Phone: (267) 387-0090
Position Overview
Our client is developing novel therapeutics designed to improve immune cell trafficking including the ability for T-cells to track and destroy cancer cells. They are committed to advancing the field of cancer immunotherapy and immune disorders through innovation and investment in their proprietary clinical and preclinical pipeline.
Reporting to the Chief Medical Officer/Vice President, Clinical Operations, the Director/Sr. Director of Clinical Operations, Rare Disease is an experienced clinical leader focused on the successful management of multiple clinical programs in oncology. The incumbent will work independently and collaboratively in a variety of clinical meetings, projects, and tasks. The Director is an integral member of the Clinical Operations team and is a forward thinker looking to advance the mission and values of the company.
To succeed, the incumbent will have a mindset of putting the patient first and foremost, as well as have a values-driven leadership style where integrity and grit drive all behaviors, decisions, and actions.
Job Responsibilities
- Responsible for the successful management of rare disease clinical programs by day-to-day CRO management
- Acts as a liaison between CROs and establishes quality guidelines to ensure CROs are meeting standards in accordance to the company’s SOP
- Provide strategic input on clinical operations pipeline and goals
- Ensures timely responses to clinical site staff and all regulatory agencies
- Develop working relationships with CROs, key investigators, and other key staff/vendors
- Participate in protocol development as needed
- Serve as a leader to proactively audit and inspect clinical operations activities for efficiency, quality, and progress
- Work on related clinical operations documents and publications as needed
- Collaborate with staff to identify study investigators and sites
- Monitor study progress, data collection, and clean-up for all trials
- Prepare study reports and updates for leadership meetings
- Develop best practices and SOPs as needed
- Supervise and develop the Senior Clinical Research Associate
Job Requirements
- Bachelor’s Degree in the related field
- 10+ years of relevant clinical operations experience in Biotech/Biopharma
- Experience with NDA and BLA submissions
- Familiar and comfortable with clinical operations concepts and operational practices and needs
- History of successful management and interaction with CROs, vendors, and other external clients
- Proven team member that can work unilaterally and collaboratively
- Detail oriented and able to guide clinical operations improvements in a growing company
- Experienced in FDA regulations and other international regulatory agencies
- Prior experience managing direct report(s)
- Proven track record of managing multiple projects and/or programs concurrently
- Self-starter with a positive work ethic
Location(s)
If interested, please send a MS Word version of your resume to [email protected]
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