access through PTA programs, ensuring timely and compliant processing
- Manage vendor contracting and deliverables in support of PTA/continued access program execution
- Utilize PTA tools, templates, and systems to ensure accurate tracking and reporting of investigational access programs
- Monitor quality, KPIs, and program performance; identify issues and escalate as needed
- Communicate PTA program status, risks, and updates to stakeholders
- Identify risks and implement mitigation strategies specific to investigational product access and program continuity; capture lessons learned and best practices
- Ensure inspection readiness, maintain complete and accurate documentation, and perform quality checks for PTA programs
- Support other PTA/continued access activities and programs, as assigned
Minimum Requirements
- BS/BA (or equivalent experience)
- Experience in clinical research or biopharmaceutical operations; including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval; comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered
- General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research
- Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision
- Proven experience collaborating effectively; influencing stakeholders across functions and levels
- Evidence of strong project management skills; including managing competing priorities and solving operational challenges in clinical or investigational program environments
- Successful history of working independently in a global environment
- Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage, though it is not a mandatory requirement.
Additional Attributes Required:
- Ability and enthusiasm to thrive in a dynamic and evolving clinical development and investigational product access environment
- Demonstrates a proactive, detail-oriented, critical-thinking, problem-solving, and collaborative approach
- Interest and continual advancement toward subject matter expertise in PTA space
- Experience and interest in the Essential Functions listed, particularly those related to continued access for patients receiving investigational therapies
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.