Director of Clinical Operations
Reporting to the Head of Clinical Operations, this individual will have primary responsibility for clinical trial program oversight within oncology indications. The successful hire will oversee implementation of clinical studies from FIH through commercial marketing authorization in a high quality, timely and cost-effective manner. The successful candidate will ensure that all studies within the program are executed in accordance with US, EU and other governmental regulations as applicable, as well as with appropriate ICH/GCP guidance. The position oversees the Oncology clinical operations development team including CTMs, CRAs, CTAs and other appropriate staff. This person will manage cross functional relationships with internal and external stakeholders and will be extremely hands on fostering relationship development with KOLs. This is a high visibility position with great impact potential.
- Actively participate in strategic planning activities for the Oncology programs including budgeting, resource management and vendor identification/management
- Ensure adequate resources for clinical operations including overseeing operational plans, tactical execution of trials, protocol preparation, report writing, regulatory submissions, etc.
- Develop, implement and maintain operational procedures and processes within the programs
- Ensure alignment of activities/decisions affecting all trials within the programs
- Direct clinical program implementation to meet program timelines
- Lead clinical projects as required including developing the clinical research strategy, supporting investigator and site selection, identifying, evaluating, selecting CROs and managing CRO performance
- Must be available for domestic and international travel up to 20%, dependent on program needs
- BS/BA/BSN – health/science related field preferred
- Minimum 8-10 years of clinical research experience (including direct trial management experience) with five or more years in a small pharmaceutical or biotech environment
- Prior success implementing and managing therapeutic drug Phase I/FIH clinical trials, preferably global in nature
- Prior experience selecting and managing CROs
- Proven excellence in clinical operations strategy including oversight of multiple trials simultaneously
- Ability to foster effective relationships with vendors, investigators and colleagues
- Ability to contribute technical expertise to the various aspects of the clinical trial process.
- Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR
- Excellent communication, writing and presentation skills
- Ability to assess complex issues and propose viable solutions
- MS or advanced degree
- 12+ years of related pharma/biotech experience
- Experience with cell and gene therapy clinical trials
- Experience with clinical development in oncology including CART therapy
- Collaborative – Openness. One Team.
- Undaunted – Fearless, Can-do attitude.
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
If interested and qualified, please include Requisition # 2018-377 the subject line when emailing resume to: email@example.com.
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