Associate Director – Clinical Trial Manager
We are a gene therapy company changing lives with every genetic advancement.
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that cure genetic diseases has never wavered.
As the only end-to-end gene therapy company in the industry, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our global headquarters are in Research Triangle Park, North Carolina, a thriving biotechnology hub, and we maintain additional research and development operations in Scotland and France and gene therapy manufacturing in Spain.
We have an opportunity for an Associate Director – Clinical Trial Manager to join the AskBio team in our Durham, North Carolina location and to be part of our continued success! Position offered will be determined by candidate background, skills, qualifications and level of experience.
About the Role
The Associate Director – Clinical Trial Manager position will provide management and oversight of AskBio’s pipeline studies. The incumbent will be responsible for aspects of study conduct and CRO oversight and will be a key point of contact for clinical study project management, communications, and daily operations for the clinical INDs held by AskBio. Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements are essential.
Responsibilities and Accountabilities
- Ability to manage and collaborate on complex protocols within a matrix environment (Data Management, Safety, budget oversight, outsourcing and vendor alliance management).
- Critical thinking skills for problem solving with strategic thinking capacity to drive the study(ies) and to understand the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines
- Identifies opportunities for increased efficiency and consistency and provides leadership and support to improvement initiatives
- Delivers expertise to Clinical Operations teams to drive standardization and formulating solutions to complex issues
- Works with project/program head(s) to define and develop clinical trial objectives and milestones; manages and reports comprehensive study timelines and metrics; management/oversight of external vendor deliverable reports and budgets
- Reports on all aspects of the study progress to Operations management and as necessary to other and more senior levels across the business
- Effective, consistent & regular tracking of project(s)
- Core member of Project Teams and works with project manager to develop trial plans and budgets; collaborates within Clinical Operations and with other departments on study budget management and vendor and site payments; oversees delivery of clinical studies to agreed milestones and budgets
- Collaborates with the following groups across the trial program such as: Data Management, Statistics, Clinical Supplies, Safety, etc. to identify and mitigate risks to study integrity and delivery to timelines, budget, quality
- Participates in all CRO study related calls and meeting, tracks actions, escalates & resolves issues and oversees all aspects of daily study operations to ensure appropriate sponsor oversight.
- Ability to identify issues and risks, develop and manage mitigation and/or escalate risks appropriately
- Utilizes project management skills to ensure consistency in processes and drives Clinical Operations performance
- Daily interactions with the study CRO project manager and other AskBio Clinical Trial Staff
- Collaborates in the preparation and/or review of study-related documents (e.g., Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals)
- Ensures audit-ready condition of clinical trial documentation including central clinical files (TMF)
- Collaborates in the writing and review of study protocols, informed consents and amendments
- Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs
- Ensures Trial Master Files (TMFs) are properly maintained
- Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities
- Adaptable / flexible, self-starter (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
- Excellent team player; willingness and ability to fill functional gaps in a small organization
- Bachelor’s Degree is required, preferably in scientific or health care discipline
- Minimum of 5 years of pharmaceutical, biotech or CRO related/ clinical research experience (oncology or rare disease experience may be beneficial but not required); Associate and Director level require minimum 8 or 10 years respectively
- CRO oversight experience required, including feasibility assessments of clinical trials with focus on competitive landscape and selection of study endpoints
- Project Management (CRO/biotech) experience a plus
- Demonstrated ability to multi-task and manage high performance demands
- Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Regulatory authority inspection experience a plus
- Effective oral, written and interpersonal communication skills.
- Strong organizational and project management skill and the ability to multitask
- Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project)
- Excellent working knowledge GCP, FDA and ICH Guidelines
- Sense of curiosity and willingness to learn, as gene therapy is a fast paced, evolving area of research
- Ability to travel as necessary (approximately 10 – 15 %)
Live an AskLife™
We offer a competitive total rewards package. Are you our next great discovery?