Associate Director, Clinical Operations
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated AAV gene therapy company dedicated to developing life-saving medicines that have the potential to cure genetic diseases. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for Pompe disease, Parkinson’s disease and congestive heart failure, as well as out-licensed clinical indications for hemophilia and Duchenne muscular dystrophy. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third-generation AAV capsids and promoters, several of which have entered clinical testing. Founded in 2001 and an early innovator in the gene therapy field, the company holds more than 850 patents in areas such as AAV production and chimeric and self-complementary capsids. Learn more at www.askbio.com.
The Associate Director, Clinical Operations 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 AskBio sponsored clinical trials. 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. The ideal candidate should be willing to travel approximately 10-15% of the time.
We are excited about our next Associate Director, Clinical Operations to join the AskBio team!
The Associate Director, Clinical Operations will:
- 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.
- Identify opportunities for increased efficiency and consistency and provides leadership and support to improvement initiatives.
- Deliver expertise to Clinical Operations teams to drive standardization and formulating solutions to complex issues
- Work 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.
- Report 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.
- Collaborate 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
- Participate 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.
- Utilize 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
- Collaborate 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).
- Ensure audit-ready condition of clinical trial documentation including central clinical files.
- Collaborate in the writing and review of study protocols, informed consents and amendments.
- Ensure the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs.
- Ensure Trial Master Files (TMFs) are properly maintained.
Required Education & Experience
- Bachelor’s Degree in scientific or health care discipline.
- Minimum of 5 years of pharmaceutical, biotech or CRO related/clinical research experience.
- CRO oversight experience including feasibility assessments of clinical trials with focus on competitive landscape and selection of study endpoints.
Preferred Skills & Experience
- Experience with Project Management (CRO/biotech), Sponsor Clinical Trial Management and/or Regulatory Authority Inspections.
- 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.
- Effective oral, written and interpersonal communication skills.
- Strong organizational and project management skill and the ability to multitask.
- Computer literacy of Microsoft Office (Word, Excel, PowerPoint and 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.