Senior Director, Clinical Operations
Our client is a biopharmaceutical company focused on innovative therapeutics for life threating diseases. They have asked us to assist them in their search for a
Senior Director, Clinical Operations.
Major tasks and responsibilities include:
- Collaborates with executive management to develop appropriate clinical development organization structure, implement hiring plans, and manage the team across functions.
- Develops the overall clinical operations and trial management strategy across the company’s clinical programs.
- Serves as the escalation point for clinical CROs and vendors and holds accountability for vendor performance including project management, data management, safety & pharmacovigilance, medical writing and clinical supplies.
- Interacts with alliance partners including communicating clinical plans, status, risks and mitigations.
- Guides the clinical team to ensure the development of study timelines and ensures operational plans are developed to deliver clinical activities to the defined timelines.
- Supports the clinical team in the design and review of clinical trial documents, regulatory submissions, and reports.
- Ensures the clinical team institutes effective processes with vendors to select and manage clinical sites and the associated vendors.
- Develops strategies to augment vendor activities to support the acceleration of clinical timelines and delivery of high-quality data.
- Mitigates risks and develops action plans to ensure timely completion of clinical trials.
- Ensures quality processes are developed and implemented including vendor and site auditing programs, SOP development and implementation.
- Manages clinical trial budgets and invoicing.
We seek candidates with the following qualifications:
- A Bachelor’s degree in a scientific field is required. An advanced degree such as an MS or PhD is preferred.
- Must have at least 12 years of clinical development experience with biotechnology drug development sponsor companies with substantial early development.
- Experience developing therapeutics for oncology or autoimmune indications is highly preferred.
- Must have a deep understanding of clinical development and the functions needed to support the delivery of clinical studies.
- The ability to manage and coordinate external project teams, consultants, and clinical sites while advancing drug candidates through early-stage clinical trials is required.
- Must have excellent written and oral communication skills.
- Requires the ability to organize and multitask in a highly collaborative and cross-functional environment.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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