Associate Director, Clinical Operations

Geron Corporation•United States,

22h•Remote

About The Position

The Associate Director of Clinical Operations is responsible for execution of the clinical trials for the Company’s clinical-stage programs. This position is remote with a periodic presence for in-person meetings in the Parsippany, NJ headquarter office.

Requirements

Bachelor's degree in a scientific discipline or equivalent
Minimum of 7 years of biotechnology/pharmaceutical experience
Previous experience with Phase 2 and Phase 3 studies required
Previous experience managing CROs/vendors
Previous experience with the development of policies and SOPs
Possesses in-depth knowledge of clinical drug development and clinical trial execution
Possesses financial acumen and ability to identify changes in budget scope and address those changes appropriately
Ability to think strategically, but also able to implement tactically, to achieve all program and study deliverables
Strong knowledge of study management and monitoring procedures
Understanding of clinical trials methodology, including a working knowledge of protocols and indications being studied
Well-versed in concepts and practices for clinical trial conduct
Demonstrates excellent knowledge of GCP/ICH, SOPs, and regulatory guidance
Ability to resolve project-related problems and prioritize workload to meet deadlines with minimal guidance and support
Highly self-motivated with the ability to work and plan independently, as well as in a team environment
Results-driven and able to motivate other members of the project team to meet timelines and project goals
Possesses a focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
Demonstrates a high degree of professionalism, as evidenced by punctuality and the ability to deliver on commitments
Understanding of the service culture and ability to maintain positive interactions with internal and external team members and CROs/vendors
Strong interpersonal skills
Polished and efficient communicator, both verbally and in written form
Possesses practical knowledge of IT tools and systems in use on project team

Responsibilities

Provide support to the oncology Clinical Operations team for the implementation of the program clinical development plan
Accountable for all clinical operations deliverables associated with the program, including timelines, budget, vendor oversight, and data quality
Lead and manage the operational team for at least one trial
Support the Head of Clinical Science and Operations in managing relevant CROs, vendors, and clinical program budgets
Ensure completion of study deliverables
Work on trials with moderate to high complexity (in terms of design, location, phase, etc.)
Use operational and therapeutic expertise to optimize trial design and execution
Ensure all clinical trials are executed in compliance with international GCP guidelines and regulations, as well as Company SOPs
Conduct formal presentations to a wide variety of audiences, including colleagues, investigative staff, CROs, and vendors
Proactively identify and resolve clinical project issues
Participate in process improvement initiatives as required
Contribute to the development of SOPs, clinical development plans, and other Company initiatives as required